MAP Mod 1 Filling/FD/Capping 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 be responsible for generating work orders and ensuring that work is completed correctly in a timely manner. Your knowledge in the domain will help in providing detailed technical training to colleagues. You will support the work team operation to ensure that applicable safety guidelines/policies are followed, and that all tasks are conducted in accordance with appropriate processing standards, such as current Good Manufacturing Practices (cGMPs).
As part of the Technical Operations team, your prior work experience and ability to apply your breadth of knowledge will help you adapt the standard methods and procedures. You will help us identify required delivery and process improvements that drive increased efficiency, throughput and quality. You will arrive at decisions on which methods and procedures are the best fit for different work situations.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
- Manage own time, professional development and be accountable for own results.
- Prioritize own workflow and assist in prioritizing the workflow of less-experienced colleagues.
- Keep accurate records as needed for solution manufacture and prepare solutions as directed by work order.
- Recognize when processes, procedures, equipment, product, commodities, etc. are out of specifications.
- Check improper use or monitoring of equipment that may result in substantial downtime, equipment and material or product loss.
- Support supervisor to execute investigations, analyze process data and identify and implement process improvements.
- Prepare regular reports and metrics from Pfizer's Learning Solution and Quality Tracking System to identify training needs and progress with the unit.
ROLE OVERVIEW
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
QUALIFICATIONS
Education and Experience:
High school diploma / general education degree (GED) plus
24 months as an Operations Technician Assistant, OR
48+ months of relevant GMP experience in a classified environment (e.g. freeze dry, mfg, prep, or similar)
In addition, the following skills are preferred:
Mechanical experience/aptitude
Experience handling biologic substances, APIs, or drug products
ROLE RESPONSIBILITIES
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
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.
OTHER JOB DETAILS
Last Date to Apply for Job: 1/2/202
Work Location Assignment: On Premise
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.
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