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

The Vaccine Formulation Tech role is responsible for processing and formulating the COVID19 vaccine in the new Vaccine Formulation Facility (VFF).  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 formulation area with a variety of different equipment types (tanks, pumps, centrifuges, scales, filters, and other vaccine formulation equipment) 

• 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  

• Other duties as assigned by the supervisor.

How You Will Achieve It

• Manage own time, professional development and be accountable for own results.

• Perform documentation review of production batch records within defined timelines.

• Provide feedback to leadership regarding issues and errors with Good Manufacturing Practices {also cGMP} documentation.

• Perform a variety of miscellaneous tasks in support of other production units.

• Managing purchases for the unit, handle controlled substances and other materials or chemicals.

• Perform all tasks in strict compliance with operating procedures, best practices and regulatory requirements.

• Coordinate departmental projects and activities, and learn activities and tasks associated with own role.

• Contribute to creative conversation {e.g., brainstorming and innovation) and help to clarify comments of others.

• Contribute when team is in feedback mode and demonstrate ability to work closely with others.

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   

• All vaccine formulation 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  

• Can perform disposals 

• 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.   

Qualifications

Must-Have

• High School Diploma or GED

• Basic company/industry knowledge

• Math and reading skills required for Standard Operating Procedure, Good Manufacturing Practices {also cGMP} and Batch Record comprehension

• Ability to facilitate trust and understanding

• Demonstrated interpersonal leadership and accountability in day-to-day interactions with an operational focus on customer needs and process requirements

• Experience with computer applications, such as MS Word, Excel and Outlook

Nice-to-Have

• Pharmaceutical or manufacturing experience is preferred with an understanding of cGMPs and Good Documentation Practices

• Mechanical experience/aptitude 

• Experience handling biologic substances, APIs, or drug products 

PHYSICAL/MENTAL REQUIREMENTS

• 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

This position supports a 24x7x365 operation.    

Day Shift: This position will align work schedule to support a 6am to 6pm team with a rotating 2-2-3 schedule. This schedule provides every other weekend off. Holiday and overtime may be required to meet business needs.  

Work Location Assignment: On Premise

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