Principal Plant Engineer - PCS FPM

Bayer AG; Berkeley (CA); On-site; USD 112,000 - 169,000; Full time

Job summary

An established industry player seeks a Principal Plant Engineer to lead technical activities in the Final Product Manufacturing department. This role involves optimizing production processes, ensuring equipment reliability, and managing engineering projects. The ideal candidate will have extensive experience in pharmaceutical manufacturing, regulatory compliance, and project management. Join a dynamic team dedicated to innovation and excellence in health solutions, making a tangible impact on the world. If you are passionate about engineering and eager to contribute to meaningful projects, this opportunity is your chance to shine.

Benefits

Health care

Vision insurance

Dental insurance

Retirement plan

Paid time off

Sick leave

Qualifications

• 8+ years of experience in engineering with a focus on manufacturing.
• Hands-on experience with cGMP compliance and pharmaceutical processes.
• Ability to manage projects and troubleshoot equipment issues.

Responsibilities

• Plan and execute production support activities to optimize processes.
• Establish preventative maintenance and reliability programs.
• Manage smaller engineering projects from planning to execution.

Skills

Troubleshooting complex equipment

Project management

Regulatory compliance

Planning and organizational skills

Interpersonal communication

Flexibility for on-call support

Education

Bachelor of Science in Chemical Engineering

Master's Degree in Engineering

PhD in Engineering

Tools

SAP

Building Automation Systems (BAS)

Process Control Systems (DCS, PLC)

Job description

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At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Principal Plant Engineer - PCS FPM

PURPOSE

"The Plant Engineer provides the technical knowledge and is accountable for planning, coordination, and execution of technical activities needed to support Manufacturing Operations in the Final Product Manufacturing (FPM) department."

YOUR TASKS AND RESPONSIBILITIES

Plan, direct, coordinate and execute activities concerned with:

Production Support

• Demonstrate high level of urgency and is able 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 preventative maintenance (PM) and calibration programs;

• Collect, analyze and report equipment downtime information;

• Identify, report and ensures resolution of critical equipment items

• Develop, review and implement recommendations to improve reliability of infrastructure and production systems;

• Specification 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, <$1 million) including planning, detailed design, procurement, construction management, quality, budget and optimization;

• 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 experience starting-up and running new equipment, resolving technical equipment issues, developing turn-over packages, etc..

cGMP Compliance

• Participate in audits conducted by internal and external agencies;

• Resolve Quality action items, write Engineering Assessments as Subject Matter Expert (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, follow through to successful completion;

• Develop network of external contacts appropriate to job;

• Formulate and manage own career path.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

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 an equivalent combination of education and experience;
• Professional registration and/or certifications as appropriate;
• Flexibility to support business requirement of rotational on-call support and / or weekend coverage;
• Demonstrated ability to troubleshoot complex equipment / systems 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, etc.;
• 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, including hands on experience starting-up and running new equipment, resolving technical equipment issues, developing turn-over packages;
• Understanding of industry guidelines, regulatory requirements, and relevant SOPs;
• Proficient computer skills to include Excel, Word and PowerPoint;
• High level of urgency and is able quickly adapt to changing priorities;
• Demonstrated ability to troubleshoot complex equipment / systems and supporting utility services;
• Ability to troubleshoot equipment failures immediately and communicate status to engineers and production;
• Ability to support and prioritize many diverse activities simultaneously while meeting schedule commitments;
• Strong planning and organizational skills;
• Good oral and written communication skills;
• Strong interpersonal skills to effectively communicate with a diverse wide customer base;
• Flexibility to support business requirement of rotational on-call support and / or weekend coverage;
• Experience of Clean Utilities, Water for Injection and Clean Steam Generation Systems;
• Experience on Clean Room Systems, HEPA and ULPA filtration for class 100 areas, be familiar with particle counting and HEPA filter testing and air balancing to achieve pressure differentiation among different room classifications;
• Experience with cold rooms and refrigeration systems, chillers and cooling towers;
• Experience with Boilers and Steam systems, such as condensate return skids;
• Experience with Building Automation Systems (BAS);
• Understanding of P&ID’s and Blueprints for equipment troubleshooting.

PREFERRED QUALIFICATIONS

• SAP experience helpful;
• Reliability engineering experience. Including but not limited to development of equipment preventive and predictive maintenance strategies, Bill of Material development and Inventory optimization for spare parts.

Employees can expect to be paid a salary between $112,200.00 to $168,300.00 . Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc..

This salary range is merely an estimate and may vary based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors.

This posting will be available for application until at least 6-2-25.

YOUR APPLICATION

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.
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.