Sterile Prep Operator Assistant - 2nd Shift (3:00pm - 11:30pm)

Pfizer • Kalamazoo, MI

5d • Onsite

About The Position

Our breakthroughs would not make it to the hands of patients without our dedicated and agile pharmaceutical manufacturing team. We rely on 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 strive to improve outcomes. You will help ensure that patients and physicians have the medicines they need when they need them. In this role, you will: Take responsibility for individual contributions to achieve team deliverables, working effectively as a team member and coordinating with others. Manage personal time and professional development, being accountable for results. Follow standard procedures to complete tasks of varying scope, sequence, and complexity within the agreed timeframe. Identify and solve moderately routine problems. Complete assignments with moderate supervision using established procedures, referring deviations from standard procedures to the supervisor. Ensure work is reviewed for accuracy, quality, and adherence to standards. Prepare and operate various components, materials, equipment, and machines in your assigned area, ensuring adequate inventory of parts and materials before starting a production run. Adhere strictly to all plant safety and current Good Manufacturing Practices (cGMP) regulations. Perform in-process quality inspections, and seek to implement process and safety improvements. Sterile Preparation Operators are responsible for sterile processing of stoppers, building components and sterilizing items to be utilized in the APA (Aseptic Processing North & South facilities). 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: Staging/ racking glass and FD trays Gathering supplies from staging and sanitizing them through graded spaces Loading & unloading stoppers into processors and initiating sterilization cycles Loading and unloading autoclaves, ovens and airlocks Assist with equipment FIT and equipment troubleshooting activities. Ensuring adequate inventory of parts and materials prior to initiating a production run Utilizing computer skills to interact with multiple operating systems such as SCADA, PCS, EMS and SAP 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 aseptic certification to work within graded spaces Completing and maintaining all required training on time Other duties as assigned by the supervisor

Requirements

• High School Diploma or GED with 2+ years of relevant experience
• Strong analytical and problem-solving skills
• Excellent problem-solving and decision-making skills
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Detail-oriented with strong organizational skills
• Knowledge of unit and DP EHS procedures & policies
• Understand/trains colleagues on EHS requirements (LOTO, Confined Space Entry, Safe Work Permit)
• Supports unit safety self-inspections (helps addressing deficiencies)
• Implements safety improvements (i.e. Good Saves, manages EHS WOs)
• Works with unit safety team and/or Unit Leadership addressing safety issues (providing tools/handling work orders)
• Job Safety Assessment (Training / In-Progress)
• Meets daily GMP requirements
• Minimal errors (document entries or human performance deviations)
• Understands and follows DP & Site SOPs
• Demonstrates good GMP practice (i.e. aseptic behavior, documentation, etc.)
• Incident Reporting
• Trains colleague in alarm response & incident report (M1 form)
• Achieves and maintains QTS Access (Training)
• Understands QTS
• Participates in incident investigations and / or corrective action implementation
• Lifting/lowering up to 55 pounds and repetitive or extended sitting, standing, walking, repetitive motion and flexibility
• 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
• Permanent work authorization in the United States.

Nice To Haves

• Previous experience in cGMPs (current Good Manufacturing Practices) environment
• Proficiency in using manufacturing software and tools
• Ability to adapt to changing priorities and work in a fast-paced environment
• Demonstrated leadership skills and ability to mentor team members
• Familiarity and basic understanding of common AI tools and a curiosity for learning how they can be used to enhance productivity
• Yellow belt (in-training)

Responsibilities

• Take responsibility for individual contributions to achieve team deliverables, working effectively as a team member and coordinating with others.
• Manage personal time and professional development, being accountable for results.
• Follow standard procedures to complete tasks of varying scope, sequence, and complexity within the agreed timeframe.
• Identify and solve moderately routine problems.
• Complete assignments with moderate supervision using established procedures, referring deviations from standard procedures to the supervisor.
• Ensure work is reviewed for accuracy, quality, and adherence to standards.
• Prepare and operate various components, materials, equipment, and machines in your assigned area, ensuring adequate inventory of parts and materials before starting a production run.
• Adhere strictly to all plant safety and current Good Manufacturing Practices (cGMP) regulations.
• Perform in-process quality inspections, and seek to implement process and safety improvements.
• Manage tray inventory
• Staging and racking glass
• Gathering supplies from staging and transferring items into higher classified spaces
• Checking in stopper orders
• Coordinating efforts to ensure all items needed to be washed in tray washer are completed shiftly
• Weekly cleaning and maintenance of the tray washer every shift
• Manage washroom A operations
• Initiate and review stopper processors, ovens, autoclave cycles
• Airlock control ingoing and outgoing
• Tray Washer unloads, parts inspections and stacking of items on pallets
• Metromatic ampoule washing process
• VHP loading, initiation and review of sterilization cycles
• Manage to-go buckets and salvage bucket inventory
• Staging orders for next shift
• Unloading stoppers, autoclaves, ovens, and airlocks
• Daily Misc. Inventory checks
• Answer EMS Alarms
• Notify Lead when leaving the APA and carrying a radio
• Required to be available to support APA until 10 minutes prior to the end of shift
• Tray counts, cans, and defect buckets will be written on the bord one hour before shift change
• Support as needed in APA
• Assist with glass, dye testing or where directed by leads/designee
• 48 hours built with back-ups ahead of filling
• Maintain misc inventory for the APA sheet
• Participate in Green or Black belt project.
• Exhibits leader behaviors: 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

Benefits

• 401(k) plan with Pfizer Matching Contributions
• Additional Pfizer Retirement Savings Contribution
• Paid vacation
• Holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits to include medical, prescription drug, dental and vision coverage.
• Eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company’s policies.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED