MAP Mod 1 Filling, Freeze Dry, Capping Sr Operations Technician
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
You will monitor and respond to basic functioning needs of area equipment, i.e. line speed, feeding product, line clearances, cleaning, loading or unloading materials adhering to all SOPs, cGMPs (current Good Manufacturing Practices), plant quality, safety, and documentation systems requirements.
As part of the Technical Operations team, you are recognized as a subject matter expert with specialized knowledge and skills in procedures, techniques, tools, materials and equipment. You will be entrusted with adapting standard methods and procedures by applying your knowledge, prior work experience and requirements. Your business awareness of cross-organizational impact on project delivery will elevate the quality of project deliverables. You will arrive at decisions on which methods and procedures are the best fit for different work situations. You will assist with training others and reinforce behaviors that will help us achieve our goal of providing the best healthcare to patients.
How You Will Achieve It
- Manage own time, professional development and be accountable for own results.
- Monitor and respond to basic functioning needs of area equipment, i.e. line speed, feeding product, line clearances, loading or unloading materials.
- Establish efficient processes, monitoring results, and improve identified process opportunities using Right First Time and Lean principles.
- Enter data into PLS to ensure accurate, complete, and timely training documentation. Perform detailed inspection of commodities.
- Work with unit leadership to develop action plans to close training gaps.
- Develop solutions to routine problems following established Pfizer policies and procedures.
- Prioritize own workflow and allocate work to others and assist in establishing their priorities.
ROLE OVERVIEW
The MAP Mod1 Sr Operations Technician 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 Sr Techs may specialize in one specific area (i.e., filling, freeze dry, or capping), they will be required to cross train and perform work in other processing steps run in that unit.
This job includes the following functions:
Setting up and changing over the production equipment per approved procedures
Monitoring production for efficient run time versus established standards
Processing of hazardous and non-hazardous drug products into final containers
Routine cleaning and sanitization
Ensuring adequate inventory of parts and materials prior to initiating a production run
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, and learning filling principles
Working safely and compliantly following all applicable SOPs and standards including recording of GMP documentation
Achieving and maintaining aseptic 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 verifications and sampling
Working in other areas if required
Leadership and contributing to growth of IMEx process.
Other duties as assigned by the supervisor
ROLE RESPONSIBILITIES Overview: As the upper-level role in this career path, the colleague is expected be proficient at all requirements of the Operations Technician Assistant and Operations Technician role as well as the following:
EHS
Performs non-routine LOTO
Safety self-inspections (works toward eliminating deficiencies)
GMP
GMP record entries (minimal errors maintained)
Excellent Aseptic Behavior (minimal PM hits)
Suggests / implements unit corrective actions
Maintains Working Areas Audit Ready (GMP/5S) – works toward resolving deficiencies
Filling Operations
SME for all computer-based systems/programs used in operations.
Able to provide SME guidance in troubleshooting and adjusting all equipment
SME for line changeovers/setups, Ability to troubleshoot and escalate issues accordingly
Technician is able to assist Operations Specialist and Maintenance during troubleshooting activities
Performs daily & non-daily processes with high level of proficiency
Proficient in Advanced Alarm response
Handoffs (maintains equipment status through the shift)
Able to provide end of shift handoff
Maintains Working Areas Audit Ready – works toward resolving deficiencies
Complete Scheduled Operator Care activities - works toward resolving deficiencies
Production planning / Scheduling expertise (work with other units for schedule adjustment; able to explain others)
Perform Lead Operator duties - Lead backup
Effective communication with peers and upstream and downstream units
Support/lead investigations and document updates
Other:
Participates in Operational Excellence projects (required)
(i.e. Yellow / Green / Black Belt / 5S / Standard Work)
Identify / implement improvements - safety, process, cost, efficiency, Zero Defects
Proactively trains others (help manage training progression of newer colleagues)
Proactively acts as coach/mentor to peers
Provides support for Unit, Division, and Site initiatives and policies within the unit to peers
QUALIFICATIONS
Education and Experience:
High school diploma / general education degree (GED) plus
60 months as an Operations Technician, OR
9+ years of relevant GMP experience in an aseptic environment (e.g. filling, manufacturing, prep, or similar)
Mechanical experience / knowledge preferred.
PHYSICAL/MENTAL REQUIREMENTS
Physical Demands:lifting/lowering up to 55 pounds, working in high elevations (above 6 feet), and reaching/standing/walking/stooping/repetitive motion.
Able to wear safety PPE (Hard hat, body harness, face shield)
Able to work under full clean room (GRADE A/B/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.
Work Location Assignment: On Premise
The salary for this position ranges from $26.48 to $44.14 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.
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.