Validation Lead Resume Sample
Kendrick Murphy
72477 Jordyn Manors,
Dallas,
TX
+1 (555) 281 3254
Work Experience
Validation Lead
01/2016
-
PRESENT
Los Angeles, CA
- That products and services offered are functional, reliable and safe at the point of entry into service and demonstrably conformant to customer and legal requirements
- Timely approval and acceptance of the product is achieved
- Timely resolution of in-service issues (especially safety) and growth of reliability to meet the contractual obligation
- Work collaboratively to lead a safe and compliant culture in Carlow
- Sound knowledge of GAMP & 21 CFR Part 11 and experience in validation of various COTS, Configurable COTS and Customized IT applications as well as Automation Systems such as PLCs, HMIs, SCADA and DCS
- Good to have experience in using Testing tool such as HP Quality Center / HP ALM tool for testing management
- Good to have Project Management experience
- Responsible for the Validation Strategy in an assigned R&D project i.e., Validation Plan, Clinical Evaluation Sites, Traceability & Evidence Collection
- Manages the stakeholder input for the user and business needs, ensures the needs are compliant with good documentation principles and can be further translated into Validation protocols by the Validation Specialists (Clinical, Human Factor, Installation & Service, Operations)
Lead System Validation Engineer
12/2009
-
08/2015
Houston, TX
- Manages the deliverables of the Validation Specialists for according to Quality Management processes
- Manages the stakeholders during validation activities during development projects
- Coordinates communications of validation activities
- Prioritize and coordinatee the daily activities of the Validation Engineers and Technicians/Validation contractors
- Develop validation protocols to support the qualification/validation of equipment, processes and facilities (e.g.IQ, OQ and PQ protocols, Operational SOPs Change Controls, User/Functional/Design Specifications, etc)
- Coordinate & execute equipment qualification protocols and accurately document results of the defined testing, comparing and reporting those results to predefined/approved acceptance criteria
- Generate and execute all Validation protocols (IQ/OQ/PQ) of all site equipment including production equipment, utilities as applicable) and other related systems in a FDA regulated environment
- Organize and present validation and qualification data, results, documentation and reports within the appropriate equipment/system validation files
- Initiate and execute Corrective and Preventative Actions (CAPA) as required and / or contributing to/supporting CAPAs as needed to resolve deviations resulting from qualification studies
Lead Quality Computer System Validation
09/2006
-
10/2009
Dallas, TX
- Update and maintain Validation Master Plans, Validation Plans, Validation Protocols, Qualification Program SOPs, forms, records to meet cGMPs and federal regulatory requirements
- Ensure timely test completion and result reporting
- Ensure appropriate staff appointment and training
- Implement improvement projects to drive increased flexibility and reduce costs
- Experience/understanding of ICH Q9 Quality Risk Management is desired
- Preparation of project plans, budgets and special assignments. Develop and implements strategic and tactical plans to accomplish business objectives; prepares project budgets and manages to plan
- Author procedures, investigations, protocols, change controls, etc. to support the Maintenance and Engineering departments
- Contribute to the generation and review of required documentation (such as SOP’s, qualification protocols) to support the facilities/equipment requirements
- Database Design Documents
Education
Palm Beach Atlantic University
2000 - 2005
Engineer's Degree in Computer Science
Professional Skills
- Develop strategic relationships; strong verbal and written communication skills; good presentation skills
- Strong validation skills including the following
- Strong MS Office skills as well as strong working knowledge of statistics and analysis tools
- Excellent technical writing skills; experienced in SOPs, protocols, reports
- Strong root cause analysis skills with cGMP experience
- Demonstrated technical and professional skills in validation of a production intent product
- Demonstrated knowledge of validation principles including user requirements, functional specifications, commissioning, IQ, OQ, PQ and process validation
How to write Validation Lead Resume
Validation Lead role is responsible for validation, analysis, customer, leadership, database, finance, training, integration, security, shipping.
