Process Engineer

Pfizer • Kalamazoo, MI

9d • Onsite

About The Position

This position is for a Subject Matter Expert (SME) for Lyophilization (also referred to as Freeze Dry or Lyo) operations. The scope of the role includes support of Lyophilization related capital projects and operational support of existing Lyophilization operations. Key accountabilities include ensuring that the existing lyophilizers are functioning at an optimal state and that all new lyophilizers or modified lyophilizers function as intended to successfully manufacture drug products on schedule, ensuring all product is produced in a manner meeting safety and quality requirements.

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
• Effective verbal and written communication skills
• Proficiency in MS Office programs
• Strong organizational skills
• Basic understanding of manufacturing processes
• Pharmaceutical or manufacturing experience and strong, demonstrated project management skills exhibited in a cGMP environment are requirements.
• Specific knowledge of and experience with Drug Product processing and equipment is highly desirable.
• Successful candidate must be familiar with tools and techniques required to manage large scale complex projects through multi-disciplinary teams.

Nice To Haves

• 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
• Manufacturing experience with lyophilization equipment or unit operations common to lyophilization (wet/dry vacuum pumps, mechanical cooling, liquid nitrogen cooling, heat exchangers, and process control systems)

Responsibilities

• Serves as subject matter expert on lyophilizer and/or automated loading/unloading systems.
• Serves as responsible person for functionality of the lyophilization equipment, interfaces closely with operators, freeze dry leadership, maintenance, automation, and quality to ensure the lyophilizers are functioning as intended.
• Identifies and implements technical improvement projects aimed at defect reduction, improved equipment reliability, and better equipment utilization.
• Identifies and implements cost savings ideas, specifically efficiency improvements and other projects that increase equipment capacity.
• Identifies and implements safety improvement ideas and projects.
• Investigates deviations that arise during lyo cycles.
• Performs root-cause analysis 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.
• Able to review lyo data trends to determine level of functionality of the equipment and processes to ensure all validated criteria are met and equipment is performing at optimal levels.

Benefits

• eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% of the base salary
• 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
• health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees