South San Francisco, CA 94080
Bayside Solutions is seeking a 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.
- 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:
- The Validation Engineer is responsible for providing development and implementation support to project teams developing combination drug delivery devices for parenteral pharmaceutical therapeutics.
- The candidate has technical expertise in development, qualification & validation and maintenances of laboratory equipment, test methods, and computer systems controlling laboratory instruments, and provides technical expertise to support engineering and scientific activities within the client’ s device development programs.
- The Validation Engineer will work collaboratively across functions (e.g. quality, IT, and vendors), assist Device Engineers and Laboratory staff in developing practical and thorough solutions to problems, and lead and execute validation activities: method validation, equipment qualification, computer system validation, and method transfer.
- This objective will be accomplished by executing activities in the areas of:
- Equipment Qualification and Computer Systems Validation
- Implement and coordinate 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 commissioning and qualification of CSV documents through system life cycle. This includes deliverables such as user requirements, functional/design specifications, qualification protocols, reporting, and support documentation (i.e. traceability matrices, SOP, etc.).
- Review laboratory requirements and define procedures for instrument and data management/data integrity.
- Implement 21 CFR Part 11 for new and existing testing computerized laboratory instruments, perform gap assessments and define resolutions in compliance with cGMP requirements.
- Support installation activities when needed to ensure proper systems startup and recommend changes to improve system design.
- Regularly interact with external development partners and equipment suppliers, Quality, and IT group.
- Method Validation
- Lead and execute test method validation and method transfer, and develop new test methods as required by projects.
- Apply Measurement System Analysis statistical approaches such as Gage R&R for validation of new methods.
- Perform First Article Inspection and design fixtures as needed.
- Author, review and/or approve validation documents to support device development deliverables such as protocols and report, test methods, and risk assessments.
- Understand, implement and maintain Roche Pharma Quality Policy and Pharma Quality System (PQS) in the department.
- Use (and create and implement, if necessary) local procedures and templates ensuring alignment with current versions of PQS documents and best practices.
- Support the laboratory lead in preparing communications for internal review committees.
- Assist with resolving issues arisen from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions.
- Create and review discrepancy, change and risk management documents for PTDU-D and Devices Teams, as appropriate.
- Ensure compliance of training to PQS and job-related requirements.
- Utilize electronic document archive system and collaborate with Records Management team to ensure document compliance with PQS standards and DHF regulations.
- Employ good document practices (GDP) when recording data, maintaining archives and drafting and reviewing documents.
Summary of Qualifications:
- B.S, M.S, Ph.D or advanced degree in Science or Engineering.
- At least 5 years experience with Validation/Qualification.
- Strong knowledge of FDA regulations and experience in implementing 21 CFR Part 11.
- Knowledge of CSV requirements and procedures for laboratory instrumentation and instrument qualification (IQ/OQ/PQ).
- Knowledge of Measurement Syatem Analysis (MSA) and statistical analysis.
- Working knowledge of the development of protocols for the validation of complex computer systems (e.g., multiple GAMP classes of systems).
- Design Controls for regulatory compliance & filing (ISO 13485, etc): GDP/GLP/GMP, Design History Files, protocols/reports, hazards analyses, etc.
- Six Sigma (Green/Black Belt): DMAIC and DFSS.
- Excellent oral and written communication skills.
- Ability to work in a team, highly organized, and detail oriented.