Associate Engineering Resume Sample
Dante Lakin
394 Makenna Station,
Detroit,
MI
+1 (555) 829 5410
Work Experience
Associate Director, Engineering
08/2015
-
PRESENT
New York, NY
- Providing subject matter expert guidance to other functions at MSD as well as to mentor/coach other engineers and functions
- Development working relationship with global MSD functions, external manufacturing and third party distribution centers, with whom MSD interfaces
- Identifies and resolves technical and operational problems using lean/six sigma tools
- Expert application of problem solving skills
- Organizing engineering group activities to maintain and grow the business. Maximizing engineering staff’s talents to their job performance. Supervising program managers and other staff on their progress
- Providing guidance to Program Managers, Project Engineers and other engineering staff when issues arise. Coaching the team for best engineering and R&D practices. Taking responsibility for staff’s well-being in work place
- Being an active resolver of problems during the execution of the programs
- Taking a lead role in planning and managing the execution of new product development, product improvements and product cost activities
Associate Director Engineering
05/2009
-
02/2015
Houston, TX
- Overseeing multiple program schedules and budgets and reporting status of projects on a weekly basis
- Developing and implementing policies, standards and procedures for the department
- Ensuring product documentation and specifications are available to support timely procurement
- Maintaining an accessible Product Design History File
- Responsible for managing the development / training (CTAG) and maintenance (Feedback to design) of the operational and design standards/guideline assigned to the Subject Matter Owner of his/her group. The scope of this group includes the management of the expertise (development, succession planning internally, deployment within the category)
- Provide Technical assistance upon request as assigned by the CTCU head
- Assist the CTCU head / R&D Chief engineering to manage the department (OPEX/CAPEX management, regional CMOR & CMLT deputy, Regional single point of contact for CTAG head)
- Working manager for a team of professional staff supporting operations and organizational objectives
Associate Engineering Technicial
02/2006
-
04/2009
Boston, MA
- Provides direct oversight to engineering resources driving continuous improvement, event investigation/management, and project management activities
- Monitors IPT project portfolio in conjunction with project teams to ensure effective management and issue escalation
- Provides technical and process direction through analysis of operating performance and management of key operational data
- Provides vision and direction, along with application of structured problem solving tools for investigation and event resolution
- Drives performance, results, and stability within the department
- Adapts plans and priorities based on departmental strategy and budget to address resource, operational, and supply challenges
- Makes sound compliance and business decisions guided by policies, procedures, and business plans
- Provides leadership and technical guidance to team members and colleagues
Education
Kettering University
2001 - 2006
Engineer's Degree in Chemical Engineering
Professional Skills
- Strong written and verbal communication skills including experience in management of deviation investigations / technical writing
- Highly motivated and possesses excellent interpersonal, problem solving, and technical skills
- Project management skills and experience implementing projects
- Demonstrated data analysis skills using advanced functionality in excel, Parsec, Microsoft access, statistical software packages (Minitab)
- Strong analytical problem solving skills, root cause analysis and risk assessment/mitigation
- Computer usage and typing skills are essential
- Excellent verbal and written communication, including the ability to effectively communicate with internal and external customers
How to write Associate Engineering Resume
Associate Engineering role is responsible for leadership, design, technical, software, engineering, manufacturing, architecture, training, research, integration.
To write great resume for associate engineering job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Associate Engineering Resume
The section contact information is important in your associate engineering resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Associate Engineering Resume
The section work experience is an essential part of your associate engineering resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous associate engineering responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular associate engineering position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Associate Engineering resume experience can include:
- Possesses strong leadership and influencing skills; explains difficult concepts and persuades others to adopt a point of view
- Experience, with 1+ years of leadership experience, and 1+ Agile scrum master experience
- Applies management skills to align staff activities with department objectives
- Keen listening skills & ability to motivate others
- Hands-on experience with electro-mechanical assembly, along with 8 years molding experience
- Experience with process improvement methodologies to improve efficiency and effectiveness
Education on an Associate Engineering Resume
Make sure to make education a priority on your associate engineering resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your associate engineering experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Associate Engineering Resume
When listing skills on your associate engineering resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical associate engineering skills:
- Strong technical and leadership skills, strong business acumen, and strong interpersonal and communication skills
- Demonstrated effective written and verbal communication skills with ability to influence peers
- Operates effectively as a leader in assigned roles on projects, or as PTO representative on multiple teams
- Strong communication, collaboration skills, organization and ability to drive accountability
- Two (2) years’ experience in relevant manufacturing or processing industry (aseptic/sterile, bulk, solid oral dosage, packaging, etc.)
