1360 OâBrien Drive Menlo Park, CA 94025
Bayside Solutions is seeking a Process Engineer to be part of our client’ s team in Menlo Park. 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.
The Process Engineer is responsible for supporting the design, development, qualification and maintenance of cGMP manufacturing facility for commercial cell and gene therapy-based products. This person will provide plant, facility and design support for commercial cell and gene therapy facility which meets customer, business, technical and regulatory needs. The successful candidate will have effective collaborations with internal and external stakeholders, architecture and design firm, general contractors and construction group to support operations.
- Assist in design, installation and commissioning of new equipment and provide engineering technical support for cell therapy and gene therapy operations in commercial facility
- Investigate process or equipment failures and implement changes to prevent future occurrences
- Monitor and analyze manufacturing data as necessary in support of discrepancy/ investigation management, equipment troubleshooting, CAPA/deviations, and regulatory inspections and filing
- Support the design and execution of studies aimed at improving process and equipment robustness/productivity or meeting the changing needs of the manufacturing environment
- Collaborate with manufacturing, facilities, maintenance, process development, quality assurance and/or validation departments in developing requirements and recommendations for processes and/or system modifications
- Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints
- Author and/or review user requirements, specifications, process flow diagrams, P&IDs, systems list, turnover packages etc., as required
Design, Facilities and Utilities:
- Accountable for installation, commissioning, start-up of new equipment and utilities and changes to existing equipment
- Assist validation of new equipment and changes to existing equipment including document generation
- Work with senior engineers and actively participate in the design review process including equipment evaluation, tests, walk-throughs and approvals
Summary of Qualifications:
Require B.S. in chemical engineering, bioengineering or equivalent with minimum 5 years of process engineering and validation support in the Biotech/Pharmaceutical industry.
- Experience working with and knowledge of cGMP, 21CFR Part 210/211/820 and ASTM E2500 guidelines
- Working knowledge of cGMP manufacturing facilities including biologics upstream and downstream operation at minimum
- Proficient in MS Office: Word, Excel, Outlook, PowerPoint
- Excellent written and verbal communication skills
- Knowledge of cell and gene therapy operations and single use equipment a plus