Associate Principal Bioprocess Automation Engineer - cGMP
About The Position
The Associate Principal Automation Engineer is responsible for defining & applying automation strategies for equipment and facilities within the Biotech-Product Supply network globally. Customers include internal parties, acquired assets and in-licensed assets. Responsibility includes the execution of capital projects across the biotech network and support of existing deployed technologies. This position is part of the global organization, Process Engineering & Technologies (PE&T), that is positioned within Bayer Pharma Product Supply Division. This position is part of Process Eng & Technologies Implementation (PE&TI) group located in Berkeley, CA as well as in Germany (Wuppertal, Leverkusen & Berlin). PE&TI consists of process and automation engineers. Across Bayer Pharma, PE&T is accountable to enable & support (bio-)process operations and to develop Bayer’s cell and gene therapy NextGen processing platforms. This position will support the delivery of bioprocess equipment technologies to Bayer's global Network. This role will be located at our Berkeley, CA site. Relocation assistance may be offered.
Requirements
- Minimum of a Bachelor’s Degree and 8+ years of relevant experience within Biopharma industry; OR
- Minimum of a Master’s Degree and 6+ years of relevant experience within Biopharma industry; OR
- PhD and 4+ of relevant experience within Biopharma industry;
- Extensive experience in the Automation industry with experience in Design, Construction, and Commissioning;
- Significant and relevant experience with capital projects;
- Extensive amount of experience with standard industrial automation technologies, DCSs, PLCs, SCADAs, and HMI programming;
- Strong knowledge of control system philosophy, control system standards, instrumentation configuration, programming, and design in a cGMP environment;
- Strong knowledge of Industrial networks including Ethernet networks, Profibus and OPC communication;
- Strong working experience in working with ISA 88 and ISA 95 levels;
- Technical expert in DeltaV DCS.
Nice To Haves
- Professional registration and/or certifications as appropriate;
- 12+ years of experience in the Automation industry with experience in Design, Construction, and Commissioning;
- 8+ Years of relevant experience in capital projects;
- 12+ Years of experience with standard industrial automation technologies, DCSs, PLCs, SCADAs, and HMI programming;
- Entrepreneurial mindset;
- Mastery of English language, written and oral;
- Good analytical and problem solving (decision making) skills;
- Collaborative team player capable of working well with people across all hierarchies;
- Good organizational and presentation skills;
- Good interpersonal skills such as communication, listening, verbal and assertiveness;
- Must be able to work independently with minimal supervision, multi-task and support several projects simultaneously;
- Result driven and able to deal with ambiguity;
- Ability to work in different geographic locations;
- Willingness to execute projects at remote locations with up to 25% travel.
Responsibilities
- Define, deploy, implement, start-up, and qualify process platform equipment and automation solutions across Cell Therapy, mAb, rFVIII, and other biologics modalities;
- Act as a recognized internal Automation SME and technical authority for equipment platforms, covering installed systems and emerging market technologies;
- Lead hands-on automation project delivery across all phases (feasibility, concept, detailed design, implementation, start-up, qualification);
- Responsible as technical system owner for automation packages, control systems, and user interfaces, translating user requirements into compliant technical solutions;
- Directly support the realization of automation for Bayer’s next-generation Cell Therapy manufacturing platforms and facilities;
- Drive continuity and standardization of automation technologies across the Biotech / Product Supply network while supporting site-based execution;
- Support the implementation and integration of Manufacturing Execution Systems (MES) in new and existing GMP facilities;
- Lead mid-size projects and provide functional leadership and technical guidance to engineers and cross-functional teams;
- Represent Bayer Automation as technical authority in collaboration with external vendors, OEMs, partners, and acquired assets;
- Ensure compliance with GMP, CSV, 21 CFR Part 11, and internal engineering standards and good engineering practices.
Benefits
- Relocation assistance may be offered.
- health care, vision, dental, retirement, PTO, sick leave, etc.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