- Infrastructure outsourcing experience with good understanding of ITIL best practices
List of Typical Experience For an Associate Engineering Resume
1
Experience For Associate Director, Engineering Resume
- Good execution and project experience for managing large and complex projects
- Managerial experience in a pharmaceutical manufacturing or packaging environment
- Proven ability to use scientific problem solving and lean manufacturing principles (Examples Include: Hoshin, 5S, Fishbone, Kata) to solve complex issues
- Interest and a proven track record of managing and leading projects
- Experience leading and performing complex technical investigations
- Related Manufacturing experience
2
Experience For Associate Director Engineering Resume
- Extensive experience working with external suppliers
- Able to set priorities, organize time and identify resources for projects
- Working knowledge of high speed filling & secondary packaging equipment
- Working knowledge of regulatory requirements in accordance with cGMP and/or USDA manufacturing operations
- Working knowledge of bioprocessing equipment such as Lyophilizers, Bioreactors, Fermenters, Centrifuges, UF Skids, Process tanks, CIP, Laboratory washers
- Understanding of statistics applied to process monitoring and control
- Understanding of economic and technology scale-up challenges and mitigation techniques in laboratory, pilot, demonstration and commercial scale plants
3
Experience For Associate Spec., Engineering Resume
- Expertise in trouble shooting chemical manufacturing for API
- Provides process support for packaging of vaccines, biologics, inhalers, oral granule sachets, and other specialty formats
- Leads the team and others by providing direction and principle-based guidance
- Creates a culture of inclusiveness and consistency, ensuring consistent application of site policies and performance expectations
- BS, Preferably in Engineering or Sciences
- B.S. in Chemical/Bio ChemicalEngineering or Biological/Chemistry Sciences or related disciplines
- Proficiency in Change Execution Methodology and Behavioral Coaching and Consequence Management tools
- Support, expand and/or manage the proactive process monitoring program for Biologics products
- Recognizes opportunities for continuous improvement and risks; anticipates customer needs, identifies and implements solutions
4
Experience For Associate Engineering Technicial Resume
- Provides ownership for various compliance related initiatives including assumption of key roles within quality management systems, system level improvements, and procedural development
- Ensures team compliance to corporate, site, and departmental procedures designed to ensure cGMP and EHS compliance
- Provides Operations review and approval for Quality Notifications (QNs) and Change Requests (CRs)
- Reviews and approves SOPs and Operations, Technology, or Automation protocols
- Applies advanced problem solving skills and business systems knowledge; collaborates with peers to resolve problems or deviations that cross into inter-related units and uses lean manufacturing principles to implement sustainable solutions
5
Experience For Associate Engineering Specialist Resume
- Directly supports regulatory inspections and audits; works to strengthen compliance posture and inspection readiness
- Strategically and tactfully integrates programs, processes, and ideas that support employee engagement and participation across all levels of the organization
- Influences important business decisions that ensure successful operations and business outcomes in accordance with established procedures, adhering to all domestic and international quality, safety, and environmental guidelines
- Prior leader experience of similarly sized Manufacturing, Maintenance and Engineering teams
- Strong knowledge of ICT infrastructure technologies, able to build customer relationships, articulate our vision and make technical presentations
- In-depth experience with on premise infrastructure, specifically Microsoft technologies (Replication, Trusts, GPOs, etc.), VMware, Citrix, Cisco, and storage
- Experience with cloud systems such as Okta, Office 365, Salesforce, Workday, etc
- Accountable for the performance and results of the business unit
6
Experience For Associate Collaboration Engineering Manager Resume
- Makes decisions, guided by policies and procedures, that impact the unit’s ability to meet performance objectives; consults with next-level manager on an as-needed basis for more complex decisions and/or issues
- Experienced and familiar with TCP/IP networking, Unix servers, Wintel servers, SAN, enterprise backup, infrastructure monitoring, load balancer, firewall, IDS/IPS and high availability solution, application middleware, database, etc
- Certifications such as CCNA/CCNP, MCSE/MCITP are desired
- Suppliers research for unit operations that can deliver partially or totally the required process transformation under development. Contact these suppliers for feasibility of trials at their premises or renting their equipment. Conduct trials at supplier’s premises or coordinate the installation for in house trials
