​​MAP Mod 1 Filling/FD/Capping Operations Technician Assistant​ (1st Shift)

Pfizer Inc.

Kalamazoo, MI

Job posting number: #7230642 (Ref:pf-4908427)

Posted: March 21, 2024

Job Description

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

As part of technical operations, you will be a team member who is relied on 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 help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

  • Manage own time and professional development, be accountable for own results and begin to prioritize own workflow.
  • Responsible for the preparation and/or operation of various components, materials, equipment, machines including, but not limited to any and/or all applicable components, materials, equipment, machines in the assigned area(s).
  • Complete adherence to all plant safety and (current) Good Manufacturing Practices {also cGMP} regulations to the highest.
  • Assist with diagnosis and troubleshooting activities and execute in-process quality inspections.
  • Ensure adequate inventory of parts and materials prior to initiating a production run.
  • Identify and seek to implement process and safety improvement and perform all tasks in a safe manner.
  • Participate in shift meetings, provide hand off information and communicate with other units and shifts.

ROLE OVERVIEW 

The MAP Mod1 Technician Assistant role is responsible for supporting the production of injectable drug products in the Modular Aseptic Processing (MAP) Mod 1 facility Filling, Freeze Dry and Capping unit.  Although Tech Assistants may specialize in one area (i.e. filling, freeze dry, capping), they will be required to cross train and perform work in other processing steps run in that unit.  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: 

  • Performing unit operations in the formulation area with a variety of production 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 

  • Completing and maintaining all required training on time 

  • Demonstrating ownership and accountability of the production schedule and product quality 

  • Executing in-process quality inspections  

  • Learning and contributing to IMEx activities. 

  • Other duties as assigned by the supervisor. 

 

ROLE RESPONSIBILITIES  

Overview: As the entry level role in this career path, the colleague is expected to show progression towards all the items below and competency on a growing number of them as the duration in the role progresses. 

 

EHS  

  • Safety Orientation &Safety OJT training 

  • LOTO / Safe work permits / Confined space Awareness  

  • Unit safety self-inspections  

 

GMP  

  • GMP record entries   

  • Gowning access (Certification completed)  

  • Meets daily GMP requirements - with assistance   

  • Maintains training documentation (PLS & Curricula)  

  • Alarm response & notification awareness  

 

OPERATIONS  

  • All process steps and unit operations (with assistance) 

  • Setting up and operating formulation equipment (with assistance) 

  • Monitoring process performance and making appropriate documentation entries 

  • Weighing and charging operations with biological materials 

  • Perform specific and accurate double checks 

  • Maintain area audit readiness 

  • Display cGMP’s at all times 

  • Identify issues, respond, and escalate appropriately 

  • Complete and accurate handoffs  

  • Operator care activities  

  • Facility cleaning for routine and special cause events 

  • Batch record review  

 

Other:  

  • Practices leader behaviors in accordance with Pfizer Core Values including: Seizes Accountability, Grows Self, Adapt to Change, Self Awareness, Commits to One Pfizer, and Peer Relationships 

  • Performs work in professional, self-directed, responsible, and timely manner  

 

Qualifications

Must-Have

  • High School Diploma or GED
  • 2+ years of experience
  • Demonstrates ability to properly problem solve work-related issues, exercise good judgment/decision making, and effectively work with team members

Nice-to-Have

  • Bachelor's Degree
  • Previous experience in cGMPs (current Good Manufacturing Practices) environment

 

PHYSICAL/MENTAL REQUIREMENTS

Physical Demands: 

  • 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. 

 

Weekends, holidays, and overtime may be required to meet business or customer needs.

Relocation support available
Work Location Assignment: On Premise

The salary for this position ranges from $20.33 to $33.89 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

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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.


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