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

Posted:
9/16/2024, 7:47:16 AM

Location(s):
Rochester, Michigan, United States ⋅ Michigan, United States

Experience Level(s):
Junior ⋅ Mid Level

Field(s):
IT & Security

Why Patients Need You

Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what’s possible and taking action.

What You Will Achieve

Working with Pfizer’s dynamic engineering team, you will play a critical part in provides technical or business support to engineers on a variety of technical tasks. Your documentation skills will come in handy to prepare engineering documentation, reports and drawings. You will be conducting preliminary analysis of trajectory adequacy data, model dimensional consistency and quantitative judgements concerning technical data. You will also support the team by conducting tests and recording data to assist engineering evaluations.

You will be a team member who is relied to have a good understanding of procedures, techniques, tools, materials and equipment. Your decision making will help you prioritize workflows based on the available resources. You will follow standard procedures to complete tasks, some of which may vary in scope, sequence, complexity and timing. You will contribute to the team’s success by sharing your previously acquired knowledge.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.


The essential duties for this position include but are not limited to:


• 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.

How You Will Achieve It

  • Accountable for own results and prioritizes workflow based on needs.

  • Coordinate with maintenance to complete repairs and develop solutions to equipment issues.

  • Perform all tasks as outlined in batch records, procedures, and job aids.

  • Assemble, operate, clean and troubleshoot micronizing, formulation and aseptic filling equipment.

  • Manage own time and professional development.

Qualifications

Must-Have

  • High School Diploma or GED

  • 2+ years of experience

  • Understands basic problem solving methods.

  • Mathematics and reading skills required for SOP, Good Manufacturing Practices {also cGMP} and Batch Record comprehension

Physical/Mental Requirements

  • This position is in a Penicillin Facility. The candidate cannot be allergic to Penicillin, and will be required to undergo Penicillin allergy testing.

  • This department requires the SMO to bend, reach, lift and stand for extended periods of time.

  • The SMO must be able to grasp from 4 – 5 filled syringes at a time in one hand while manipulating them with the other hand for overall evaluation for defects.

  • All SMOs must have corrected 20/20 vision and must be able to pass a routine inspection test using seeded syringes.

  • Good skills in communication and leadership

  • Ability to contribute to department success in a team environment

  • Performs tasks at a productive level under demanding conditions is mandatory

Non-Standard Work Schedule, Travel, or Environment Requirements

  • The Penicillin Inspection/Packaging department is currently operating on a one-shift basis, five days per week. However, SMOs must be available for extended hours and six to seven day operations, if required in order to maintain the required delivery schedule, overtime may be required. 

  • This is a Collective Barging Agreement (Union) position.

  • The work schedule is 7am to 3:30pm with overtime as needed.

Other job details

  • Last day to apply: September 30, 2024

  • Eligible for employee referral bonus: Yes.

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Work Location Assignment: On Premise

The salary for this position ranges from $0.00 to $0.00 per hour. In addition, this position offers eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company’s policies. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 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, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided applies only to the United States - Michigan - Rochester location.

Relocation assistance may be available based on business needs and/or eligibility.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations.  These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure.  Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act.  Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government.  If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.  Pfizer is an E-Verify employer.  This position requires permanent work authorization in the United States.

Engineering

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