Sterile Manufacturing Operator

PfizerRochester, MI
Onsite

About The Position

Use Your Power for Purpose At Pfizer, we believe that every role contributes to our mission of improving patients' lives. Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is crucial to ensuring customers and patients receive the medicines they need, precisely when they need them. By collaborating with our forward-thinking engineering team, you'll play a pivotal role in accelerating the delivery of medicines to the world. In this role, you will: 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.

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
  • Candidate cannot be allergic to Penicillin, and will be required to undergo Penicillin allergy testing.
  • Must have corrected 20/20 vision including color and must be able to pass a routine inspection test using seeded syringes.
  • 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

  • Performs all tasks as outlined in the Batch Card, SOPs, and/or Job Aids.
  • Effectively demonstrates and understands the SOPs and Job Aids pertinent to all assigned tasks.
  • 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.
  • If 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.
  • Relocation assistance may be available based on business needs and/or eligibility.
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