Validation Engineer III
South San Francisco, CA | Contract
Bayside Solutions is seeking a Validation Engineer III to be part of our Client’ s team in South San Francisco. This is an opportunity to work with a local biotechnical company focusing on the discovery, development, manufacturing and commercialization of medicines to treat patients with serious or life-threatening medical conditions.
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.
Validation Engineer III
- An opportunity to join a patient-focused organization that is driven to develop and commercialize novel drugs for treating rare diseases.
- 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:
Quality Systems Compliance:
- Understand, implement and maintain Pharma Quality Policy and Pharma Quality System (PQS) in the department.
- Use (and create and implement, if necessary) local PTDU-D procedures and templates ensuring alignment with current versions of PQS documents and best practices.
- 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.
- Support the laboratory lead in preparing communications for internal review committees.
- Draft, review and/or approve design control documents (i.e. DHF documents) to support device development deliverables using available templates, such as protocols and reports, comuter system validation, design verification, failure modes effects and analysis, risk management plans, and change management plans.
- Employ good document practices (GDP) when recording data, maintaining archives and drafting and reviewing documents.
- Participate in hazards analyses and design assessments and reviews.
Utilize electronic document archive system and collaborate with Document Control team to ensure document compliance with PQS standards and DHF regulations.
- Plan, lead, and execute computer system validation projects.
- Serve as SME for 21 CFR Part 11, Computer System Validation (CSV), and IT Compliance applicable to GMP environments.
- Work with limited direction. Provide guidance and coordinate work activities with other personnel.
- Plan, implement, and coordinate commissioning and qualification of computer systems (e.g. hardware, software, and accessory systems) for use in regulated and non-regulated operations.
- Review laboratory requirements and define procedures for instrument and data management.
- Implement 21 CFR Part 11 for new and existing testing computerized laboratory instruments and execute qualification in compliance with cGMP requirements.
- Author commissioning and qualification of CSV documents through system life cycle. This includes deliverables such as user requirements, design specifications, qualification protocols, reporting, and support documentation (i.e. traceability matrices, SOP, etc.).
- Support installation activities when needed to ensure proper systems startup and recommend changes to improve system design.
- Regularly interface with staff and leaders in Pharmaceutical Development, Quality and Regulatory Affairs
- Regularly interact with external development partners and equipment suppliers
- B.S, M.S, Ph.D or advanced degree in Science or Engineering.
- At least 5 years of experience computer system validation.
- 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).
- 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.
- Proven track record of working effectively in a matrix organization with a highly cross-functional (e.g., device development, regulatory, clinical, quality, and program management) and collaborative environment is very desirable.
- Excellent oral and written communication skills are required.
- Team oriented, dependable, self-starter.