Process Technician 1 (2nd Shift)
- Employer
- Pfizer
- Location
- Kalamazoo, Michigan
- Start date
- Sep 26, 2022
View more
- Discipline
- Engineering, Manufacturing & Production, Process
- Required Education
- High School or equivalent
- Position Type
- Full time
- Hotbed
- Best Places to Work
***Pfizer now offering ***** sign-on bonus for successful hire through December 31st***
Schedule Subject to Change
ROLE OVERVIEWThe Biological Operations Tech role is responsible for processing raw materials (i.e. human and equine blood and plasma) into Stroma to be used in the formulation of ATGAM Purified Drug Substance by means of a large-scale biologic separation processes (i.e. centrifugation). 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 biological processing area with a variety of different equipment types (tanks, pumps, centrifuges, scales, filters, freeze dryers, etc.)
Washing, sanitizingand cleaning facilities and equipment
Handling, Charging and packaging materials
Monitoring process parameters and batch end reportsfor quality or equipment concerns
Utilizingcomputer skills to interact with multiple complex PLC and SCADA systems
Collaboratingwith maintenance and engineers totroubleshootequipment and perform TPM tasks
Supportingdevelopment andexecution of capital projects, corrective actions, and continuous improvement ideas
Demonstratinggrowth mindset to share best practices & utilize downtime effectively
Workingsafely and compliantly following all applicable SOPs and standards including recording of GMP documentation
Completing and maintaining all required training on time
Demonstrating ownership and accountabilityof theproduction schedule and product quality
Executing in-process quality inspections
Other duties as assigned by the supervisor
Overview: As the entry levelrole in this career path, the colleague is expected to show progression towards all the items below and competency on a growing number of them as the duration in the role progresses.
EHS
Safety Orientation &Safety OJT training
LOTO / Safe work permits / Confined space Awareness
Unit safety self-inspections
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
Stroma process and Blood Room operations (with assistance)
Setting up and operating biological operations 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
Weekend Rotation (participation)
Maintain area audit readiness
Display cGMP’s at all times
Identify issues, respond, and escalate appropriately
Complete andaccuratehandoffs
Operatorcare activities
Facility cleaning for routine and special cause events
Batchrecordreview
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
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 AchieveAs part of technical operations, you will be a team member who is relied to have a good understanding of procedures, techniques, tools, materials and equipment. Your decision making will help you prioritize workflows based on the available resources. You will follow standard procedures to complete tasks, some of which may vary in scope, sequence, complexity and timing. You will contribute to the team’s success by sharing your previously acquired knowledge.
It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve ItManage own time and professional development, be accountable for own results and begin to prioritize own workflow.
Responsible for the preparation and/or operation of various components, materials, equipment, machines including, but not limited to any and/or all applicable components, materials, equipment, machines in the assigned area(s).
Complete adherence to all plant safety and (current) Good Manufacturing Practices {also cGMP} regulations to the highest.
Assist with diagnosis and troubleshooting activities and execute in-process quality inspections.
Ensure adequate inventory of parts and materials prior to initiating a production run.
Identify and seek to implement process and safety improvement and perform all tasks in a safe manner.
Participate in shift meetings, provide hand off information and communicate with other units and shifts.
Education and Experience:
High school diploma / general education degree (GED) plus
An associate degree, OR
Veteran/Military experience, OR
Six months of relevant work experience in a manufacturing or GMP facility (e.g. current or previous Pfizer colleague or contractor or similar)
In addition, the following skills are preferred:
Mechanical experience/aptitude
Experience handling biologic substances, APIs, or drug products
Work Location Assignment:On Premise
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
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTSPositions are staffed across all three shifts. Specific shift schedules may vary by specific operational area. Weekend, holiday, and overtime may be required to meet business or customer needs.
Last Date to Apply for Job: September 16th, 2022
Eligible for Relocation Package: NO
Eligible for Employee Referral Bonus: YES
#LI-PFE
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.
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