Apply on Employer Site

Pfizer · 23 hours ago

Sr Process Engineer

United States - Michigan - Kalamazoo

Full-time

Onsite

Mid, Senior Level

$83K/yr - $134K/yr

6+ years exp

Pfizer is a global pharmaceutical company dedicated to improving health outcomes. They are seeking a Senior Process Engineer to conduct tests and measurements in production, investigate complex deviations, and lead technical improvement projects to enhance manufacturing processes.

BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

No H1B

Responsibilities

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

Investigates deviations of high complexity, involving multiple departments, with significant scope 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 and divisional 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

Leads technical improvement projects aimed at defect reduction, improved equipment reliability, and better equipment utilization, and may use Six Sigma tools to investigate common cause process variation

Responsible for training operations colleagues on aspects of equipment operation

Identifies and implements cost savings ideas, specifically efficiency improvements and other projects that increase equipment capacity

Develops and validates 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

Responsible for audit preparation, documentation, follow up for unit operations. Present investigations, procedures or practices to auditors, and acts as an SME for tours and discussions. 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

Participates in network or industry communities of practice to evaluate emerging technologies and best practices

May serve as a key site technical SME for specific unit operations or technologies

Qualification

CGMP knowledgeProcess validationSix Sigma toolsLean ManufacturingData analysisProject managementTroubleshootingAI tools proficiencyCommunication skillsOrganizational skillsTeamworkAttention to detailMentoringAdaptability

Required

High school diploma (or equivalent) with 8+ years of experience or associate's degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience

Strong understanding of cGMP and regulatory requirements

Proficiency in troubleshooting and problem-solving within a manufacturing environment

Excellent communication and organizational skills

Ability to work independently and as part of a team

Experience with process validation and documentation

Familiarity with environmental, health, and safety standards

Preferred

Experience in a pharmaceutical manufacturing environment

Knowledge of Lean Manufacturing principles

Proficiency in data analysis and statistical tools

Strong project management skills

Ability to mentor and train junior colleagues

Experience with regulatory inspections and audits

Strong attention to detail and commitment to quality

Ability to adapt to changing priorities and work in a fast-paced environment

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