Senior Validation Specialist, Quality Control

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.

Senior Validation Specialist, Quality Control

We are seeking a dedicated and highly skilled Validation Specialist to join our Quality Control (QC) organization. The successful candidate will be responsible for performing computerized analytical instrument qualification, software and spreadsheet validation, and conducting validation periodic reviews to support various labs within the QC organization. This role requires the generation of high-quality validation life cycle documents, including User Requirement Specifications (URS), Risk Assessments (RA), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Your Tasks And Responsibilities

The primary responsibilities of this role are to:

• Conduct computerized analytical instrument qualifications and software validation, ensuring compliance with industry standards and regulatory requirements.
• Generate and maintain high-quality validation life cycle documents such as URS, RA, IQ, OQ, and PQ.
• Demonstrate a strong understanding of validation principles, including user requirements and system specifications.
• Coordinate with vendors and internal resources to support validation projects effectively.
• Manage multiple projects with minimal supervision, troubleshooting issues, and seeking solutions as necessary.
• Plan and prioritize complex and conflicting objectives to meet release goals.
• Ensure compliance with corporate policies, industry standards, and regulatory requirements during validation processes.
• Interact with customers, Quality Assurance (QA), internal and external auditors, and regulatory agencies as needed, supporting regulatory filings with documentation.
• Act as an expert and technical resource for laboratory staff and cross-functional areas.
• Experience in change control, deviation investigations, and Corrective and Preventive Actions (CAPA) to ensure compliance.
• Perform instrument qualification, computer and software validation, validation periodic reviews, and manage validation status lists.
• Generate and/or revise Standard Operating Procedures (SOPs) and maintain all validation-related documentation.
• Utilize various application software programs (e.g., office suites, VISIO, MS Project) effectively, with a strong understanding and experience with Empower at the administrator level.
• Promote and adhere to safety programs regarding health, safety, and environmental protection.
  
  

Who You Are

Bayer seeks an incumbent who possesses the following:

Required Qualifications :

• Bachelor's degree in science or a related field with 6-8 years of experience in the pharmaceutical or related industry, or an equivalent combination of education and experience.
• Minimum of 4 years of experience in performing analytical computerized instrument and software validation.
• Performing qualifications on HPLCs, GCs, FTIRs, DNA Sequence Analyzers, Robotic Dilution Systems, Plate Readers etc.
• Strong understanding of cGMP, 21 CFR Part 11, and global regulatory compliance.
• Excellent technical and business writing skills, along with strong communication abilities.
• Knowledge in risk assessment, change control, and deviation management.
• Proficiency in computer applications, including Microsoft Word, Excel, and databases.
• Strong understanding of Empower Chromatography Data System at an administrator level.
• Excellent organizational skills with the capability to manage multiple tasks effectively.
  
  

Employees can expect to be paid a salary of approximately between $116,625 to $174,938. Additional compensation may include a bonus or commission (if relevant).  Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc..  This salary (or 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 April 14th.

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.

Bayer is an E-Verify Employer.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Location: United States : California : Berkeley

Division: Pharmaceuticals

Reference Code: 841400

Contact Us

Email: hrop_usa@bayer.com