MAP Mod 1 Prep/Mfg Operations Technician Assistant (1st Shift)
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 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 Mod1Technician Assistant role is responsible for supporting the production of injectable drug products in the Modular Aseptic Processing (MAP) Mod 1 Facility Prep, Manufacturing and Tank Assembly unit. Although Tech Assistants may specialize in one area (i.e. prep, mfg, or tank assembly), 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:
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
QUALIFICATIONS
Education and Experience:
- High School Diploma or GED
- 2+ years of experience
- Demonstrates ability to properly problem solve work-related issues, exercise good judgement/decision making, and effectively work with team members.
In addition, the following skills are preferred:
Mechanical experience/aptitude
Experience handling biologic substances, APIs, or drug products
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
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.
OTHER JOB DETAILS
Last Date to Apply for Job: 1/2/2024
Work Location Assignment:On Premise
The salary for this position ranges from $19.65 to $32.74 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.
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.