1000 New Horizons Way Vacaville, CA 95688
Bayside Solutions is seeking a Distinguished Engineer 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.
- 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:
- 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.
- The incumbent in this position will be responsible for supporting activities within Device Development department and facilitating product development towards the goal of commercialization.
Summary of Qualifications:
- B.S, M.S, Ph.D or advanced degree in Engineering, with preference for Mechanical Engineering or the equivalent.
- At least 15 (15 in Corporate Levelling) years of experience in the industry and/or academia (including advanced studies) after receiving their Bachelors degree.
- Experience in DOE, problem solving and modelling using physical rules is expected. Expertise in 6-sigma as a green or black belt and also must have a good understanding of statistics. Working knowledge of manufacturing, quality control, preclinical and clinical development and regularity issues pertaining to combination products is preferred.
- Expert knowledge of relevant modeling, design controls and/or statistical analysis.
- Modeling: Monte Carlo Simulations, Tolerance Analysis, Finite Element Analysis, Probabilistic Design.
- 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.
- 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., manufacturing, quality control, preclinical and clinical development and regulatory) and collaborative environment is very desirable.
- Excellent communication skills are required. Experience in working with external development partners and component suppliers is also highly desirable.
- Highly organized and detail oriented
- Excellent leadership skills.
- Must be able to serve as primary consultant to senior management and top executives.
- Expected to create formal networks with key decision makers.