- Adhere to and ensure the compliance of Teleflex’s Code of Ethics, all Company policies, rules, procedures and housekeeping standards
- Providing the strategic leadership, direction, and executive advisement for LANL Engineering Sciences while establishing operational requirements and priorities
7
Experience For Senior Associate System Engineering Resume
- Integrating and delivering key capabilities of the Directorate’s portfolio including, line and program responsibility for three (3) divisions: Accelerator Operations & Technology, Applied Engineering & Technology, and Prototype Fabrication
- Ensures high-quality engineering and engineering science programs and for the development and execution of assigned programmatic responsibilities
- Drives engineering principles and discipline through mentoring, training and project reviews including: PFMEA, Advanced Product Quality Planning (APQP), Dynamic Control Plans (DCP), 8D’s, Project Management and Simultaneous Engineering
- Technology transfers, Investigations, Process Improvements, and Change Control
- Technical support and resolution on quality issues such as Deviations and Product Release
- Functioning independently and providing coordination, communication, and oversight on all technical matters pertaining the external partners assigned in the EMEA region
8
Experience For Associate, Site Reliability Engineering Resume
- TCP/IP, Network Switching/Routing protocols (STP,BGP,EIGRP)
- Responsibility for the technical aspects of fact finding around quality and supply investigations
- Project accountability to execute Technology Transfer and on-going process; support and highlighting the need for the leveraging of shared resources from the global Science and Technology network
- Manage a team of scientists / engineers / investigators while also performing as a lead investigator / analyst
- Serve as Subject Matter Expert in analytical and investigative techniques during Health Authority / Regulatory Agency audits
9
Experience For Associate Maintenance & Construction Engineering Intern Resume
- Manage a small team of scientists / engineers / analysts while also performing as the technical subject matter expert for vendor change control
- Develop and update equipment specifications, approve vendors and products
- Perform, document and publish equipment ratings
- Able to learn details of various cloud IaaS and SaaS services and develop information to assist leadership in decisions
- Able to understand the various on premise infrastructure elements and how these are implemented and managed in a cloud service
- Possess a solid grasp of items related to datacenter management (power, cooling, fault tolerance, cascade failure scenarios, rack layout and cable management, etc.)
- Strong interpersonal skills, with polished presentation Strong written and verbal communications skills, with the ability to present information in compelling and persuasive manner
- Manages team resources and prioritizes as aligned with business needs to include run the Business support (e.g. investigations,), project support, and continuous improvement activities – e.g. improve safety/compliance, reduce cost and increase consistency and efficiency. Recruit and hire team members as necessary
10
Experience For Senior Associate, Engineering Resume
- Serve as site Subject Matter Expert / QMS Sub-System Owner for Filter Validation
- Manage internal/external, indirect/direct validation scientist/contractors as needed based on the sterilization project needs
- Responsible for developing talent and teams’ expertise
- Support / consult / lead product quality and counterfeit investigations across the Merck network
- Keep abreast of analytical and investigative techniques both internal and external to the Merck network
- Serve as site Subject Matter Expert for Single-Use / Disposable Process Components
- Serve as Site Liaison to the Merck Single Use Network
List of Typical Skills For an Associate Engineering Resume
1
Skills For Associate Director, Engineering Resume
- Identify validation improvement initiatives for alignment with current validation best practices
- Interface with global validation group to ensure sterilization validation practices in west point are aligned with Merck & Co., Inc. network
- Provide support to obtain accurate and real time site validation metric to maintain the health validation compliance
- Understands customer (Internal & External) needs to effectively tailor engineering solutions to required service level
- Significant experience in Vaporized Hydrogen Peroxide (VHP) theory and validation practice
- Providing the infrastructure necessary to operate safely and securely in support of the mission and contract requirements
- Experience in the Satellite Communication, Networking or related industry, preferably in Technical Support/System Engineering function
- Experience with infrastructure monitoring, patching, and anti-malware applications
2
Skills For Associate Director Engineering Resume
