Validation Engineer I

Why Patients Need You 

Our breakthroughs would not make it to the hands of patients without our validation team. We rely on a team of dedicated and agile members who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. This role will provide validation support related to qualification of manufacturing processes and equipment used for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio. The validation engineer will assist in qualification activities including, but not limited to cleaning validation, equipment changeover, chamber qualification, sterilization qualification, steam quality testing, temperature mapping, and periodic review.

What You Will Achieve

As part of the Clinical Manufacturing Validation team, you will support GMP‑compliant validation activities for clinical manufacturing operations. Responsibilities include coordinating and executing validation deliverables, supporting IQ/OQ/PQ activities, managing validation schedules, and reviewing and completing validation documentation. You will work closely with Validation, Manufacturing, Quality, and SME partners to assess execution status, ensure timely completion of assigned activities, and respond to validation-related requests.

Your technical rigor, attention to detail, and continuous improvement mindset will help ensure compliant, reliable clinical manufacturing processes and support the delivery of high‑quality medicines to patients worldwide.

How You Will Achieve

• Plan and coordinate the validation work assigned

• Gain technical understanding of process and equipment to be qualified

• Perform the work in accordance to all compliance requirements and in a safe manner.

• Perform temperature mapping of CTUs: Incubators, Refrigerators, Freezers, and Environmental Rooms

• Sample various process equipment in support of the cleaning program (product changeover, cleaning monitoring, performance qualification)

• Support validation of chambers: Autoclaves, Glasswashers, etc.

• Perform periodic reviews of qualified equipment ensuring that the equipment is maintained in a validated state

• Enhance cleaning program by performing bench scale cleaning studies of incoming process soils to establish carryover limits and HBELs

Qualifications ​

Must-Have ​

• 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 a GMP biotechnology manufacturing or laboratory environment

• Ability to execute against Standard Operating Procedures and document entries in a compliant manner

• Demonstrated capability to work as a team member in a matrix development team

• Strong analytical and computer skills

• Excellent oral and written communication skills

• Ability to maintain a safe work environment

Nice-to-Have ​

• Experience working in a large-scale manufacturing facility

• Previous experience with cleaning validation and/or temperature mapping

• Experience with facility/equipment commissioning and qualification

• Familiarity with creating essential cGMP documentation

• Commitment to continuous improvement and operational excellence

• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.

PHYSICAL/MENTAL REQUIREMENTS

• Must be able to climb flights of stairs and be standing for ~1-2 hours at a time.

• Must be able to lift up to 25lb

• Must be able to complete gowning activities.

• Must be able to wear Personal Protective Equipment (PPE) to handle hazardous materials

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• This is a Monday – Friday 1st shift position (7:30am – 4:00pm).

• Ability to work off shift (Nights and Weekends) as needed; non-routine

• Ability to work in a clean room environment

Work Location Assignment: Hybrid


The annual base salary for this position ranges from $68,600.00 to $114,300.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.



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

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 further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act.  Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government.  If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.


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.

Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email [email protected]. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.


Manufacturing