To write great resume for validation lead job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Validation Lead Resume
The section contact information is important in your validation lead 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 Validation Lead Resume
The section work experience is an essential part of your validation lead 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 validation lead responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular validation lead position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Validation Lead resume experience can include:
- Provides direction on priorities and ensures that necessary training is in place prior supporting validation activities
- Establish, write, maintain Validation Master Plan for facility, equipment, process, cleaning and packaging validation, through the team of Validation Experts
- Demonstrated experience and excellent knowledge of applicable CSV and IT regulations including the US FDA CFR’s, EU, ICH, as well as the GAMP guidance
- Consolidated validation document: Risk Analysis and Validation Requirement Report( RAVRR)
- Communication skills, including conflict prevention/handling
- Previous experience as an analyst or validation engineer in a manufacturing environment using automation or MES systems is an asset
Education on a Validation Lead Resume
Make sure to make education a priority on your validation lead resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your validation lead 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 Validation Lead Resume
When listing skills on your validation lead 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 validation lead skills:
- Strong report writing and risk assessments skills
- Strong Decision Making Skills: Makes decisions independently on problems and methods
- For formulation demonstrated experience with mixing and filtration process validation
- Demonstrated technical and professional skills to launch a product using various wireless technologies (GSM, CDMA, LTE, etc.)
- Creative and Innovative with proven communication skills both written and verbal
- Strong attention to details, customer focused, organizational, and team skills
List of Typical Experience For a Validation Lead Resume
1
Experience For Lead System Validation Engineer Resume
- Strong analytical, communication, interpersonal and organizational skills
- Excellent people skills across all levels of employment. Comfortable and professional engagement with senior leadership levels
- Previous experience working effectively in globally diverse teams and matrix organizations
- Excellent organizational, documentation, oral and written skills
- Excellent people skills across all levels of employment
- Demonstrable skills in effective oral and written management, customer and team communication to include engagement
- Experience in writing technical documents, especially compliance and/or Validation/quality assurance documents and protocols
2
Experience For Test & Validation Lead Engineer Resume
- Relevant automation validation experience
- Oversees the compliance of validation system and ensures that site can demonstrate system compliance to a regulatory auditor, (e.g. FDA, ANVISA or EMA)
- Priority resource related guidance of site computer validation
- Tracks validation activities throughout the year and authors/revises the site validation master plan (SVMP) accordingly
- Oversees implementation of all aspects of validation lifecycle including periodic review and validation maintenance activities
- Provides technical expertise required for the development of validation life cycle validation documentation
- Engages with local and global validation experts to ensure incorporation of best practices within the validation program
- Self- motivated and able to work effectively independently without minimal supervision
- Proven experience with IT Risk Management and Control policies and procedures
3
Experience For Lead Quality Computer System Validation Resume
- Strong knowledge and experience with the Windows Office Suite
- Validation & project management & experience essential
- With knowledge of the Clinical User and experience in project management, change management, IT, GCP (good clinical practices) & study design
- Demonstrate proactive initiative and ability to adapt to changing priorities
- Ensuring SDLC/CSV/Qualification activities are conducted in a cost effective manner
4
Experience For Lead Subsystem Validation Engineer Resume
- Participate on project teams providing assistance/guidance on collecting, compiling and reviewing data in supports of validation studies
- Support QA in establishing, writing, and maintaining Validation Master Plan for computerized systems
- Is knowledgeable in all the following validation disciplines
- · Provides validation subsystems and components expertise to System Engineering Team in order to successfully meet program deliverables
- Provides validation subsystems and components expertise to System Engineering Team in order to successfully meet program deliverables
- Design and deliver technical training on validation policies and procedures
5
Experience For Project Lead-VP AML Scenario Management & Validation Resume
- Good communicator and optimizing collaboration between different departments
- GmP/Manufacturing experience with technical background
- Manages team’s workload priorities and identifies roadblocks to group lead or manager
- Experience with Emerson Controllers and Emerson DeltaV Software is required
- Write and justify Process Validation development strategies and review subsequent protocols and report drafts as written by the (Senior) FFP specialists
- · Responsible to work with and coordinate validation activities across multiple SMT areas as required by features/system
- · Perform read across for validation testing
6
Experience For Validation Team Lead Resume
- · Provide the validation input into the program specific SORs- Appendices C2, VCRI, System Technical Specification (STS), and G2
- · Ensure optimized hardware plans in support of program-level LADV plans for system-level validation
- Prepare, Review & Approval of validation documents / protocols (VMP’s, URS, RTM, DQ, IQ, OQ, PQ & VSR’s)
- Prepare , Review & Approval of validation documents / protocols (VMP’s, URS, RTM, DQ, IQ, OQ, PQ & VSR’s)
- Direct management of Validation Engineers & Specialists across both sites
- Partner with Engineering, Manufacturing and IT to define the process validation/ equipment/systems qualification interface
- Manages contract validation staff for the Upper Merion clinical sterile manufacturing site
- Reviews validation documentation and ensures consistent delivery across all supported operations (Sterile, Microbiology, WREF)
7
Experience For Turn-by-turn Functional Lead Validation Engineer Resume
- As required, supports execution of approved validation protocols
- Supports or leads interactions with internal/ external auditors on matters pertinent to validation
- Develops and monitors key metrics for turnaround of validation deliverables and drives continuous improvement with respect to both compliance and efficiency
- Author and Review Validation Summary Report
- Demonstrated ability to work with cross-functional teams in Systems, Design, Release and Suppliers
8
Experience For Process Validation Lead Resume
- Develop and oversee site-wide validation program(s) with the relevant functional areas
- Experience in vaccine and/or large molecule process development, lifecycle management and/or manufacturing
- Experience in a GMP environment
- Experience in People & Team Management
- Formulation process validation
- Maintains Site Validation Master Plan
9
Experience For Technical Lead-validation Resume
- Computer System Validation and
- Ensures escalation of validation state
- Able to provide technical validation support and leadership
- A Self-starter, quality-conscious, excellent communicator, a problem-solver and a team player
- BS or above with an IT focus, or equivalent combination of education and experience
10
Experience For Telematics System Validation Lead-autonomous User Experience Resume
- Participating in the delivery of system solutions by documenting SDLC/CSV/Qualification activities
- Staying abreast of new technology/competitive products in the field of wireless technology
- Coaching of the DPD sub-teams to become ProVal experts
- Climbing a mobile ladder and/or other types of ladders on occasion with or without reasonable accommodation
- Working knowledge of DoD Pentagon headquarters agencies
List of Typical Skills For a Validation Lead Resume
1
Skills For Lead System Validation Engineer Resume
- Meet established validation and revalidation milestones according to approved validation plans
- Maintain overview of state of validation at Site and establish the validation related project prioritization across site
- Updating Validation Scorecards/PQMS for feature validation
- Expert in reviewing and writing technical reports and risk assessment skills
- Proven project management experience leading cross-teams
- Demonstrable skills in taking process or task ownership and distribution
- Proven ability to manage multiple priorities and make sound decisions in a fast-paced and changing environment
- Recent hands on experience executing process validations
- Experience in validating telematics hardware, in particular call flows and component interaction
2
Skills For Test & Validation Lead Engineer Resume
- Prepare Validation Strategy and Validation Plan and Reviewing them
- Work effectively under pressure and comply with timelines
- Communicate clearly and effectively in a timely manner with all members of the unit
- Demonstrated ability to own and present site validation programs with internal and external auditors
- Ensure a proper prioritization approach for Highlevel Product Assessments, product validation, compliance activities
- Establish, write, maintain Validation Master Plan for site validation activities
3
Skills For Lead Quality Computer System Validation Resume
