Engineering Validation Associate - CSV

Pfizer • Sanford, NC

5d • Onsite

About The Position

The Engineering Validation Associate supports validation activities within Quality Operations, ensuring that validation work complies with regulatory requirements, company policies, cGMP procedures, and safety regulations. The role evaluates and approves validation plans, protocols, reports, and technical documents; troubleshoots validation issues; and uses statistical analysis to investigate testing results and process anomalies. The associate helps qualify new equipment, determine process capability, and incorporate validated parameters into operating procedures and batch records.

The position also supports project milestones, validation program development, regulatory queries, and deviation investigations, including root-cause identification and corrective and preventive actions. Working under the direction of a supervisor, the associate makes decisions within defined limits and submits work for review. The role collaborates with Quality Operations training stakeholders to support cGMP and site training initiatives, summarizes data in concise reports, and works to meet changing deadlines. The position is primarily day shift and based on premises, with additional work sometimes needed for emergency manufacturing needs, onsite or remotely.

Requirements

• Bachelor's degree with 0 or more years of experience; or an associate's degree with 4 years of experience; or a high school diploma or equivalent with 6 years of relevant experience.
• Excellent attention to detail and a solid understanding of FDA regulations and guidance and Good Manufacturing Practices.
• Strong organizational skills and 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.
• Ability to enter and navigate cleanroom-type environments in manufacturing facilities.
• Permanent work authorization in the United States; U.S. work visa sponsorship is not available.

Nice To Haves

• Technical writing experience, particularly within the pharmaceutical industry.
• Laboratory process validation expertise.
• Working knowledge of equipment qualification and calibration, especially for laboratory equipment.
• Experience with regulatory queries and responses.
• Excellent interpersonal skills and ability to collaborate 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.
• Curiosity about how AI tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.

Responsibilities

• Evaluate, review, and approve validation master plans, protocols, and reports for compliance with regulatory requirements and company policies.
• Troubleshoot validation problems involving equipment and performance processes, and conduct statistical analysis of test results to address process anomalies.
• Write, review, and approve validation process documents and technical reports related to equipment, products, and processes.
• Contribute to project tasks and milestones, organize work to meet deadlines, and apply basic team effectiveness skills.
• Resolve basic problems within limited options under supervisor direction and seek guidance from colleagues when needed.
• Ensure work is reviewed for technical judgment, completeness, and accuracy.
• Execute approved protocols to determine the process capability of new equipment and incorporate defined parameters into operating procedures and batch records.
• Assist with developing validation protocols, managing regulatory queries and responses, and participating in deviation investigations to identify root causes and define corrective and preventive actions.
• Follow company and cGMP procedures and safety regulations, and participate in developing validation programs to stay current with cGMPs and industry standards.
• Collaborate with Business Area Training Leads, Coordinators, and SMEs on cGMP and site training initiatives as a member of the Quality Operations cGMP training team.
• Summarize data into concise reports for review and approval.
• Work additional times when needed to support emergency manufacturing needs, onsite or remotely.

Benefits

• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution.
• Paid vacation, holidays, and personal days.
• Paid caregiver, parental, and medical leave.
• Medical, prescription drug, dental, and vision coverage.
• Eligible to participate in Pfizer’s Global Performance Plan with a bonus target of 7.5% of base salary.
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

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