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Posted : Tuesday, April 16, 2024 07:41 PM
Why Patients Need You
The Biological Operations Tech role is responsible for blood processing activities and/or processing raw materials (i.
e.
human blood) 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: What You Will Achieve Performing unit operations in the biological processing area with a variety of different equipment types (tanks, pumps, centrifuges, scales, filters, freeze dryers, etc.
) 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 Overview: As the entry level role 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) BIOLOGICAL OPERATIONS Stroma process and/or 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 specificand 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 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 Alarm response & notification awareness QUALIFICATIONS Must- Have High school diploma / general education degree (GED) plus An associate degree, OR Veteran/Military experience, OR 6 months of relevant work experience in a manufacturing or GMP facility (e.
g.
current or previous Pfizer colleague or contractor or similar) Nice to -Have Mechanical experience/aptitude Experience handling biologic substances, APIs, or drug products 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 Positions 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.
Work Location Assignment: On Premise Last Day to Apply: March 11, 2024 The salary for this position ranges from $18.
74 to $31.
23 per hour.
In addition, this position offers eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company’s policies.
We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments.
Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage.
Learn more at Pfizer Candidate Site – U.
S.
Benefits | (uscandidates.
mypfizerbenefits.
com).
Pfizer compensation structures and benefit packages are aligned based on the location of hire.
The United States salary range provided applies only to the United States - Michigan - Kalamazoo location.
Relocation assistance may be available based on business needs and/or eligibility.
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.
This position requires permanent work authorization in the United States.
Manufacturing #LI-PFE
e.
human blood) 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: What You Will Achieve Performing unit operations in the biological processing area with a variety of different equipment types (tanks, pumps, centrifuges, scales, filters, freeze dryers, etc.
) 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 Overview: As the entry level role 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) BIOLOGICAL OPERATIONS Stroma process and/or 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 specificand 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 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 Alarm response & notification awareness QUALIFICATIONS Must- Have High school diploma / general education degree (GED) plus An associate degree, OR Veteran/Military experience, OR 6 months of relevant work experience in a manufacturing or GMP facility (e.
g.
current or previous Pfizer colleague or contractor or similar) Nice to -Have Mechanical experience/aptitude Experience handling biologic substances, APIs, or drug products 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 Positions 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.
Work Location Assignment: On Premise Last Day to Apply: March 11, 2024 The salary for this position ranges from $18.
74 to $31.
23 per hour.
In addition, this position offers eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company’s policies.
We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments.
Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage.
Learn more at Pfizer Candidate Site – U.
S.
Benefits | (uscandidates.
mypfizerbenefits.
com).
Pfizer compensation structures and benefit packages are aligned based on the location of hire.
The United States salary range provided applies only to the United States - Michigan - Kalamazoo location.
Relocation assistance may be available based on business needs and/or eligibility.
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.
This position requires permanent work authorization in the United States.
Manufacturing #LI-PFE
• Phone : NA
• Location : Kalamazoo, MI
• Post ID: 9104058792