- Driving system failure mode understanding into validation plans with the objective of reducing safety or compliance recalls
- Participating in system DFMEA, V&V planning, and Fault Tree Analysis reviews, incorporating any findings and learnings into validation plans
- Providing validation/verification/qualification training to stake holders as necessary
- Working with and coordinating validation activities across multiple System Management Team areas as required by features/system
- Participating in system DFMEA, Verification &Validation plans & Fault Tree Analysis and incorporating findings and learnings into LADV plans
4
Skills For Lead Subsystem Validation Engineer Resume
- Partaking in regulatory, corporate and internal audits as required & ensuring validation documents are in a state of “audit readiness”
- Guiding and Training Project Team members on Computer system validation concepts, policies and procedures
- Understanding of feature/systems requirements and the ability to translate the requirements into validation test procedures and use cases
- Executing validation/qualification/verification/migration strategies per company procedure(s)
- Defining validation criteria and methods for vehicle level feature/system definition and functionality to meet performance requirements of autonomous vehicles
- Ensuring optimized hardware plans in support of program-level LADV plans for system-level validation
- Training & development of Validation Engineers & Specialists across both sites
- Understanding of process, analytical validation, and system qualification
5
Skills For Project Lead-VP AML Scenario Management & Validation Resume
- Understanding of EU annex 1, 11 and 15, FDA process validation guideline, ISO standards, ICH guidelines, ISPE and PDA guidelines
- Managing overall computer system lifecycle and validation deliverables
- Experience with modeling manual and automated test procedures simulating CAN network messaging
- A working knowledge of, and experience generating life cycle documentation such as URSs, FRSs, and SDSs
- Experience in manufacturing/ manufacturing science and technology/technical development/Quality
- Experience in pharmaceutical aseptic compounding environment, working with multiple departments / disciplines (Production, QA, Microbiology, Finance )
- Proficiency using Validation Test Instrumentation (Multimeter, Tachometer, Non-viable Particle Measuring, etc.)
- Good Knowledge in scripting language (windows batch script, Power shell, Perl)
- Experience on scripting languages like Perl, Python or equivalent
6
Skills For Validation Team Lead Resume
- Develop validation deliverables including but not limited to
- Excellent knowledge of utilities and general production systems used in non-sterile pharmaceutical manufacturing
- Strong team player, willing and able to support other team members as needed to achieve project goals
- Work with limited requirements/data and make effective decisions while emphasizing customer consideration and impact
- Experience working on Conveyor Belt Systems with a Pharm or Medical Device environment
- Proficiency with Kaye Validator and Temperature Mapping
- Continuously looking for improvements to match requirements from pharmaceutical companies with scheduled hours per project for validation activities
- At least five years of professional engineering experience
- Experience with managing test tool properties
7
Skills For Turn-by-turn Functional Lead Validation Engineer Resume
- Experience with CANalyser, CAPL Scripting and Vector Tools
- Strong background working in cGMP environments
- Experience with the following hardware: Allen Bradley PLCs and I/O
- Provide periodic review of existing systems for validation compliance
- Develop & maintain a suite of Metrics and KPIs, to provide direction and reporting information for teams and management in the area of Validation
- Responsible for ensuring the quality of facility systems (validation)
- Ensures program compliance with GSK global quality policies pertaining to validation
- Provides validation planning for complex projects
8
Skills For Process Validation Lead Resume
- Good knowledge in ISO 14443, ISO 7816 protocols, MIFARE
- Experience in version control system like SVN, GIT
- Experience in communication protocols (ISO14443, ISO7816, UART, I2C, SPI, SWP)
- Experience of Protocol Analyzers
- Experience of GAMP 5 framework
9
Skills For Technical Lead-validation Resume
- Excellent knowledge of medical device regulations
- Author complex validation protocols (e.g. launches, transfers, weak point remediation)
- Be a senior advisor in case of difficult validation challenges at Site
- Understand potential risk areas/shortfalls and make sure that the site validation program is always inspection ready
- Managing operational delivery activities in line with defined targets and priorities
- Provide input into authoring of complex validation protocols (e.g. complex automated equipment)
10
Skills For Telematics System Validation Lead-autonomous User Experience Resume