- Responsible for defending site and company validation policies/practices in front of regulatory agencies during inspections and regulatory submissions
- Support site IPTs during investigations and troubleshooting as a thermal validation/sterilization subject matter expert
- Hands on engineering experience, ideally with Python, MySQL and NoSQL data stores, some PHP
- Experience implementing project QA/QC programs
- Good understanding of mechanical and standardized processes
- Experience integrating on premise and cloud infrastructure
- Generate and approve validation assessment for new or existing changes to sterilization equipment, utilities and processes
- Tertiary qualification in a relevant discipline and/or relevant industry experience
- Support capital acquisition activity primarily in the area of specifying equipment, installation and validation
3
Skills For Associate Spec., Engineering Resume
- Experience with blasting processes
- Experience with CNC processes
- Biologics or vaccine processing experience
- Small and large molecule drug substance experience
- Working knowledge and experience in QMS (Change Control, qualification, etc….)
- Experience in technical and experimental procedures, and methods required
- Experience building modular, event-driven systems at scale
- Experience directly managing agile teams and processes
- Experience working with cloud-based technologies (we use AWS and on-premise hardware)
4
Skills For Associate Engineering Technicial Resume
- Experience in a technical managerial role in the aerospace industry
- Demonstrates a high level of techno-economic awareness and sensitivity
- Utilizing sound scientific and engineering principles for problem solving and implimentation of solutions
- Driving change both internal and external ensuring state of the art technology and processes are implemented and maintained
- Serving as the process Subject Matter Expert (SME) for bulk polysaccharide vaccines during all regulatory inspections and internal audits
- Manufacturing processes and tool design
- Providing technical expert consultation and review on commercial agreements
- Assuring technical site readiness for all new product introductions or transfers
- Participating in periodic Business and Relationship Review Meetings (as appropriate) with strategic partners
5
Skills For Associate Engineering Specialist Resume
- Understanding of ports and protocols; and network infrastructure (routers, switches, etc.) including WAN operations, firewall, and wireless technologies
- Use modelling software to support engineering design efforts and evaluate processing alternatives
- Direct management of a team of scientists and engineers providing coaching, mentoring and technical guidance
- Takes on project management opportunities by leading and participating in process improvement, learning events, or key business sponsored initiatives
- Utilizes packaging expertise to develop value-add solutions to customer needs in packaging and medical devices
- BS in Chemical Engineering, Chemistry, Biotechnology, or other Engineering/Science related Disciplines
- Background in TCP/IP internetworking, general routing, layer 2 protocols, multicast and LAN architecture
6
Skills For Associate Collaboration Engineering Manager Resume
- Document all new ideas for products and/or processes using Arrow’s Intellectual Property Engineering Notebook
- Support new or existing product regulatory filing requirement and provide subject matter expertise review throughout the process
- Manages technical issues relating to the global external manufacturing of commercial Drug Product
- Lead critical technical projects relating to the manufacturing of commercial sterile drug product
- Production requiring partnership and collaboration with manufacturing sites and across the organization
- Understands the criticality of securing early sponsorship and stakeholder alignment for projects and initiatives
- Knowledge of design for manufacturing software
7
Skills For Senior Associate System Engineering Resume
- Independently troubleshoot and debug broad, complex and unique networks solution involving mixed Medias and protocols
- Comply with requirements from Genzyme’s Safety program including EH&S
- Assurance of complaint manufacturing process execution
- Develop design, engineering, maintenance and constructionstandards, and work procedures within the delegation of authority
- A. Provide support for training to Maintenance and Construction
- Full understanding of DNS, domain registrations and SSL Certificates
8
Skills For Associate, Site Reliability Engineering Resume
- Oversees site capital budget and assures timely and compliant execution of capital projects according to the business needs
- This role has been identified as a Rail Safety Worker (RSW)
- Understands the big picture, and how activities link to Merck strategy and business outcomes
- Displays ownership and makes informed cost/ benefit decisions based on analysis of inputs, outcomes, risks and likely return
- Demonstrates the necessary Inclusion skills to integrate inputs and perspectives from various sources, and communicates the decision and its Risk/Benefit implications to key stakeholders and sponsors
