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Process Technician 1 (2nd Shift)

Employer
Pfizer
Location
Kalamazoo, Michigan
Start date
Sep 26, 2022

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***Pfizer now offering ***** sign-on bonus for successful hire through December 31st***

Schedule Subject to Change

ROLE OVERVIEW

The Biological Operations Tech role is responsible for processing raw materials (i.e. human and equine blood and plasma) into Stroma to be used in the formulation of ATGAM Purified Drug Substance by means of a large-scale biologic separation processes (i.e. centrifugation). Techs may also perform work on other processing steps related to other products 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:

  • Performing unit operations in the biological processing area with a variety of different equipment types (tanks, pumps, centrifuges, scales, filters, freeze dryers, etc.)

  • Washing, sanitizingand cleaning facilities and equipment

  • Handling, Charging and packaging materials

  • Monitoring process parameters and batch end reportsfor quality or equipment concerns

  • Utilizingcomputer skills to interact with multiple complex PLC and SCADA systems

  • Collaboratingwith maintenance and engineers totroubleshootequipment and perform TPM tasks

  • Supportingdevelopment andexecution of capital projects, corrective actions, and continuous improvement ideas

  • Demonstratinggrowth mindset to share best practices & utilize downtime effectively

  • Workingsafely and compliantly following all applicable SOPs and standards including recording of GMP documentation

  • Completing and maintaining all required training on time

  • Demonstrating ownership and accountabilityof theproduction schedule and product quality

  • Executing in-process quality inspections

  • Other duties as assigned by the supervisor

ROLE RESPONSIBILITIES

Overview: As the entry levelrole 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 

BIOLOGICAL OPERATIONS 

  • Stroma process and Blood Room operations (with assistance)

  • Setting up and operating biological operations equipment (with assistance)

  • Monitoring process performance and making appropriate documentation entries

  • Weighing and charging operations with biological materials

  • Perform specific and accurate double checks

  • Can perform disposals

  • Weekend Rotation (participation) 

  • Maintain area audit readiness

  • Display cGMP’s at all times

  • Identify issues, respond, and escalate appropriately

  • Complete andaccuratehandoffs

  • Operatorcare activities 

  • Facility cleaning for routine and special cause events

  • Batchrecordreview 

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 

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 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.

QUALIFICATIONS

Education and Experience:

  • High school diploma / general education degree (GED) plus

  • An associate degree, OR

  • Veteran/Military experience, OR

  • Six months of relevant work experience in a manufacturing or GMP facility (e.g. current or previous Pfizer colleague or contractor or similar)

In addition, the following skills are preferred:

  • Mechanical experience/aptitude

  • Experience handling biologic substances, APIs, or drug products


Work Location Assignment:On Premise

PHYSICAL/MENTAL REQUIREMENTS

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

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Positions are staffed across all three shifts. Specific shift schedules may vary by specific operational area. Weekend, holiday, and overtime may be required to meet business or customer needs.

Last Date to Apply for Job: September 16th, 2022
Eligible for Relocation Package: NO
Eligible for Employee Referral Bonus: YES
#LI-PFE

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

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

Manufacturing

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