- Own the Training Curriculum for Validation Lead
- No critical/major observations during audits/inspections, processes and equipment maintained in constant state of validation
- Technical writing abilities and good time management
- Preparing, Reviewing and Approving various Test Cases for IQ, OQ, PQ, Regression testing, System testing
- Supporting System Engineers in defining interface requirements across System Management Teams and Integration areas
- Creating CLL PRTS for any issues requiring changes to FTS/feature FMEA
List of Typical Responsibilities For a Validation Lead Resume
1
Responsibilities For Lead System Validation Engineer Resume
- Encourage the team to learn new skills which can help Cook MyoSite, Inc
- Validation and qualification experience of biopharmaceutical or healthcare industry
- 8-years Pharmaceutical validation experience in a GMP regulated environment
- Good understanding of manufacturing processes as well as computer systems
- · Leads defining validation criteria and methods for vehicle level feature/system definition and functionality to meet performance requirements
- Development, implementation and improvement of validation standards for process characterization studies e.g. reduced scale model qualification
2
Responsibilities For Test & Validation Lead Engineer Resume
- Have oversight over the DP Lifecycle Process Validation approaches across all Janssen Vaccines’ projects
- Delivery of reviewed and approved ProVal related strategies, protocols, reports and validation plans
- Team Lead for oversight of all Validation Lifecycle components
- Represent Validation department inside or outside company meetings
- Apply lean and six sigma principles to the validation functions
- Perform qualification and validation functions as required
- Understand the qualification and validation requirement of technology transfer process
- Sign-off of PVCL for feature level validation
3
Responsibilities For Lead Quality Computer System Validation Resume
- Proven ability to work and through with key plant functional groups without direct authority
- Performing complex design and root cause analysis, engaging interface SMT’s and other subsystems as needed
- Performing Risk Assessment and Gap Assessment
- Managing off shore team/testers
- Physically capable of standing, stooping, kneeling, climbing, reaching, twisting and bending
- Responsible for creating the documents required for the commissioning and qualification activities
- Interacts with Contract Engineering, GSK Engineering, GSK maintenance, Pharmaceutical Development, and other support staff locally and internationally
- Act as a champion for Quality Culture and ensure a safe working environment by following all hazardous materials/waste management regulations and guidelines
- Self motivated and willing to be pro active in resolving issues
4
Responsibilities For Lead Subsystem Validation Engineer Resume
- Support testing in either an IT or Business area, ensuring compliance with all company and departmental policies, procedures and standards
- Knowledge of API, Biopharmaceutical manufacturing & Parenteral manufacturing Facilities and Equipment, Stability Chambers and Microbiology equipment
- Vulnerability scanning using approved DoD scanner
- Analyzes and interprets resulting data from tests (determines data anomalies)
- Participate in resolution of issues involving interface SMT’s and other subsystems.
- Participate in resolution of issues involving interface SMT’s and other subsystems
5
Responsibilities For Project Lead-VP AML Scenario Management & Validation Resume
- · Lead/Create test procedures for all Feature Technical Specifications/ System Technical Specifications, including performance requirements
- · Support System Engineers in defining interface requirements across SMTs and Integration areas
- Responsible for ensuring FDA regulations are met for system upgrades/replacements
- Supports activities associated with the performance of Safety Risk Assessments for manufacturing systems
- Perform trending of key metrics for the department that can increase operational excellence
- Guide the team during internal or external conflicts
- Identify internal or external training that can enhance department's knowledge
- Consult with outside experts and utilize the knowledge to create a “controlled state” manufacturing
6
Responsibilities For Validation Team Lead Resume
- BS in Electrical, Computer, Aerospace engineering or equivalent
- Manage Site Risk Management Program to ensure end-to-end technical oversight of product transfer and manufacturing
- Familiarity with manufacturing process and assembly operations and their effect on components/systems’ function
- To be able to establish working relationships with other support and production areas in order to gather all of the necessary information required
- Thoroughly understands the difference between Positive versus Negative Testing
- Knowledge of manufacturing facility design and operation
- BS in an Engineering or Science Discipline