9
Skills For Associate Maintenance & Construction Engineering Intern Resume
- Solicits inputs to ensure that customer/ stakeholder needs are at the core of his/her decisions, expectations are met on a consistent basis, and works with a long-term perspective in addressing customer problems
- Expertise in GMP regulations of major markets associated with manufacture of combination products CGMPs, CFR820 and 21CFR Part 4, etc
- Provide expertise to sites involved in manufacturing combination products in terms of meeting combination products regulatory expectations such as quarterly and annual management reviews
- Expert knowledge and proficiency in enabling multiple/complex supply chain nodes associated with manufacturing of combination products including: formulation, device component suppliers, fill packaging, analytical testing and distribution sites
- Provide Technical Leadership to maintain and improve our existing core manufacturing processes
- Participate in defining best practice and generating procedures to standardize best practice where appropriate
- To assist in the development of the engineering talent pool to maintain expertise in our core processes and provide technical career development for engineers
- Support the use of Six Sigma and problem solving tools
- Drive the development of Standard Operating Procedures to define Standard Work content
10
Skills For Senior Associate, Engineering Resume
- To identify and develop new innovative methods and technologies for the advancement of our operations
- Support the development and use of standard Project Management tools
- Collaborate closely with Manufacturing Value Streams by participating with our operators and support engineers in problem solving and supporting resolution with technical experts
- Packaging science experience and/or knowledge
- Experience with hand finishing / polishing processes
- Salary packaging options ( Superannuation/car lease options)
List of Typical Responsibilities For an Associate Engineering Resume
1
Responsibilities For Associate Director, Engineering Resume
- Collaborating effectively with the area Coaches, Operators/Mechanics, support groups (Mechanical Services, Automation, Technology), Quality, and Planning
- Experience with a proven track record of accomplishments, preferably in industrial and commercial scale operations
- Champion EH&S standards, and use knowledge of GMP to advance projects under rapidly shifting priorities and timelines
- Effective at influencing positive change and direction in organization
- Eight (8) + years’ industry experience as an engineer in a Pharmaceutical and/or Biologic Production setting
- Experience with Beta-lactam antibiotics including containment and relevant analytics
- Experience in Tech Transfers into Manufacturing
- Experience in Continuous Improvement, Lean Manufacturing, and Right First Time Methodologies
- Demonstrated ability to work independently as a team leader and team member
2
Responsibilities For Associate Director Engineering Resume
- Experience, including project execution
- Build strong collaborative relationships with internal partners and sites as well as with external partners
- Demonstrated ability to develop innovative solutions for complex problems and business processes
- Experience with Change Control Execution and Management
- Experience with regulatory audits/inspections
- Expertise with Merck validation guidelines, technology handbooks and VTN best-practice communities
3
Responsibilities For Associate Spec., Engineering Resume
- Expertise in clean-out-of-place washers and load pattern design / validation
- Deviation Management, Change Requests and/or Validation or process/product owner
- Experience with Filtration, Single-use Components and Raw Materials
- Construction and process safety experience
- Practical experience with lean construction methods
- Offsite construction experience
- Relevant Naval experience
4
Responsibilities For Associate Engineering Technicial Resume
- Demonstrated use of BIM
- Deviation Management, Change Requests and/or Validation
- Experience in LCMS
- Working knowledge of industrial utilities such as HVAC, HEPA’s, electrical, Plant Steam, Clean Steam, Water for Injection, Deionized Water
- Network Stack (Switching, routing, load balancing)
- Oversees Engineering COE (Center of Excellence) action plans and routinely evaluates status and makes adjustments as needed
- Interacts with senior management in establishing research directions and strategic goals
- Lead to resolve technical issues relating to a product line or major technical projects within Technical Operation
- Lead a small group of Technical Operations staff to manage technical programs and contract manufacturing organizations
5
Responsibilities For Associate Engineering Specialist Resume
- Standards as well as provide bench marking and awareness of industry trends
- Support / consult / lead vendor and raw material product quality investigations for the site and across the Merck network
