Senior Specialist QO

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.

In this role you will:

• Apply skills and discipline knowledge to contribute to departmental work and make decisions to resolve moderately complex problems
• Operate 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

• High school diploma (or equivalent) with 8 years of experience or associates degree with 6 years of experience or BA/BS with 2 years of experience or MBA/MS with any 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

• 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

• 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

• 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

• Last day to apply: September 8th 2026.
• Work Location Assignment: On Premise

Work Location Assignment:On Premise

The annual base salary for this position ranges from $82700.00 to $137900.00. In addition this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of lifes moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution paid vacation holiday and personal days paid caregiver/parental and medical leave and health benefits to include medical prescription drug dental and vision coverage. Learn more at Pfizer Candidate Site U.S. Benefits (). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN O-1 H-1B etc.) is not available for this role now or in the future.

To learn more about acceptable and prohibited uses of AI during the recruitment process please review our candidate AI-use guidelines available onPfizer Careers.

Quality Assurance and Control