Validation Engineer I

Pfizer is a leading biopharmaceutical company dedicated to improving health. The Validation Engineer I role involves providing validation support for manufacturing processes and equipment, ensuring compliance with GMP standards in clinical drug substance production.ResponsibilitiesPlan and coordinate the validation work assignedGain technical understanding of process and equipment to be qualifiedPerform the work in accordance to all compliance requirements and in a safe mannerPerform temperature mapping of CTUs: Incubators, Refrigerators, Freezers, and Environmental RoomsSample various process equipment in support of the cleaning program (product changeover, cleaning monitoring, performance qualification)Support validation of chambers: Autoclaves, Glasswashers, etcPerform periodic reviews of qualified equipment ensuring that the equipment is maintained in a validated stateEnhance cleaning program by performing bench scale cleaning studies of incoming process soils to establish carryover limits and HBELsSkillsApplicant 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 experienceExperience in a GMP biotechnology manufacturing or laboratory environmentAbility to execute against Standard Operating Procedures and document entries in a compliant mannerDemonstrated capability to work as a team member in a matrix development teamStrong analytical and computer skillsExcellent oral and written communication skillsAbility to maintain a safe work environmentExperience working in a large-scale manufacturing facilityPrevious experience with cleaning validation and/or temperature mappingExperience with facility/equipment commissioning and qualificationFamiliarity with creating essential cGMP documentationCommitment to continuous improvement and operational excellenceExperience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivityBenefitsParticipation in Pfizer’s Global Performance Plan with a bonus target of 7.5% of the base salary401(k) plan with Pfizer Matching ContributionsAdditional Pfizer Retirement Savings ContributionPaid vacationHoliday and personal daysPaid caregiver/parental and medical leaveHealth benefits to include medical, prescription drug, dental and vision coverageCompany OverviewPfizer is a biopharmaceutical company that discovers, develops, and delivers medicines and vaccines. It was founded in 1849, and is headquartered in New York, New York, USA, with a workforce of 10001+ employees. Its website is http://www.pfizer.com.



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