Bayer
Overview
Join to apply for the
Principal Plant Engineer - PCS FPM
role at
Bayer At Bayer we’re visionaries, driven to solve the world’s toughest challenges. This posting includes the responsibilities, qualifications and expectations for the role based in Berkeley, CA. Responsibilities
Production Support Demonstrate high level of urgency and ability to quickly adapt to changing priorities Optimize production processes and logistics with regard to safety, environment, cost, quality and regulatory requirements Provide key technical input for the definition of concepts for new plants, improvement of existing equipment and/or the identification of alternative equipment or installations Ensure production equipment uptime through preventive or predictive measures as well as small modifications and repairs Provide the necessary technical expertise for troubleshooting and resolving problems with Production Unit processes and equipment Maintenance / Reliability Establish, initiate and analyze preventive maintenance (PM) and calibration programs Collect, analyze and report equipment downtime information Identify, report and ensure resolution of critical equipment items Develop, review and implement recommendations to improve reliability of infrastructure and production systems Specify and strategy of spare parts needed to meet reliability objectives Coordinate maintenance activities and shutdown requirements for FPM production equipment and facilities Project Support, Execution and Management Project management and detailed engineering of smaller projects (AFE,
Provide plant and production input and project engineering support for large projects (AR, > $1 million) Perform installation and operational commissioning and qualification testing of equipment and systems; experience with FAT, SAT, Commissioning and Qualification, including hands-on startup and resolving technical equipment issues and developing turnover packages cGMP Compliance Participate in audits conducted by internal and external agencies Resolve quality action items, write engineering assessments as SME Perform Risk Assessments and resolution of risk analysis Understand relevant SOPs, guidelines and regulatory requirements Other Coach and teach junior members of the department and provide input to performance evaluations Make independent decisions within defined areas of responsibility Serve as a consultant to management within a specified area/discipline Advance technical project proposals to senior management and follow through to successful completion Develop network of external contacts appropriate to the job Formulate and manage own career path Qualifications
Required Qualifications
Bachelor of Science Degree from an accredited college or university in Chemical, Electrical, Mechanical Engineering, or a closely related field BS 8+ years, MS 2-6+ years, PhD 0-4 years or equivalent Professional registration and/or certifications as appropriate Flexibility to support rotational on-call and/or weekend coverage Ability to troubleshoot complex equipment and supporting utility services Experience with regulatory and cGMP requirements for pharmaceutical manufacturing Knowledge and hands-on experience with pharmaceutical manufacturing processes, including equipment, utilities, and facilities, cGMP compliance, high purity water systems, clean room HVAC systems, process instrumentation and control systems Knowledge of Bulk Formulation, Sterile Filling, Lyophilization, Packaging and Warehouse Technologies Experience with Process Control Systems, including DCS, PLC, instrumentation and low voltage electrical systems Experience with FAT, SAT, Commissioning and Qualification; hands-on experience starting-up and running new equipment; resolving technical issues; developing turnover packages Understanding of industry guidelines, regulatory requirements, and SOPs Proficient computer skills (Excel, Word, PowerPoint) Strong planning and organizational skills; good oral and written communication Ability to communicate with a diverse customer base and support on-call/weekend requirements Experience with Clean Utilities, Water for Injection and Clean Steam Generation Systems Experience with Clean Room Systems, HEPA/ULPA filtration, particle counting, HEPA filter testing and air balancing for room classifications Experience with cold rooms, refrigeration systems, chillers, cooling towers Experience with Boilers and Steam systems, condensate return skids Experience with Building Automation Systems (BAS) Understanding of P&IDs and blueprints for equipment troubleshooting Preferred Qualifications
SAP experience helpful Reliability engineering experience, including preventive and predictive maintenance strategy development and spare parts optimization Compensation and Benefits
Employees can expect to be paid a salary between $112,200.00 to $168,300.00. Additional compensation may include a bonus or commission where applicable. Benefits include health care, vision, dental, retirement, PTO, sick leave, etc. This salary range is an estimate and may vary based on location, market data, experience, degrees and certifications, and other factors. This posting will be available for application until at least 6-2-25. Application and Contact
Location:
United States :: California :: Berkeley Division:
Pharmaceuticals Reference Code:
844525 Contact Us:
Bayer is an Equal Opportunity Employer/Disabled/Veterans. Bayer provides access and accommodations in its application process for individuals with disabilities; request accommodations via the contact information below. Bayer is an E-Verify Employer. Email: hrop_usa@bayer.com
