AOV Operations Specialist I

Pfizer • Kalamazoo, MI

36d • Onsite

About The Position

Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members who understand the importance and impact of their role in Pfizer’s mission. You will help to ensure that patients and physicians have the medicines they need when they need them. The significance of your role cannot be overstated, as it directly influences the availability of essential medications. Your dedication and agility are crucial in maintaining the high standards of our manufacturing processes. By continuously striving for excellence, you contribute to the overall mission of delivering life-saving treatments to those in need. Your commitment to improving outcomes ensures that our breakthroughs reach the patients who depend on them. The Operations Specialist I is responsible for providing detailed technical training to Drug Product work team colleagues. Liaison between work team and maintenance for repairs and preventative maintenance. Develop, maintain and train work team colleagues on operator care task sheets. Establish efficient processes, monitoring specific results, and improve identified process opportunities using Right First Time (RFT) and Lean principles. Maintain manufacturing equipment at optimal operating efficiency. Assist in identifying problems and solutions using Method 1 and Quality Risk Management (QRM). Serve as technical subject matter expert for the work team and Deviation Report Coordinator (DRC) on equipment related deviations. Work with engineering by participating in developing equipment specifications, user requirements, capital scope development, FAT/SAT support and qualification activities. Work with procurement and packaging engineering to monitor component issues and conduct feasibility assessments/line trials as needed. What You Will Achieve Functional/Technical Knowledge: Limited knowledge of industry practices and standards. Proficient in computer applications such as MS Word, Excel and Outlook. Problem Solving and Innovation: Develop solutions to routine problems following established Pfizer policies and procedures. Discretion, Latitude, Level of Independence: Ability to work independently. Follows specific, detailed instructions. Impact and Organizational Contribution: Contributes to the completion of routine tasks. Failure to achieve results will have significant impact on departmental objectives. Time Span of Work: Daily tasks and deliverables. Results can usually be measured on daily or weekly basis. As directed by supervision, the Operations Specialist may be responsible for day to day floor operations, daily line assignments, serving as person in charge in the absence of a Production Lead and/or Supervisor, attending scheduling meetings, filling out the daily shift report, writing QAR’s, writing PTVA’s, OEE, and reviewing and requesting SOP and document revisions. Work responsibilities will require entry into the aseptic area and will include aseptic gowning requirements. Teamwork/Influence: Contacts are primarily within immediate work group or within normal process-related work flow, but interactions with other units will also be required.

Requirements

• High School Diploma or GED
• 4+ years of experience
• Strong oral and written communication skills
• Proficiency in current Good Manufacturing Practices (cGMPs)
• Experience in pharmaceutical manufacturing or a related field
• Ability to troubleshoot and resolve technical issues
• Strong organizational skills and attention to detail
• Capability to work independently and as part of a team
• Proficiency in using standard office software and manufacturing systems
• Effective written and oral communication skills required.
• Demonstrated reading comprehension and writing proficiency at level that meets Job Summary requirements.
• Ability to effectively communicate with diverse individuals/groups resulting in desired outcomes.
• Strong math skills with the ability to calculate percentages and develop basic graphs and spreadsheets.
• Skill in analyzing information, problems, situations, practices or procedures to: Define the problem or objective; Identify relevant concerns or factors; Identify patterns, tendencies and relationships; Formulate logical and objective conclusions; and, Recognize alternatives and their implications.
• Leader behaviors are an important part of this position especially teamwork, integrity, open discussion and debate, and performance.
• Leader behaviors are an integral part of the job and should be demonstrated at all times.
• Must be able to work overtime, weekends, and holidays as necessary.
• 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

• A Bachelor's Degree
• Experience with Lean Manufacturing principles
• Knowledge of regulatory requirements and quality standards
• Familiarity with Pfizer's Learning Solution and Quality Tracking System
• Ability to adapt to changing priorities and manage multiple tasks
• Ability to train and mentor less-experienced colleagues
• Familiarity and basic understanding of common AI tools and a curiosity for learning how they can be used to enhance productivity

Responsibilities

• Providing detailed technical training to Drug Product work team colleagues.
• Liaison between work team and maintenance for repairs and preventative maintenance.
• Develop, maintain and train work team colleagues on operator care task sheets.
• Establish efficient processes, monitoring specific results, and improve identified process opportunities using Right First Time (RFT) and Lean principles.
• Maintain manufacturing equipment at optimal operating efficiency.
• Assist in identifying problems and solutions using Method 1 and Quality Risk Management (QRM).
• Serve as technical subject matter expert for the work team and Deviation Report Coordinator (DRC) on equipment related deviations.
• Work with engineering by participating in developing equipment specifications, user requirements, capital scope development, FAT/SAT support and qualification activities.
• Work with procurement and packaging engineering to monitor component issues and conduct feasibility assessments/line trials as needed.
• Responsible for day to day floor operations, daily line assignments, serving as person in charge in the absence of a Production Lead and/or Supervisor, attending scheduling meetings, filling out the daily shift report, writing QAR’s, writing PTVA’s, OEE, and reviewing and requesting SOP and document revisions.
• Work responsibilities will require entry into the aseptic area and will include aseptic gowning requirements.

Benefits

• Eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company’s policies.
• 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 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