At Pfizer, we believe that every role contributes to our mission of improving patients' lives. Whether you are involved in the design and development of manufacturing processes for products or supporting the upkeep of systems, engineering is crucial to ensuring customers and patients receive the medicines they need.
The Validation Associate 2 will support a diverse variety of qualification activities for manufacturing processes and equipment within a biopharmaceutical manufacturing facility, including shipping validation, equipment qualification, steaming and depyrogenation qualification.
This role will also provide technical support for continuous improvement projects, driving the projects to completion to support the ongoing activities within a manufacturing environment.
As a Validation Associate 2, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will make it easy to manage difficult issues and help in establishing consensus between teams.
What You Will Achieve
In this role, you will:
This position will provide support for the Validation Program and Validation projects at the Pfizer Andover site. Key responsibilities will include:
Providing support to Steaming validation, Equipment validation, and Shipping validation.
Performance of activities according to established standard operating procedures, in accordance with compliance requirements, and in a safe manner..
Planning and coordinating the validation/qualification work assigned, including Validation Plans, Validation Strategy, Requirements Specifications, Qualification protocols, and Impact / Risk Assessments.
Supporting the validation program and procedural changes that enhance safety, compliance, and overall operational efficiency.
Working with Operations, Quality, Technical, and Supply Chain groups, and other site/network groups as required assisting with establishing business and compliance requirements of equipment and processes.
Providing a technical understanding of processes and equipment to be qualified.
Maintaining inspection readiness.
Providing technical support and participating in the implementation of change controls and commitment action items.
Providing technical support and supporting ongoing investigations.
Applying technical and quality concepts, applicable guidelines of the FDA or other regulatory bodies and relevant SOPs.
Here Is What You Need (Minimum Requirements)
Applicant must have a bachelor's degree with 0+ years of experience; OR an associate's degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience.
Experience in the area of validation activities supporting manufacturing and/or development, operating in regulated environment
Experience with Pharmaceutical Validation requirements (CFR 211, ICH, Annex 15) and/or Medical Device Validation requirements (CFR 811)
Ability to work on own initiative
Effective communication skills and fluency in English
Bonus Points If You Have (Preferred Requirements)
Background in problem solving
Experience with Data Integrity principles
Project management/support in a matrixed reporting environment
Experience with the use of Enterprise systems including, but not limited to site Quality Tracking System (QTS), Laboratory Information Management System (LIMS), and Pfizer document repositories
PHYSICAL/MENTAL REQUIREMENTS
Normal sitting, standing and walking requirements to facilities and in a laboratory environment. Ability to perform mathematical calculations, scientific computation, verbal communication, and written communication.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Position is first shift Monday through Friday. Some off hour support may be required to support staff and operations.
Other Job Details:
Last day to Apply: May 5, 2026
Work Location Assignment: On Premise
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.
Sunshine Act
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
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