Operations Technician (2nd Shift APS Filling)
Pfizer Inc.
Kalamazoo, MI
Job posting number: #7136073 (Ref:pf-4880734)
Posted: March 24, 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
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.
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:
GMP
Performs basic daily & non-daily Filling processes without assistance
Performs advanced Filling processes with minimal assistance
GMP record entries (complete with minimal errors)
Exhibits good aseptic behavior (Certifications maintained)
Meets daily GMP requirements - minimal human errors (Ongoing)
Maintains training requirements (up to date per unit goals)
Maintains Working Areas Audit Ready (GMP/5S)
Filling Operations
Appropriately display ability to troubleshoot and adjust line equipment
Understanding of advanced Filling 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
Assist with investigations and document updates
Provide SME guidance when needed
Other:
Identifies unit improvements (i.e. safety, process, cost, efficiency, etc.)
Participates site programs (i.e. Safety, Zero Defects, etc.)
Trains others when requested
Qualifications
Must-Have
High School Diploma or GED
4+ years of experience
24 months as an Assistant Operations Technician, OR
48+ months of relevant GMP experience in an aseptic environment (e.g. freeze dry, manufacturing, prep, or similar)
PHYSICAL/MENTAL REQUIREMENTS
The position involves extensive lifting, sitting, standing, walking, repetitive motion, flexibility, aseptic gowning, and routine weekend work.
Able to work under full clean room (GRADE A/B/C/D) environments with appropriate gowning
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Must be able to work overtime, weekends, and holidays as necessary.
8 hour shifts M - F and 1 12 hour shift every other weekend
Other Job Details
Last Date to Apply for Job: March 29 st 2023
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.