Bayer Principal Plant Engineer Purification API in Berkeley, CA, California
Your tasks and responsibilities
The primary responsibilities of this role, Principal Plant Engineer Purification API FS are to: • Optimizes production processes and logistics with regard to safety, environment, cost, quality and regulatory requirements. • Provides key technical input, troubleshoots & resolves problems for technical systems and defines the concepts for new plants, improvement of existing equipment and/or the identification of alternative equipment or installations. • Primary Engineering point of contact and support of large capital projects for API Engineering, including KG-PF, KG-N, and CEB during design, execution, engineering and conformance runs, and launch.
Maintenance / Reliability • Establishes, initiates and analyzes preventative maintenance (PM) and calibration programs • Collects, analyzes and reports equipment downtime information. Identifies, reports and ensures resolution of critical equipment items. Develops, reviews and implements recommendations to improve reliability of infrastructure and production systems, which includes specification and strategy of spare parts needed to meet reliability objectives. • Maintains the Calibration, Maintenance and Safety procedures in defined area of responsibility. • Coordinates maintenance activities and shutdown requirements for API production equipment and facilities.
Project Support, Execution and Management • Provides project management and detailed engineering of smaller projects (AFE,<$1 million) including planning, detailed design, procurement, construction management, quality, budget and optimization. Plans and organizes cross-functional activities. Advances technical project proposals to senior management, following through to successful completion • Provides plant and production input and project engineering support for large projects, (AR, >1 million) cGMP Compliance • Participates in audits conducted by internal and external agencies • Resolves Quality action items, writes Engineering Assessments as Subject Matter Expert (SME) • Performs Risk Assessments and resolution of risk analysis
Who you are
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
Minimum Experience B.S. 8+ years M.S. 4+ years of engineering experience preferably in a reliability function. Experience in a GMP / GLP environment preferred …or an equivalent combination of education and experience Special Skill/Knowledge • Knowledge and hands-on experience with pharmaceutical direct and indirect utility systems, equipment and facilities, cGMP compliance, high purity water systems, clean room HVAC systems, process instrumentation and control systems, etc., are required • Makes independent decisions within defined areas of responsibility. • Understanding of relevant SOPs, Guidelines and Regulatory requirements • Coaches and teaches junior members of the department and provides input to performance evaluations • Ability to perform installation and operational commissioning and qualification testing of equipment and systems. Experience with FAT, SAT, Commissioning and Qualification, including hands on experience starting-up and running new equipment, resolving technical equipment issues, developing turn-over packages, etc. • Demonstrates high level of urgency and is able to quickly adapt to changing priorities • Must be experienced with engineering project execution and project management. • Demonstrated ability to understand complexity of production equipment / systems and their supporting facilities, and utility systems. • Flexibility to participate in rotational on-call support and / or weekend coverage • Proficient computer skills to include excel, word and PowerPoint, SAP experience helpful • Strong planning and organizational skills • Ability to support and prioritize many diverse activities simultaneously while meeting schedule commitments • Good oral and written communication skills • Strong interpersonal skills to effectively communicate with a wide customer base. • In depth process and equipment knowledge of chromatography, TFF, UF/DF, buffer preparation unit operations
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.