Manager QO (Cleaning Validation)
PfizerAbout the role
Use Your Power for Purpose
At Pfizer, everything we do every day is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, rooted in science and risk-based compliance, is both flexible and innovative, always putting the customer first. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contributions will be instrumental in ensuring that our products meet the highest standards of quality and safety.
The successful candidate will provide quality oversight for cleaning validation program requirements at the Kalamazoo site. This role ensures that cleaning processes, related change controls, and validation documentation align with global Revolution processes and procedures. The ideal candidate will bring relevant skills and experience in cleaning validation.
What You Will Achieve
In this role, you will:
Apply skills and discipline knowledge to contribute to departmental work and make decisions to resolve moderately complex problems
Operate independently in ambiguous situations, determining objectives of assignments and seeking directional review when necessary
Review your own work and potentially mentor others, exercising judgment and becoming a resource for colleagues
Establish and implement cleaning validation strategies, ensuring compliance with corporate policies
Review and approve change controls, ensuring validation impact assessments and appropriate testing including generation and/or review/approval of cleaning validation documentation to maintain validated states
Collaborate with Operations, Quality, Technical groups, and other site/network groups to meet business and compliance requirements
Deliver visual inspection training and provide input to equipment modifications or replacements
Here Is What You Need (Minimum Requirements)
BA/BS with at least 4 years of experience or MBA/MS with at least 2 years of experience or PhD/JD with any years of experience or associate's degree with at least 8 years of experience or high School Diploma (or Equivalent) with at least 10 years of relevant experience
Strong understanding of validation principles and practices
Experience with regulatory requirements and guidelines for validation
Ability to work independently and make decisions in ambiguous situations
Excellent communication and interpersonal skills
Proficiency in computerized systems and software applications
Bonus Points If You Have (Preferred Requirements)
Current or previous experience in role related to cleaning validation
Strong understanding of global Revolution cleaning validation process and procedures
Comprehensive knowledge of GMP regulations and guidance, including 21 CFR Parts 11, 210 & 211, EC Annex 15, and ICH 7
Strong background in problem-solving, negotiations, and data integrity principles
Good understanding of risk management methodologies and their application to pharmaceutical operations
Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance processes
Physical / Mental requirements
Working in a production environment which may include proper gowning for the area
Lifting items (typically less than 25 lbs)
Working with or around chemicals
Position also requires office work, which includes working at a computer workstation
Non-Standard work schedule, travel or environment requirements
Position may require off-hours, weekends and/or holidays to meet business or customer needs
Proper gowning for production areas, including aseptic gowning, may be required
Other job details
Last day to apply: August 18th, 2026
Work Location Assignment: On Premise
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