AOV Operations Specialist I

Pfizer • Kalamazoo, MI

1d • Onsite

About The Position

The AOV Filling Operations Specialist I provides technical training to Drug Product work team colleagues and serves as a liaison between the work team and maintenance for repairs and preventative maintenance. The role develops, maintains, and trains colleagues on operator care task sheets; improves processes using Right First Time and Lean principles; and helps maintain manufacturing equipment at optimal operating efficiency. The specialist helps identify problems and solutions using Method 1 and Quality Risk Management, serves as a technical subject matter expert for the work team, and coordinates equipment-related deviation reports.

The role works with engineering on equipment specifications, user requirements, capital scope development, factory and site acceptance testing support, and qualification activities. It also works with procurement and filling engineering to monitor component issues and conduct feasibility assessments and line trials. As directed by supervision, responsibilities may include day-to-day floor operations, line assignments, acting as person in charge when a Production Lead or Supervisor is absent, attending scheduling meetings, completing shift reports, writing QARs and PTVAs, working with OEE, and reviewing and requesting SOP and document revisions.

The position requires entry into the aseptic area and aseptic gowning. It is an on-premise, third-shift role in Kalamazoo, Michigan, with a schedule of 9:30 PM to 6:30 AM. Overtime, weekends, and holidays may be required as necessary.

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.
• Effective written and oral communication skills, reading comprehension, and writing proficiency appropriate to the job.
• Strong math skills, including calculating percentages and developing basic graphs and spreadsheets.
• Ability to analyze information, problems, situations, practices, or procedures; identify relevant factors and patterns; formulate logical conclusions; and recognize alternatives and their implications.
• Ability to work overtime, weekends, and holidays as necessary.
• Ability to meet the physical demands of the job, including frequent bending, lifting, and twisting and standing upright for several consecutive hours.
• No medical restrictions that would prevent completion of required duties.
• Must be authorized to work in the United States; permanent U.S. work authorization is required. U.S. work visa sponsorship is not available.

Nice To Haves

• Experience with Lean Manufacturing principles.
• Knowledge of regulatory requirements and quality standards.
• Familiarity with Pfizer's Learning Solution and Quality Tracking System.
• Ability to train and mentor less-experienced colleagues.
• Familiarity with and basic understanding of common AI tools, and curiosity about using them to enhance productivity.

Responsibilities

• Provide detailed technical training to Drug Product work team colleagues.
• Liaise between the work team and maintenance for repairs and preventative maintenance.
• Develop, maintain, and train work team colleagues on operator care task sheets.
• Establish efficient processes, monitor results, and improve identified opportunities using Right First Time and Lean principles.
• Maintain manufacturing equipment at optimal operating efficiency.
• Assist in identifying problems and solutions using Method 1 and Quality Risk Management.
• Serve as the work team’s technical subject matter expert and as Deviation Report Coordinator for equipment-related deviations.
• Collaborate with engineering on equipment specifications, user requirements, capital scope development, FAT/SAT support, and qualification activities.
• Work with procurement and filling engineering to monitor component issues and conduct feasibility assessments and line trials as needed.
• As directed, support day-to-day floor operations and daily line assignments.
• Serve as person in charge when a Production Lead or Supervisor is absent, as directed.
• Attend scheduling meetings and complete the daily shift report.
• Write QARs and PTVAs, work with OEE, and review and request SOP and document revisions.
• Follow area-specific safety requirements and aseptic gowning requirements when working in the aseptic area.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED