Bayer Validation Engineer Clinical Manufacturing in Berkeley, California

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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.

Apply online

Validation Engineer Clinical Manufacturing

Your tasks and responsibilities

The primary responsibilities of this role, Validation Engineer Clinical Manufacturing, are to:

Who you are

  • Write and review qualification and requalification (verification, commissioning, IOQ, PQ, PV) documents (protocols, reports, risk assessments, etc.);

  • Document Requalification Reports (DRR) on process and utility systems in Clinical Manufacturing Facility;

  • Examine, review and track validation packages for completeness and accuracy, sound rationale, compliance with validation policies and procedures, and accurate data analysis;

  • Compare results against acceptance criteria and bring exceptions and deviations to management’s attention;

  • Work with Quality Assurance to ensure protocols and reports get approved;

  • Manage external validation contractors to perform needed work;

  • Manage the Clinical Manufacturing Facility validation status lists and validation plans;

  • Actively participate during all phases of qualification: evaluate projects, provide guidance and technical information to others.


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.A. or B.S. in Biology, Biochemistry, Engineering or related science;

  • Six years of experience in Validation, Quality, or Biopharmaceutical manufacturing; OR

  • An equivalent combination of education and experience;

  • Knowledge of the regulatory and cGMP regulations for pharmaceutical manufacturing operations, and validation procedures and practices;

  • Validation experience including one or more of the following areas:

  • Thermal mapping of freezers and sterilizers, process equipment validation, computerized systems validation, utility system validation;

  • Experience drafting Validation Master Plans and Validation Project Plans;

  • Excellent verbal and written communication, interpersonal and communication skills;

  • Ability to communicate knowledge to peers and colleagues from other departments requiring a thorough understanding of processes, equipment, and facilities;

  • Technical Writing;

  • Generating and executing qualification protocols for process equipment (e.g. freezers, sterilizers, incubators, utilities, process skids, PCS systems, etc);

  • MS Word, Excel and Projects experience;

  • Thermal mapping of Freezers and/or Sterilizers;

  • Kaye Digistrip experience.

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