Verification & Validation Engineer
500 Forbes Blvd., South San Francisco, CA 95688
Bayside Solutions is seeking a Verification & Validation Engineer to be part of our client’ s team in South San Francisco. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Verification & Validation Engineer (Laboratory Operations)
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Searching for an experienced Engineer to provide development and implementation support to project teams developing combination drug delivery devices for parenteral pharmaceutical therapeutics.
- The candidate should have expertise in (verification) testing, systems and methods qualification & validation, maintenance of Laboratory Equipment, and support other engineering and scientific activities within the device development programs.
- The Verification and Validation Engineer will work in the Laboratory Operations group and collaborate across functions (e.g. quality, IT, and vendors) and assist Device Engineers and Laboratory staff in developing practical and thorough solutions to problems, and execute validation activities: method validation, equipment qualification, computer system validation, and method transfer.
- Coordinate and execute commissioning and qualification of laboratory equipment and computer systems (e.g. hardware, software, and accessory systems) for use in regulated and non-regulated operations.
- Author/ review commissioning and qualification documents throughout system life cycle. This includes deliverables such as user requirements, functional/design specifications, qualification protocol/report, and support documentation (i.e. traceability matrices, SOP, etc.).
- Author/ review validation and verification protocols documents to support device development deliverables such as protocols/ reports, test methods, and risk assessments.
- Execute/ lead test method validation, design verification, and method transfer as required by the lab/projects.
- Develop/review/ validate physical test methods to support the selection, design verification, commercialization and marketing of various new combination devices.
- Design test fixtures and perform First Article Inspections.
- Support procurement and installation activities when needed to ensure proper systems startup and recommend changes to improve system design.
- Execute characterization testing to support the selection, design verification, commercialization and marketing of various designs.
- Regularly interact with external development partners and equipment suppliers, Quality, and IT group.
Summary of Qualifications:
- B.S, M.S, or advanced degree in Engineering.
- Knowledge of FDA regulations and knowledge of 21 CFR Part 11.
- Experience in developing and building (test) fixtures, drawing, and CADD/ SolidWorks.
- Knowledge/experience of qualification requirements and procedures for laboratory instrumentation.
- Knowledge of Measurement System Analysis (MSA) and statistical data analysis
- Working knowledge of the development of protocols for validation of instruments.
- Knowledge of Design Controls for regulatory compliance & filing (ISO 13485, etc.), GDP/GLP/GMP, Design History Files, Risk Assessments, etc.
- Excellent oral and written communication skills
- Ability to work in a team, highly organized, and detail oriented
- Six Sigma (Green/Black Belt): DMAIC and DFSS is a plus.
- Experience in computer system validation is a plus.