Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

Principal Plant Process Active Pharmaceutical Ingredient Engineer

Your tasks and responsibilities

 

The primary responsibilities of this role, Principle Plant Process API Engineer, are to: 

 

  • Production Support:
  • Optimize production processes and logistics with regard to safety, environment, cost, quality and regulatory requirements;
  • Provide 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;
  • Maintenance / Reliability:
  • Establish, initiate and analyze preventative 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, which includes specification and strategy of spare parts needed to meet reliability objectives;
  • Maintain the Calibration, Maintenance and Safety procedures in defined area of responsibility;
  • Coordinate maintenance activities and shutdown requirements for API production equipment and facilities;
  • Project Support, Execution and Management:
  • Provide project management and detailed engineering of smaller projects (AFE, <$1 million) including planning, detailed design, procurement, construction management, quality, budget and optimization;
  • Plan and organize cross-functional activities;
  • Advance technical project proposals to senior management, following through to successful completion;
  • Provide plant and production input and project engineering support for large projects, (AR, >1 million) cGMP Compliance;
  • Participate in audits conducted by internal and external agencies;
  • Resolve Quality action items, writes Engineering Assessments as Subject Matter Expert (SME);
  • Perform 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:

 

Required Qualifications:

 

  • B.S. Degree in Engineering or related discipline;
  • B.S. with eight or more years of experience;
  • M.S. with four or more years of engineering experience preferably in a reliability function; OR
  • An equivalent combination of education and experience;
  • 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;
  • Make independent decisions within defined areas of responsibility;
  • Understanding of relevant SOPs, Guidelines and Regulatory requirements;
  • Coach and teach 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.;
  • Demonstrate 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.

 

Preferred Qualifications:

 

  • Experience in a GMP / GLP environment.

Your application

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.

 

Country: United States
Location: CA-Berkeley