- Visual and manual acuity for working with computers and telephone communication
- Majority of some days spent on feet in laboratory setting
7
Responsibilities For Turn-by-turn Functional Lead Validation Engineer Resume
- Fluent in English and willing to travel
- UAT Reports(User Acceptance test Protocol, User Acceptance Test Script, User Acceptance Test Report)
- Providing comprehensive, “end to end”, system-level technical leadership for Global Telematics test and development activity across functional domains and organizations
- Working with TIE to specify validation procedures and deliverables at key interfaces, ensuring system-level interface requirements are covered in validation plans and are assigned for execution
- Communicating, coordinating, and consulting with Systems Engineering and other engineering departments to drive product and feature requirements, design, strategy, and interface requirements across domains
- Support ADV process to reduce Hardware and to realize RLM (Road- Lab-Math) strategy
8
Responsibilities For Process Validation Lead Resume
- Coordinate work with internal and external customers and suppliers
- See Code of Federal Regulations, Title 42, § 493.1489 Standard; High Complexity Testing Personnel Qualifications. AND Have at least three years of laboratory training or experience, or both, in non-waived testing
- Education outside of the United States requires diploma/transcripts translated into English and proof of foreign equivalency from by an HHS approved agency or nationally recognized organization such as NACES (National Association Credential Evaluation Services, Inc) or AICE (Association of International Credential Evaluators, Inc)
- Set up ProVal(QbD) strategy/policy for DPD in alignment with the company ProVal strategy and increase expertise within the organization by training on these strategies
- Representative of DPD/FFP in the Janssen Vaccines Proval Expert Team. This team supports the process validation activities for the different disciplines, DS and DP
- Responsible for on the job training and coaching of team members on ProVal activities including criticality assessments, batch analysis evaluation, process characterization and resulting process validation plans
9
Responsibilities For Technical Lead-validation Resume
- Development, implementation and improvement of standards (SOP templates and/or guidelines) for Lifecycle Process Validation (QbD, PPQ, Continued Process Verification) for mono- and multivalent vaccines
- Develop and share best practices for process characterization, criticality analysis, control strategy, DoE approaches and PPQ design and execution as well as for leveraging platform knowledge
- Keep regulatory and Quality expertise up-to-date, screening EU and US regulatory evolutions
- Actively partner with stakeholders such as PDMS, JSC, RA, QA to drive consistency and compliance for ProVal
- Responsible to discuss any unresolved questions in the ProVal Expert Team and relay on the output of the project teams
- Link with JSC/New Product Leads to define the commercial batch size and source commercial production capacity to be Tech. Transferred
- Responsible to provide timely process validation support to the individual projects teams based on regular development stage input received on DPD (FFP) projects by the either FFP lead or via TI or CMC lead
- Responsible to lead and report criticality assessments, ProVal strategies, support execution (ProChar) and interpret subsequent reported output (PAR/NOR-MOR ranges) as input for ProVal (PPQ, PVMP) initiation and reporting
10
Responsibilities For Telematics System Validation Lead-autonomous User Experience Resume
- Support all Janssen Vaccines’ projects (depending on the individual availability and project priority) for the Process Characterization and Validation approach, from Life cycle Stage 1 up to continued commercial production
- Pro-active identification of issues, problem-solving capabilities, and timely implementation of solutions concerning ProVal at external partners (CMO’s)
- Identify and implement improvements in the way of working derived from applicable regulatory guidance’s
- All-round expert in quality, regulatory, technical and business aspects of external manufacturing
- Keep regulatory and Quality expertise up-to-date, screening relevant internal -, as well as EU and US regulatory evolutions
- Adherence to TI model (communication, escalation, project alignment)
- Collaborates with Engineering and Technical Departments to ensure validation activities are completed to GSK standards within project timelines. The quality of the validation program has a direct impact on compliance to cGMP’s and the ability of the site to gain and sustain regulatory approval to supply products
- Complies with all Safety / FDA / Quality regulations and local / corporate policies and procedures
- Ensures quality and compliance in accordance with established procedures and standards of the Quality System
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