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.

Emeryville, California is home to one of Bayer's key biomanufacturing operations dedicated to the production of its top-selling drug Betaseron/Betaferon®, a leading therapy for multiple sclerosis. This manufacturing center is the latest addition to Bayer's fast growing biotech operations on the West Coast of the U.S. Along with sites located in neighboring Berkeley and Richmond, Bayer has now developed into the second largest biotech employer in the Bay Area. The company has over 2,200 employees in the Bay Area, dedicated to every aspect of biotechnology

We are currently looking to fill the role of Senior or Principal Mechanical Engineer.

POSITION DESCRIPTION

This position will provide engineering support for site plant engineering and capital project groups.

Tasks of the position include:
- Supporting cGMP Capital Projects as part of a cross-functional capital project teams to upgrade and/or expand critical and non-critical cGMP facilities and associated support utilities.
- Position will be the lead technical specialist and mechanical engineer on the project team with knowledge of cGMPs, building codes, industrial guidelines, and requirements for process equipment and mechanical systems servicing classified spaces.
- The candidate will provide expertise for assessment, design, and installation of HVAC systems engineering, rotating equipment, pressure vessels, plumbing, and piping systems, cGMP facilities, process equipment, building automation systems, and clean utilities (PW, WA, clean steam, clean gases) utilized for the manufacture, or in support of, Biotechnology and Biopharmaceutical products.
- This position will also be responsible for the project management of medium-sized projects, requiring the development of the scope of work, obtaining project approvals, project implementation, cost and scheduling, construction management and oversight, and project documentation as required.
- Function as site HVAC SME and provide plant support to production and other site facilities. Support and drive equipment and system reliability projects.
- Experience with development of engineering documentation (i.e, URS, design specifications, PEP), ability to review, read and understand P&ID and mechanical drawings.
- Execute validation IQ, OQ and PQ protocols as required to support system design.

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

If interested, please apply online at http://track.jobviper.com/ViewJob.asp?id=532969-1281-9369