Associate Validation & Qualification

Overview

Associate role in Validation and Qualification within Pfizer's Quality Operations, supporting technology transfer, validation activities and cGMP compliance.

What you'll do

• Support technology transfer activities, including execution of laboratory, scale-up, exhibit and validation batches.
• Prepare and review study protocols, technical assessments and scientific reports to support process understanding and product readiness.
• Support preparation and review of technical documentation and responses for regulatory submissions and deliverables.
• Evaluate, review and approve validation master plans, protocols 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, review and approve validation process documents and technical reports related to equipment, products and processes.
• Contribute to 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 and safety regulations, and participate in the development of validation programs to stay current with cGMPs and industry standards.
• Work effectively as a member of the Quality Operations (QO) cGMP training team, collaborating with Business Area Training Leads, Coordinators and SMEs to support cGMP and site training initiatives, reporting to the Validation Section Manager and summarizing data into concise reports for review and approval.

What you'll need

• A bachelor's degree with any years of experience, or an Associate's degree with 4 years of relevant experience, or a high school diploma (or equivalent) and 6 years of relevant experience.
• 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.

Nice to have

• 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 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.

Details

• Work location assignment: On Premise.