MAP Freeze Dry Sr Process Engineer

Pfizer • Kalamazoo, MI

3h • 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 startup, commissioning, qualification and operational support of MAP MOD 1 Freeze Dryers (4). Key accountabilities include ensuring that the lyophilizers are functioning at an optimal state and that all function as intended to successfully manufacture drug products per the current project schedule schedule (PPQ’s 4th Q 2027), ensuring all product is produced in a manner meeting safety and quality requirements. Provides technical expertise and operational support for Modular Aseptic Processing (MAP) Freeze Dry operation. This position partners with shop floor colleagues and supervision to ensure smooth and efficient production of a diverse mix of human health injectable products. Assists in equipment troubleshooting activities as needed. Work is achieved by individual or through project teams, utilizing technical or subject matter expertise to achieve results. Requires relevant scientific education, skills, and knowledge.

Requirements

• Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience.
• Requires strong understanding of the principles of the discipline and applies these skills and departmental knowledge to achieve assigned work.
• Begins to apply experimentation and use of new ideas.
• Contributes to the completely of moderately complex projects across a work team.
• Makes decisions to resolve moderately complex problems with short term impact within work team.
• Works under general supervision using own judgment where needed.
• Candidates must be authorized to be employed in the U.S. by any employer.
• This position requires permanent work authorization in the United States.

Nice To Haves

• 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.

Responsibilities

• Supports the capital project team to test and qualify equipment.
• Supports the Operations Readiness Team to ensure equipment and operators are ready for Product Validation.
• Partners with the IMEx team to support and drive Continuous Improvement initiatives.
• Identifies and implements cost savings ideas, specifically line 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.
• Conducts tests and measurements throughout stages of production to determine control over applicable variables.
• Investigates deviations that occur on the manufacturing floor.
• 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.
• Leads technical improvement projects aimed at defect reduction, improved equipment reliability, and better equipment utilization.

Benefits

• 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
• Relocation support available
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior