Validation Scientist Resume Sample
Sydnee Dibbert
1320 Cummings Centers,
Detroit,
MI
+1 (555) 559 2132
Work Experience
Senior Validation Scientist
01/2017
-
PRESENT
Detroit, MI
- Experience in analytical method development, qualification, validation and transfer
- Expert user level experience with many of following techniques: HPLC, LCMS, GCMS, ICP-MS, UV/fluorescence spectroscopy, qPCR, biochemical (enzyme) assays
- Expert knowledge and working application of method validation principles for regulated industries including: FDA cGMP; ICH/USP guidelines ANSI/ISO/ASQC; FMEA, Risk Analysis and Design Controls
- Provides leadership to Validation Scientists (I&II) by delegating projects, training/mentoring, and tracking project progression
- Prepares and executes protocols and written reports
- Reviews documents from team members
- Provides guidance to junior members on various validation requirements (through team meetings and individual interactions)
- Reviews and approves master batch records, deviations and maintenance reports (as qualification is established)
Validation Scientist
09/2011
-
07/2016
Houston, TX
- Attends client meetings as validation representative
- Updates assigned Master Validation Plans (MVPs) as per validation policy
- Provides audit and regulatory support
- Leads / facilitates technical investigations and Corrective Action Preventative Action (CAPA) implementation Supports special projects (as required)
- Performs alternating or rotating shift work (as required)
- B.Sc. in Chemistry, Engineering, or related field
- Previous experience in project management and statistical analysis
- Lead team members
Biodefense Reg Lab Assay Validation Scientist
01/2008
-
05/2011
Phoenix, AZ
- Excellent computer skills (Microsoft Word and Excel)
- Superior writing skills as well strong accuracy and attention to detail
- Excellent interpersonal skills, communication and organizational skills
- Strong judgment, decision making and trouble shooting skills
- Multi-task, meeting tight deadlines in a fast paced environment
- Performs 2nd Review of documents from team members
- Performs verification of data from various validation reports
- Perform 5 year equipment reviews
- Perform regulatory assessments with respect to equipment
Education
Doane University - Crete Campus
2003 - 2008
Master's Degree in Chemistry
Professional Skills
- Experience w/ validation and validation testing for medical device
- Good technical writing skills as well strong accuracy and attention to detail
- Excellent strategic thinker with solid written and verbal skills
- Excellent communication skills both orally and writing
- Strong language skills in German (oral and written) with high proficiency in English
- Experimental design development and execution for validation of new and existing NGS assays, including technical writing of Method Validation Plans and Reports
- In-depth knowledge, understanding, and experience performing lab instrument validation
How to write Validation Scientist Resume
Validation Scientist role is responsible for travel, software, training, database, auditing, reporting, manufacturing, design, research, health.
To write great resume for validation scientist job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Validation Scientist Resume
The section contact information is important in your validation scientist 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 Scientist Resume
The section work experience is an essential part of your validation scientist 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 scientist 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 scientist position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Validation Scientist resume experience can include:
- Assay validation and related method execution, including use of in-house data management software (LIMS)
- Provide database & VBA programming support for Validation metric tools
- Contribute to the design and development of efficient and cost effective manufacturing process for new products
- Writes executable manufacturing process qualification/validation protocols
- Experience in technical or quality operations within the health care industry is an asset
- Represents the organization as the technical expert to endorse the organization’s validation programs and practices
Education on a Validation Scientist Resume
Make sure to make education a priority on your validation scientist resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your validation scientist 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 Scientist Resume
When listing skills on your validation scientist 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 scientist skills:
- Formal training and experience with cGMP expectations, electronic notebooks, electronic data repositories, instrument validation, and SOPs
- Upload and maintain validation database for qualified equipment, process and cleaning validations
- Validation experience in a GMP setting
- Provides key support to Analytical or Micro Testing, Cleaning Validation and Finished Product Release
- Strong ability to form relationships with Product and Vertical Marketing
- Experience with aseptic handling of cell lines
List of Typical Skills For a Validation Scientist Resume
1
Skills For Senior Validation Scientist Resume
- Experience with analytical method development and transfer to GMP labs
- Collect input from various company stakeholders to consolidate comments and resolve conflicts
- Related experience
- Lead verification and validation activities on various hardware and software platforms in support of Thermo Fisher Scientific`s new product development
- NOT Computer Systems Validation
- Develop database for all Validation documentation (database to include query interface, forms, and reports)
- Compile and integrate validation project scope within database
- Generate and execute test scripts for spreadsheet validation
- Other validation support as required (compile data for protocol and report generation)
2
Skills For Scientist Virus Validation Resume
- Generation of testing and manufacturing documentation
- Experimental lot manufacturing and testing
- Capacity to develop a strategic understanding of the Thermo Scientific brand, the life sciences industry, analytical instruments, and software
- Understands existing production instructions and processes
- Understands existing instructions and processes for quality control QC tests
- Supports laboratory personnel in executing written protocols
3
Skills For Senior Scientist Verification & Validation Resume
- Maintains tracking spreadsheets and timelines consistent with project goals
- BS Biology, Biotechnology, Bioengineering
- Compile and integrate qualified parameters for all manufacturing equipment within database
- Presentation of technical information, such as process flows, data and testing results, as required
- Interact with internal and external subject matter experts SMEs to efficiently develop documents
- Assists with data interpretation, and leads preparation of summary reports
4
Skills For Biodefense Reg Lab Assay Validation Scientist Resume
- Prepares documents that conform with quality management system
- Maintains standards and documentation practices that allow for consistent execution of documents
- Completes document control steps for protocols and reports
- Participates in method assessments as applicable and appropriate to meet client’s needs
- Work experience with solid hands-on LCMS background and expertise in small molecules or omics method and applications development – this is a non-negotiable requirement
- Strong domain knowledge of the one or more of Proteomics, Lipidomics, Pharma/Biopharma, Clinical or Food & Environmental analytical industries
- Work in a fast paced multi-disciplinary matrix managed environment
5
Skills For Method Transfer & Validation Scientist Resume
- Present results in a public forum
- Travel 10-15% globally
- Provide technical, process and engineering expertise within a wide range of projects within the IPT, such as the introduction of new equipment and process’s
- Experience in the Pharmaceutical industry or a similar operating environment with experience in a Technical role in a manufacturing environment
- Represents the organization as the technical expert to endorse the organization’s process validation program and practices
- MS + 8 years exp OR PhD + 2 years exp
6
Skills For Process Validation Scientist Resume
- Routine analytical support for production batches / reagents / stability
- Experience in data analysis, technical report writing, root cause analysis and risk assessment. Working knowledge of GMP concepts and cleanroom manufacturing requirements. Knowledge of the Pharma industry/ISO/CFR 21 regulations
- All required reporting in a GMP environment
- Up to 25% administrative/paperwork
- Work independently with little instgruction
- Routine analytical support for instrument qualifications
- Identify database user requirements for cross-functional teams and map conceptual database design
- Consider both back-end organization of data and front-end accessibility for end-user
- Develop, manage and test back-up and recovery plans
7
Skills For Instrument Validation Scientist Resume
- Special project work to support automated swab request program
- Performs Data Analysis and establish data trend lines as appropriate
- Participate in process risk and control solution identification activities
- Generate ideas for continuous improvements into routine Operations
- Advanced knowledge / experience in virology and in several relevant fields e.g. protein assays, protein purification techniques, process development / DOE, pathogen safety, cell culture, validation, GXP requirements
8
Skills For Scientist, Validation Resume
- Experience in the development of ELISA / Western blot based assays is desired
- Understands the basic test in the Laboratory (e.g. HPLC, GC, pH, KF, titration, std preparation, etc) and methodology used in Product or Material Testing
- Leads method development, optimization and validation activities including Analytical Assay Method Development & Validation or Micro Method Suitability, Cleaning method validations including swab recoveries
- Complete all Laboratory tasks on time as required by engineering study or validation protocols and agreed upon timelines
- Identifies suspect data, technical and compliance issues, performs trouble shooting and investigative work
- Reviews peer results, resolves technical issues and supports in auditing for accuracy and compliance
9
Skills For Principal Validation Scientist Resume
- Leads assessment of key laboratory systems and procedures, identifying improvement opportunities
- Support equipment cleaning assessment
- Meets productivity, quality and teamwork metrics
- Maintains compliance with cGMP, SOP’s, and established policies
- Creates compliance solutions to strategic risks. Keeps up on compliance trends
- Provides interpretation of compendia
- Can represent QC in regulatory audits
10
Skills For Computerised Systems Validation Scientist Resume
- Can serve as laboratory investigator for complex investigations
- Selects, develops, and implements new technologies and methodologies
- Writes, Reviews/approves SOPs, Protocols, and Reports
- Assists with deviation investigation, CAPA closures and maintenance reports
- Responsible for metrics and data entry
- Statistical analysis knowledge an asset
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