Sr. Engineering Validation Associate
PfizerAbout the role
Use Your Power for Purpose
Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our innovative, flexible, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care.
What You Will Achieve
In this role, you will:
Execute work independently, work with various groups across the organization, and be able to oversee and lead projects to ensure cGMP automated systems perform as intended.
Evaluate, review, and approve validation master plans, protocols, and reports, ensuring compliance with company standards and regulatory requirements.
Troubleshoot validation issues for equipment and performance processes, providing expertise for resolution.
Provide commissioning, qualification, and verification support for all cGMP automated systems at the Sanford site, related to the manufacture of biological drug substances and drug substances intermediates.
Contribute to moderately complex projects, manage time effectively, and develop plans for short-term work activities.
Manage routine Quality systems such as Change Control, Quality Agreement, Documentation, and Investigations, and coordinate testing with functional groups.
Maintain the Site Validation Master Plan, support regulatory audits, and represent engineering validation on site or network teams.
Support product transfers, new product development, regulatory queries, cost improvement projects, and Cleaning Validation, ensuring integration of validation schedules in production and participating in deviation investigations.
Here Is What You Need (Minimum Requirements)
Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience;
OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experienceProven expertise in Good Manufacturing Practices
Strong working knowledge of various quality systems and processes
Familiarity with information systems such as Global Document Management System, System Application & Products, and Quality Tracking System
Excellent verbal and written communication skills
Ability to work independently and in a team environment
Bonus Points If You Have (Preferred Requirements)
Strong technical knowledge with validation/qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems
Experience with sterile products and medical devices
Strong analytical and problem-solving skills
Strong organizational and time management skills
Ability to mentor and guide other colleagues
Experience in regulatory audits and compliance
OTHER JOB DETAILS
Last Date to Apply for Job: October 23, 2025.
Referral Bonus Eligibility: YES
Eligible for Relocation Package: NO
Work Location Assignment: On Premise
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to fu
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