U-05 Sterile Manufacturing Operator B (1st shift)

Pfizer • Rochester, MI

1d • $27 - $0 • Onsite

About The Position

This role is crucial for Pfizer's mission of improving patients' lives by ensuring the timely delivery of essential medicines. The Sterile Manufacturing Operator B will provide technical and business support to engineers, prepare engineering documentation, and conduct preliminary analyses. The position requires adherence to standard procedures, problem-solving, and effective teamwork. The operator will perform tasks related to inspecting filled syringes, manual packaging, and maintaining a clean work area, all while strictly observing SOPs and safety regulations. This role is in a Penicillin Facility, requiring the candidate to not be allergic to Penicillin and undergo testing. The department operates on a single shift basis but requires availability for extended hours and weekend operations if needed.

Requirements

• High School Diploma or GED with 2+ years of experience
• Understanding basic problem-solving methods, mathematics, and reading skills
• Good Manufacturing Practices (also cGMP) and Batch Record comprehension
• Strong communication and leadership skills
• Ability to contribute to department success in a team environment
• Performing tasks at a productive level under demanding conditions
• Solid understanding of procedures, techniques, tools, materials, and equipment
• Cannot be allergic to Penicillin and will be required to undergo Penicillin allergy testing.
• Must have corrected 20/20 vision and must be able to pass a routine inspection test using seeded syringes.
• 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

• Experience in a pharmaceutical or manufacturing environment
• Proficiency in engineering software and tools
• Knowledge of regulatory requirements and quality standards
• Strong analytical and problem-solving skills
• Excellent organizational and time management skills
• Demonstrated ability to prioritize tasks and manage multiple projects simultaneously
• Familiarity and basic understanding of common AI tools and a curiosity for learning how they can be used to enhance productivity

Responsibilities

• Provide technical and business support to engineers on various tasks.
• Prepare detailed engineering documentation, reports, and drawings.
• Conduct preliminary analyses of trajectory adequacy data and ensure model dimensional consistency.
• Make quantitative judgments on technical data and conduct tests to assist in engineering evaluations.
• Take responsibility for individual contributions to achieve team deliverables, working effectively as a team member and coordinating with others.
• Manage personal time and professional development, being accountable for results.
• Follow standard procedures to complete tasks of varying scope, sequence, and complexity within the agreed timeframe.
• Identify and solve moderately routine problems.
• Complete assignments with moderate supervision using established procedures, referring deviations from standard procedures to the supervisor.
• Ensure work is reviewed for accuracy, quality, and adherence to standards.
• Performs all tasks as outlined in the Batch Card, SOPs, and/or Job Aids.
• Inspects filled syringes to established criteria and sorts defects into the appropriate receptacle for reconciliation.
• Performs manual packaging operations as assigned by the supervisor according to the appropriate SOP or Job Aid.
• Observes all SOPs and Safety and Health Regulations.
• Re-stocks packaging supplies from line stock as required to maintain packaging operation.
• Notifies supervisor, PMO and/or Quality Specialist of unusual or recurring defects in syringe products or packaging materials.
• Maintains work area in a clean and orderly manner.
• Assists in training new colleagues as required.
• Verifies packaging supplies and product against product board or Batch Card to assure correctness.
• Signs pertinent forms as required.
• Participates in all required training programs to maintain required level of cGMP compliance.
• Performs off-line inspection of product, such as media reading, as required.
• Performs other miscellaneous duties as assigned by supervisor.

Benefits

• 401(k) plan with Pfizer Matching Contributions
• 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
• Eligibility for overtime, weekend, holiday and other pay premiums

What This Job Offers

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