Vaccine Formulation Tech 1 (12-hour dayshift)
Pfizer Inc.
Kalamazoo, MI
Job posting number: #7135299 (Ref:pf-4878977)
Posted: March 21, 2023
Application Deadline: Open Until Filled
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
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.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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.