Bayer HealthCare Pharmaceuticals is a leading global specialty pharmaceutical and biotechnology company. With over $3 Billion in protein drug sales, Bayer ranks as the sixth largest biotech company in the world.

We are currently looking to fill the role of Senior/Principal Mechanical Engineer at our Emeryville site. This position will support cGMP Capital Projects as part of an engineering team. Responsibilities include assessment, design, and installation of mechanical, HVAC systems and process equipment utilized for the manufacture, or in support of, Biotechnology and Biopharmaceutical products.

Position requires the review of the proposed designs for compliance with the project scope and goals, including cost and schedule and satisfying all appropriate codes and/or guidelines, including the cGMPs, building codes, and industrial guidelines.

Position will be the lead mechanical engineer on the project team and will provide expertise in the fields of J-IVAC engineering, plumbing, and piping systems.

POSITION REQUIREMENTS:

Senior Engineer Requirements–

1. B.S. in Mechanical Engineering with at least 5 years relevant experience
2. The candidate shall have experience with working in a FDA or equivalent regulated environment
3. Minimum years industry experience on projects for Biotechnology and Biopharmaceutical facilities
4. Demonstrated experience with mechanical systems or equipment in FDA/EMEA regulated environments,
5. Experience with installing, starting up, and commissioning of cGMP production equipment.
6. Execute validation lQ, OQ and PQ protocols as required to support system design.
7. Advanced understanding of general mechanical, control and instrumentation systems including HVAC, plumbing, and facility/utility operations.
8. Knowledge of local sub-contractors to support installation and startup of systems, as needed.
9. Knowledge of and adherence to local codes, standards, all federal and state statutes and regulations.
10. Knowledge of cGMP requirements and related on-the-job safety training programs.
11. Demonstrated ability to communicate effectively both orally and in writing.
12. Experience with engineering documentation for cGMP systems (ETOP packages, as-built drawings, startup! com procedures, etc)
13. The ability to manage complex tasks within a dynamic project environment.
14. Attention to detail and ability to rapidly respond to project demands and installation problems is critical.
15. Proficient with Microsoft office software (Word, Excel, Power Point, Outlook), and Microsoft Project.

Principal Engineer Requirements –

Mechanical Engineering degree with the following experience:
BS 8+ years
MS 6+ years
PhD 4+ years
Professional registration and/or certifications as appropriate.

1. The candidate shall have experience with working in a FDA or equivalent regulated environment
2. Minimum years industry experience on projects for Biotechnology and Biopharmaceutical facilities
3. Demonstrated experience with mechanical systems or equipment in FDA/EMEA regulated environments
4. Experience with installing, starting up, and commissioning of cGMP production equipment.
5. Execute validation IQ, OQ and PQ protocols as required to support system design.
6. Advanced understanding of general mechanical, control and instrumentation systems including HVAC, plumbing, and facility/utility operations.
7. Knowledge of local sub-contractors to support installation and startup of systems, as needed.
8. Knowledge of and adherence to local codes, standards, all federal and state statutes and regulations.
9. Knowledge of cGMP requirements and related on-the-job safety training programs.
10. Demonstrated ability to communicate effectively both orally and in writing.
11. Experience with engineering documentation for cGMP systems (ETOP packages, as-built drawings, startup, commissioning procedures, etc)
12. The ability to manage complex tasks within a dynamic project environment.

If interested, please apply online at http://track.jobviper.com/ViewJob.asp?id=531604-1281-4169