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Pfizer · 15 hours ago

Process Engineer

United States - Michigan - Kalamazoo

Full-time

Onsite

Entry, Mid Level

4+ years exp

Pfizer is a leading pharmaceutical company dedicated to improving patient outcomes through its manufacturing team. The Process Engineer role involves conducting tests, investigating production deviations, and supporting safety initiatives to ensure compliance and efficiency in the manufacturing process.

BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

No H1B

Responsibilities

Conducts tests and measurements throughout stages of production to determine control over applicable variables

Investigates deviations of medium complexity, involving multiple departments that occur on the manufacturing floor. Performs root-cause analysis utilizing Six Sigma tools, and identifies appropriate, effective corrective actions. Implements corrective actions in conjunction with the appropriate enabling groups, i.e. engineering, maintenance, quality, validation, environmental health and safety

Authors and performs periodic reviews of unit documentation, including SOPs, User Guides, Job Aids, etc., and gathers input from cross-functional team members to ensure safe, efficient, and compliant practices

Supports safety team by proactively identifying improvement opportunities and implementing engineering, protective, and procedural controls to improve the safety of colleagues working in the area and ensure compliance with applicable regulations

Participates in (may lead) technical improvement projects aimed at defect reduction, improved equipment reliability, and better equipment utilization

Responsible for training operations colleagues on aspects of equipment operation

May assist in identifying and implementing cost savings ideas, specifically efficiency improvements and other projects that increase equipment capacity

May develop and validate manufacturing processes for drug products, taking into consideration problems inherent in the transfer of technology from research to production, from other sites, or within the site

Contributes to regulatory audits by assisting in preparation, documentation, follow up, and by working in audit support room. May present investigations, procedures or practices to auditors. Participates in developing compliance gap assessments and responses for Pfizer Quality Standards or for Regulatory Observation Network Assessments

Contributes to master planning exercises by maintaining matrices of unit capabilities, gaps, and needs

Qualification

Pharmaceutical experienceCGMP knowledgeRegulatory standardsSix Sigma toolsManufacturing processesCost-effective solutionsProblem-solving skillsMS Office proficiencyAI tools experienceOrganizational skillsVerbal communicationWritten communication

Required

BA/BS degree with any years of experience, or Associate's degree with 4+ years of experience, or high school diploma (or equivalent) with 6+ years of relevant experience

Effective verbal and written communication skills

Proficiency in MS Office programs

Strong organizational skills

Basic understanding of manufacturing processes

Preferred

Pharmaceutical experience in Operations Engineering

Experience in a highly regulated environment

Knowledge of cGMP and regulatory standards

Strong problem-solving skills

Ability to identify and implement cost-effective solutions

Experience in optimizing production workflows

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