#J-18808-Ljbffr
Join to apply for the
Principal Plant Engineer - PCS FPM
role at
Bayer At Bayer we’re visionaries, driven to solve the world’s toughest challenges. This posting includes the responsibilities, qualifications and expectations for the role based in Berkeley, CA. Responsibilities
Production Support Demonstrate high level of urgency and ability to quickly adapt to changing priorities Optimize production processes and logistics with regard to safety, environment, cost, quality and regulatory requirements Provide key technical input for the definition of concepts for new plants, improvement of existing equipment and/or the identification of alternative equipment or installations Ensure production equipment uptime through preventive or predictive measures as well as small modifications and repairs Provide the necessary technical expertise for troubleshooting and resolving problems with Production Unit processes and equipment Maintenance / Reliability Establish, initiate and analyze preventive maintenance (PM) and calibration programs Collect, analyze and report equipment downtime information Identify, report and ensure resolution of critical equipment items Develop, review and implement recommendations to improve reliability of infrastructure and production systems Specify and strategy of spare parts needed to meet reliability objectives Coordinate maintenance activities and shutdown requirements for FPM production equipment and facilities Project Support, Execution and Management Project management and detailed engineering of smaller projects (AFE,
Provide plant and production input and project engineering support for large projects (AR, > $1 million) Perform installation and operational commissioning and qualification testing of equipment and systems; experience with FAT, SAT, Commissioning and Qualification, including hands-on startup and resolving technical equipment issues and developing turnover packages cGMP Compliance Participate in audits conducted by internal and external agencies Resolve quality action items, write engineering assessments as SME Perform Risk Assessments and resolution of risk analysis Understand relevant SOPs, guidelines and regulatory requirements Other Coach and teach junior members of the department and provide input to performance evaluations Make independent decisions within defined areas of responsibility Serve as a consultant to management within a specified area/discipline Advance technical project proposals to senior management and follow through to successful completion Develop network of external contacts appropriate to the job Formulate and manage own career path Qualifications
Required Qualifications
Bachelor of Science Degree from an accredited college or university in Chemical, Electrical, Mechanical Engineering, or a closely related field BS 8+ years, MS 2-6+ years, PhD 0-4 years or equivalent Professional registration and/or certifications as appropriate Flexibility to support rotational on-call and/or weekend coverage Ability to troubleshoot complex equipment and supporting utility services Experience with regulatory and cGMP requirements for pharmaceutical manufacturing Knowledge and hands-on experience with pharmaceutical manufacturing processes, including equipment, utilities, and facilities, cGMP compliance, high purity water systems, clean room HVAC systems, process instrumentation and control systems Knowledge of Bulk Formulation, Sterile Filling, Lyophilization, Packaging and Warehouse Technologies Experience with Process Control Systems, including DCS, PLC, instrumentation and low voltage electrical systems Experience with FAT, SAT, Commissioning and Qualification; hands-on experience starting-up and running new equipment; resolving technical issues; developing turnover packages Understanding of industry guidelines, regulatory requirements, and SOPs Proficient computer skills (Excel, Word, PowerPoint) Strong planning and organizational skills; good oral and written communication Ability to communicate with a diverse customer base and support on-call/weekend requirements Experience with Clean Utilities, Water for Injection and Clean Steam Generation Systems Experience with Clean Room Systems, HEPA/ULPA filtration, particle counting, HEPA filter testing and air balancing for room classifications Experience with cold rooms, refrigeration systems, chillers, cooling towers Experience with Boilers and Steam systems, condensate return skids Experience with Building Automation Systems (BAS) Understanding of P&IDs and blueprints for equipment troubleshooting Preferred Qualifications
SAP experience helpful Reliability engineering experience, including preventive and predictive maintenance strategy development and spare parts optimization Compensation and Benefits
Employees can expect to be paid a salary between $112,200.00 to $168,300.00. Additional compensation may include a bonus or commission where applicable. Benefits include health care, vision, dental, retirement, PTO, sick leave, etc. This salary range is an estimate and may vary based on location, market data, experience, degrees and certifications, and other factors. This posting will be available for application until at least 6-2-25. Application and Contact
Location:
United States :: California :: Berkeley Division:
Pharmaceuticals Reference Code:
844525 Contact Us:
Bayer is an Equal Opportunity Employer/Disabled/Veterans. Bayer provides access and accommodations in its application process for individuals with disabilities; request accommodations via the contact information below. Bayer is an E-Verify Employer. Email: hrop_usa@bayer.com
#J-18808-Ljbffr