- Together with the Tier 2 team (Ops, Q, Tech), establishing a calibrated technical oversight approach based on the product type as well as the capabilities and technical competence of an external partner
- Familiar with Database design/operation
- Complete gap assessments for Merck global guidance and perform remediation activities to ensure site compliance
- Manages team resources and priorities as aligned with business needs to include run the Business support (e.g. investigations,), project support, and continuous improvement activities – e.g. improve safety/compliance, reduce cost and increase consistency and efficiency. Recruit and hire team members as necessary
6
Responsibilities For Associate Collaboration Engineering Manager Resume
- Collaborates and engages with multiple functional organizations such as Operations, Technology, Quality, Planning, Automation, Global Engineering Services, Procurement, Finance, Above Site Technology, Regulatory, among others, to develop and maintain processes that meet cGMP and business requirements
- Supports and maintains a site master plan to ensure strategic improvement decisions are considered and proactive improvements are planned and initiated in a timely fashion
- Seeks out and effectively coordinates multi-disciplinary projects that meet commercial and business needs with strong execution of FEL methodology
- Is an effective collaborator, internally and externally
- Gives effective and influential oral presentations at all levels of industry
7
Responsibilities For Senior Associate System Engineering Resume
- Experience in product development, design
- Provides best practices to various site groups ensure equipment performance and reliability
- Collaborates with others to determine URS (User Specification Requirements) meet or exceed the critical control parameters required for new and/or existing manufacturing processes
- Ensures engineering processes and controls meet quality and regulatory requirements
- Coach Engineering and Maintenance teams on best practices, MPS principles and Merck leadership behaviors
8
Responsibilities For Associate, Site Reliability Engineering Resume
- Lead the day-today activity of the engineering team that supports all of IPD’s commercial development operations who easily relates business issues to scientific decisions
- Mentor team members to identify and solve scalability and commercialization challenges through FEL engineering approaches
- Identify and execute FEL development plans, scaling technology developments from bench scale through pilot plant operations and commercial designs, to ensure consistency and reliability in the engineering deliverables
- Participate actively in business development, pilot operations and process development to improve process robustness and performance by suggesting and implementing process improvements
- Executes on challenging and more ambiguous projects to derive the appropriate conclusion to drive progress and innovation
- Manage an engineering team of internal and external resources in the development of engineering drawings, schedules, budgets, equipment datasheets and process SOPs, among other deliverables
9
Responsibilities For Associate Maintenance & Construction Engineering Intern Resume
- Lead and manage a diverse group of personalities to individual and collective success
- Guides broader collaborative aspects of various teams
- Provide technical leadership within Technical Operations, Sterile group for the management of sterile drug product
- Provide direct leadership for day-to-day technical activities for commercial drug product manufacturing –i.e., trouble shooting, process changes and improvements, new manufacturing technology implementation etc
- Lead and act as the primary interface on technical issues between Technical Operations and third-party drug product manufacturers
- Provide technical leadership on Change Controls, investigations, and CAPAs and support of Health Authority Inspections
- Organize and lead ad hoc cross functional teams to manage investigations and implementation of CAPA and change controls
10
Responsibilities For Senior Associate, Engineering Resume
- Project Leadership and Project Execution for both strategic and supply initiatives for critical materials used in biologics
- Interacting and collaborating with vendors and Global Procurement to improve the quality and supply of raw materials as well as implementation of new and alternate raw materials and/or supply chains
- Participate with External Organizations and Consortiums as a Subject Matter Expert in Raw Materials to influence industry
- Soild Line Management – Providing oversight and leadership to a team of support engineers. Coordinate availability of all resources including people, material and supplies to enable right first time execution of the pneumococcal polysaccharide polyvalent bulk
- Leading investigations specifically aimed to prevent deviation re-occurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment. Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc
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