Validation Engineer

Pfizer • Middleton, WI

8d • $68,600 - $114,300 • Onsite

About The Position

We are seeking a detail-oriented and motivated validation professional to support qualification, validation, and compliance activities in a regulated manufacturing environment. In this role, you will help ensure equipment, processes, and systems meet regulatory requirements and company standards through protocol execution, technical documentation, data analysis, and problem-solving. Working collaboratively with cross-functional teams, you will contribute to validation projects, support investigations and risk assessments, and play a key role in maintaining compliance with current Good Manufacturing Practices (cGMP) while driving continuous improvement.

Requirements

• Excellent attention to detail and a solid understanding of Food and Drug Administration Regulations/Guidance and Good Manufacturing Practices
• Strong organizational skills and the ability to manage changing deadlines
• Proficiency in Microsoft Office, particularly Excel, for data evaluation
• Strong written and verbal communication skills
• Ability to work in a team environment and collaborate effectively with colleagues
• Basic understanding of validation principles and practices
• Permanent work authorization in the United States.

Nice To Haves

• Technical writing experience, particularly within the pharmaceutical industry
• Working knowledge of equipment qualification and calibration
• Excellent interpersonal skills and the ability to work collaboratively with cross-functional teams
• Adaptability and flexibility in a dynamic work environment
• Commitment to continuous learning and professional development
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

Responsibilities

• Evaluate and review protocols, periodic reviews and reports, ensuring compliance with regulatory requirements and company policies.
• Troubleshoot validation problems for equipment and performance processes, conducting statistical analysis of testing results to address process anomalies.
• Write and review validation process documents and technical reports or risk assessments related to equipment, products, and processes.
• Contribute to or lead project tasks and milestones, organizing work to meet deadlines and applying basic team effectiveness skills within the immediate Work Team.
• Make decisions within limited options to resolve basic problems, working under the supervisor's direction and seeking guidance from colleagues.
• Ensure work is regularly reviewed for technical judgment, completeness, and accuracy, exercising judgment with reliance on the supervisor.
• Determine the process capability of new equipment through the execution of approved protocols, incorporating defined parameters into operating procedures and batch records.
• Assist with the development of validation protocols, manage regulatory queries and responses, and participate in deviation investigations to identify root causes and define corrective and preventative actions.
• Adhere to all company and Good Manufacturing Practices (cGMP) procedures, safety regulations, and participate in the development of validation programs to stay current with cGMPs and industry standards.

Benefits

• 401(k) plan with Pfizer Matching Contributions
• additional Pfizer Retirement Savings Contribution
• paid vacation
• holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level