Validation Engineer I
1000 New Horizons Way Vacaville, CA 95688
Bayside Solutions is seeking a Validation Engineer I to be part of our client’ s team in Vacaville. 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.
Validation Engineer I
- 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:
- Develop and validate mechanical and analytical test methods to support the selection, design verification, commercialization and marketing of various new combination devices.
- Work with project leaders and design engineers to identify, develop, implement and validate new testing equipment and methods to support design verification for novel combination medical devices.
- Write and execute test method validation protocols and reports
- Integrate use of appropriate statistical tools in validation protocols
- Train laboratory staff on new test methods
- Understand, implement and maintain Roche 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.
- 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, design verification, design validation, failure modes effects and analysis, risk management plans, change management plans and design review meeting minutes.
- 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.
Summary of Qualifications:
- B.S., M.S., or advanced degree in Engineering Technology, a physical, chemical or biological science, or the equivalent.
- At least 2 years of experience in the industry and/or academia (including advanced studies) after receiving their Bachelor’ s degree. Industry experience in Pharmaceutical, Biotech or Medical Device is preferred.
- Experience in executing physical test methods, procurement and qualification of equipment, development and validation of testing methods is highly desirable. Expertise in electrical/mechanical instrumentation, data acquisition, maintenance and integrity. Experience in R&D, GLP and GMP environments is preferred, and an understanding of the differences is critical. Experience in developing and building test fixtures and CAD is a must.
- Familiarity with relevant modeling and design tools, design controls and/or statistical analysis.
- Device Design: CAD, Develop and build test fixtures.
- Full data and statistical analysis (JMP, Minitab) and Design of Experiments.
- Design Controls for regulatory compliance & filing (ISO 13485, etc): GDP/GLP/GMP, Design History Files, protocols/reports, hazards analyses, batch records, etc.
- Proven track record of working effectively in a matrix organization with a highly cross-functional and collaborative environment is very desirable.
- Excellent oral and written communication skills are required.
- Highly organized and detail oriented.