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MAP Mod 1 Operations Technician (Filling, Freeze Dry & Capping) - 1st Shift

Employer
Pfizer
Location
Kalamazoo, Michigan, United States of America
Salary
Competitive
Closing date
23 Apr 2024
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Why Patients Need You

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. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.

What You Will Achieve

The MAP Mod1 Technician role is responsible for supporting the production of injectable drug products in the Modular Aseptic Processing (MAP) Mod 1 facility in the filling, freeze dry and capping unit. Although Techs may specialize in one specific area (i.e., filling, freeze dry, capping), they will be required to cross train and perform work in other processing steps run in that area. Work is performed in strict compliance with manufacturing standards (SOPs) and following all regulatory requirements (i.e., GMPs & OSHA). This job includes the following functions:
  • Setting up and changing over the equipment per approved procedures
  • Performing unit operations in the production area with a variety of different equipment types.
  • Washing, sanitizing and cleaning facilities and equipment
  • Handling, Charging and packaging materials
  • Monitoring process parameters and batch end reports for quality or equipment concerns
  • Utilizing computer skills to interact with multiple complex PLC and SCADA systems
  • Collaborating with maintenance and engineers to troubleshoot equipment and perform TPM tasks
  • Supporting development and execution of capital projects, corrective actions, and continuous improvement ideas
  • Demonstrating growth mindset to share best practices & utilize downtime effectively
  • Working safely and compliantly following all applicable SOPs and standards including recording of GMP documentation
  • Achieving and maintaining appropriate certification to work within graded spaces
  • Completing and maintaining all required training on time
  • Demonstrating ownership and accountability of the production schedule and product quality
  • Executing in-process quality inspections
  • Developing and contributing to IMEx activities.
  • Other duties as assigned by the supervisor

How You Will Achieve It

Overview: As the mid-level role in this career path, the colleague is expected be proficient at all requirements of the Operations Technician Assistant role as well as the following:

EHS
  • Performs routine Lock Out Points
  • Initiates & completes routine Safe Work Permits
  • Unit safety facility inspections
  • Suggests or Implements safety improvements for unit (Ongoing)
GMP
  • Performs basic daily & non-daily processes without assistance
  • Performs advanced processes with minimal assistance
  • GMP record entries (complete with minimal errors)
  • Exhibits good aseptic behavior (Certifications maintained)
  • Maintains training requirements (up to date per unit goals)
  • Maintains Working Areas Audit Ready (GMP/5S)
  • Alarm response & notification awareness

DRUG PRODUCT OPERATIONS
  • Appropriately display ability to troubleshoot and adjust production equipment
  • Understanding of advanced processes
  • Equipment Functional Testing
  • Advanced Alarm response
  • Complete Scheduled Operator Care activities
  • Complete SAP / EMS entries when required
  • Complete batch record review in target time
  • Production planning / Scheduling knowledge
  • Assist with investigations and document updates
  • Provide SME guidance when needed

Other:
  • Participates in Operational Excellence projects (optional) (i.e. Yellow / Green / Black Belt / 5S / Standard Work)
  • Identifies unit improvements (i.e. safety, process, cost, efficiency, etc.)
  • Participates site programs (i.e. Safety, Zero Defects, etc.)
  • Trains others when requested

QUALIFICATIONS

Must -Have
  • High school diploma / general education degree (GED) plus
  • 2 years as an Operations Technician Assistant, OR 4 years of relevant GMP experience in a classified environment (e.g. freeze dry, mfg, prep, or similar)

Nice - to have

  • Mechanical experience/aptitude
  • Experience handling biologic substances, APIs, or drug products.
PHYSICAL/MENTAL REQUIREMENTS
  • lifting/lowering up to 55 pounds, working in high elevations (above 6 feet), and reaching/standing/walking/stooping/crawling.
  • Able to wear safety PPE (Hard hat, body harness, face shield)
  • Able to work under clean room (GRADE C/D) environments with appropriate gowning

      NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

      Our MAP operations will start on a 8 hour shift schedule. We anticipate to run our operations on 1st with some overtime. We will reassess our schedule (8 vs 12 hrs) in about 18-24 months based on business needs and prior to running 24/7.

      Relocation support available

      Work Location Assignment: On Premise

      Last Day to Apply: April 22, 2024

      The salary for this position ranges from $23.95 to $39.92 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 - Kalamazoo 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.

      Manufacturing

      #LI-PFE

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