AOV Production Lead I

Pfizer•Kalamazoo, MI
•Onsite

About The Position

The Production Lead I provides leadership and direction to meet production demands across Drug Product Operations, including formulation, filling, freeze dry, packaging, inspection, aseptic services, biological operations, and other manufacturing units. The role serves as a liaison between shop floor operators, unit leadership, and cross-functional partners to support safe, compliant, and efficient operations. It models GMP behaviors, ownership, and teamwork while ensuring production activities meet regulatory, safety, quality, and business requirements. The position leads day-to-day manufacturing operations, supports troubleshooting and investigations, monitors and improves processes and equipment, and coordinates resources to meet production commitments. It also supports training, audits, capital projects, new product introductions, equipment qualification, documentation, and continuous improvement initiatives. This is an onsite role supporting 24/7 manufacturing operations. Shift assignment may vary and may include nights, weekends, holidays, overtime, and nonstandard schedules. The stated third shift is 9:30 PM–6:30 AM. Work takes place in manufacturing, cleanroom (Grade A/B/C/D), and office environments, with required gowning and PPE. Physical work may include lifting and lowering up to 55 pounds, standing, walking, sitting, climbing, reaching, stooping, and working at elevated heights. Potential exposures include noise, moving equipment, solvents, pharmaceutical ingredients, and electromagnetic fields.

Requirements

  • High school diploma or GED.
  • At least 4 years of experience.
  • Proficiency in Good Manufacturing Practices (GMP) and related systems.
  • Ability to troubleshoot and resolve technical issues.
  • Strong organizational skills and attention to detail.
  • Ability to work independently and as part of a team.
  • Ability to adapt to changing priorities and manage multiple tasks.
  • Ability to communicate effectively across departments and follow written and verbal instructions.
  • Ability to meet the role’s physical requirements, including lifting and lowering up to 55 pounds and standing, walking, sitting, climbing, reaching, stooping, and working at elevated heights.
  • Flexibility, attention to detail, sound judgment, and ability to respond effectively to changing operational conditions while maintaining compliance and safety standards.
  • Permanent work authorization in the United States; U.S. work visa sponsorship is not available.

Nice To Haves

  • Experience in pharmaceutical manufacturing or a related field.
  • Knowledge of regulatory requirements and quality standards (cGMP).
  • Experience with Lean Manufacturing principles.
  • Familiarity with Pfizer's Learning Solution and Quality Tracking System.
  • Ability to train and mentor less-experienced colleagues.
  • Familiarity with common AI tools and curiosity about using them to enhance productivity.

Responsibilities

  • Lead day-to-day manufacturing operations to meet production schedules while ensuring compliance with SOPs, GMPs, OSHA, and Pfizer standards.
  • Liaise among operations, maintenance, technical support, logistics, planning, and management to resolve production issues and adjust plans as needed.
  • Monitor, evaluate, and improve manufacturing processes and equipment using IMEx, Right First Time (RFT), Method 1, 5S, Lean, and Continuous Improvement principles.
  • Provide shop-floor technical expertise and support troubleshooting, investigations (M1s, QARs, deviations), and root cause analysis.
  • Support training compliance by ensuring team members are trained and qualified; mentor and develop colleagues and provide feedback to leadership.
  • Represent the operations area in audits, capital projects, new product introductions, equipment qualification activities (IQ/OQ/PQ, FAT/SAT), and continuous improvement initiatives.
  • Partner with planning to allocate manpower and resources to meet production commitments and respond to changing business priorities.
  • Maintain accurate documentation, generate work orders and reports, and ensure audit readiness.
  • Communicate effectively with production teams and leadership and model Pfizer values and leadership behaviors.

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.
  • Medical, prescription drug, dental, and vision coverage.
  • Eligibility for overtime, weekend, holiday, and other pay premiums depending on work schedule and company policies.
  • Relocation assistance may be available based on business needs and/or eligibility.
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