U-05 Sterile Product Specialist B - 2nd Shift (3:00pm-11:30pm) - Pfizer
Rochester, MI
About the Job
Why Patients Need You
Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what's possible and taking action.
What You Will Achieve
The Sterile Process Specialist (SPS) is responsible for the manufacturing (micronizing, formulation and filling) of aseptic products. In addition, the selected candidates will be responsible for cleaning, preparing and sterilizing equipment and components needed in the manufacturing of aseptic products.
Strictly following procedures, guidelines and site policies is a requirement of the position.
How You Will Achieve It
The essential duties for this position include but are not limited to:
+ Performs all tasks as outlined in batch records, procedures, and job aids.
+ Legibly records data in batch records, logs and other GMP documentation.
+ Verifies materials and equipment against the batch record and assures materials are correct and approved.
+ Supplies components, equipment and miscellaneous items to the manufacturing area as needed to maintain the production schedule.
+ Performs checks, calculations and completes documentation as required to comply with procedures.
+ Operates, cleans, lubricates, services, and makes minor repairs/adjustments to production equipment.
+ Labels, dispenses and samples materials.
+ Performs calibration verifications on production equipment.
+ Accurately weighs, measures, mills and dispenses ingredients in accordance with batch records and procedures.
+ Cleans and sterilizes process equipment using clean-in-place (CIP) and steam-in-place (SIP) systems.
+ Assembles, operates, cleans and troubleshoots micronizing, formulation and aseptic filling equipment.
+ Cleans, assembles, prepares and sterilizes equipment.
+ Maintains a high level of cleanliness and housekeeping of all manufacturing areas.
+ Performs other duties as assigned by supervision.
General Expectations
+ Work in a safe manner and report all potential safety issues to leadership in a timely manner.
+ Perform all tasks in strict compliance with operating procedures, best practices and regulatory requirements.
+ Dependable - Follows unit / area / plant requirements and guidelines.
+ Willing to assist other production units in order to meet unit / site goals.
+ Maintain Pfizer Learning System (PLS) training at or above 98%.
+ Perform a variety of miscellaneous tasks in support of the Rochester Site objectives.
Communication and Leadership Expectations
+ Consistently displays behaviors in accordance with Pfizer Core Competencies: Seizes accountability; grows self; change agile; self-awareness; commits to one Pfizer; peer relationships.
+ Train and mentor new colleagues and contracted resources.
+ Provide feedback to leadership regarding issues and errors with GMP documentation.
+ Understands basic problem-solving methods (Method 1 training).
+ Coordinates with maintenance to complete repairs and develop solutions to equipment issues.
Training Step Progression Requirements:
Position
+ Sterile Process Specialist (SPS) 1- Prep Area.
+ Sterile Process Specialist (SPS) 2 - Bulk Formulation.
+ Sterile Process Specialist (SPS) 3 - Micronize API.
+ Sterile Process Specialist (SPS) 4 - Filling.
Starting wage classification
+ = Sterile Machine Operator (SMO) (< Aseptic Service Technician (AST)).
+ = Aseptic Service Technician (AST) (>Sterile Machine Operator (SMO)).
+ > Aseptic Service Technician (AST) & < Packaging Machine Operator (PMO).
+ = Packaging Machine Operator (PMO).
Training activities on this level
Activities performed in Grade D & Grade C rooms, such as but not limited to:
+ Clean parts, wrap parts, materials transfer, run sterilizer / UV, restock materials, test filters/suits/gloves, tub feeder etc.
+ All of SPS 1 PLUS: Clean-in-place (CIP) and steam-in-place (SIP), gel, formulate, unload sterilizer, etc.
+ All SPS 2 PLUS: Install suits, set up micronizer, Micronize, dispense API, TD/CU micronizer etc.
+ All SPS3 PLUS: Set up filler, run filler, TD/CU filler, fill check.
Driver for qualification (signed off) on this level
+ Qualified in all Sterile Process Specialist (SPS) 1 activities.
+ Aseptic gown qualified/Qualified in all Sterile Process Specialist (SPS) 2 activities.
+ Qualified in all Sterile Process Specialist (SPS) 3 activities.
+ Media Fill qualified/Qualified in all Sterile Process Specialist (SPS) 4 activities.
Estimated training period
+ 6-12 months.
Wage classification once fully qualified
+ = Aseptic Service Technician (AST) (> Sterile Machine Operator (SMO)).
+ >Aseptic Service Technician (AST) & < Packaging Machine Operator (PMO).
+ = Packaging Machine Operator (PMO).
+ = Sterile Process Specialist (SPS) (>Packaging Machine Operator (PMO)).
Qualifications
Must-Have
+ High school diploma / general education degree (GED) plus either an associate's degree or six months of work experience (e.g. current or previous Pfizer colleague; Mfg., Pkg. or Veterans/Military relevant experience).
+ Math and reading skills required for SOP, GMP and Batch Record comprehension.
+ Ability to contribute to department success in a team environment and perform tasks at a productive level under demanding conditions is mandatory.
+ Must be self-motivated and willing to learn new and changing responsibilities.
+ Demonstrated ability to direct daily activities to meet production schedule.
Physical/Mental Requirements
+ This position is located in a penicillin facility. The candidates must not be allergic to penicillin.
+ Must be able to fully gown in aseptic garb for extended periods of time.
+ Considerable standing, walking, bending, reaching and lifting up to 50 pounds.
+ Must be available to work extended hours and weekends if required to meet production goals.
Non-Standard Work Schedule, Travel, or Environment Requirements
+ This is a 2nd shift position with core hours from 3:00 pm to 11:30 pm (Monday through Friday) with overtime required as needed.
+ Work Location Assignment: On Premise.
Other job details
+ Eligible for employee referral bonus: Yes.
Work Location Assignment: On Premise
The salary for this position ranges from $0,00 to $0,00 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 - Rochester 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.
Engineering
#LI-PFE
Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what's possible and taking action.
What You Will Achieve
The Sterile Process Specialist (SPS) is responsible for the manufacturing (micronizing, formulation and filling) of aseptic products. In addition, the selected candidates will be responsible for cleaning, preparing and sterilizing equipment and components needed in the manufacturing of aseptic products.
Strictly following procedures, guidelines and site policies is a requirement of the position.
How You Will Achieve It
The essential duties for this position include but are not limited to:
+ Performs all tasks as outlined in batch records, procedures, and job aids.
+ Legibly records data in batch records, logs and other GMP documentation.
+ Verifies materials and equipment against the batch record and assures materials are correct and approved.
+ Supplies components, equipment and miscellaneous items to the manufacturing area as needed to maintain the production schedule.
+ Performs checks, calculations and completes documentation as required to comply with procedures.
+ Operates, cleans, lubricates, services, and makes minor repairs/adjustments to production equipment.
+ Labels, dispenses and samples materials.
+ Performs calibration verifications on production equipment.
+ Accurately weighs, measures, mills and dispenses ingredients in accordance with batch records and procedures.
+ Cleans and sterilizes process equipment using clean-in-place (CIP) and steam-in-place (SIP) systems.
+ Assembles, operates, cleans and troubleshoots micronizing, formulation and aseptic filling equipment.
+ Cleans, assembles, prepares and sterilizes equipment.
+ Maintains a high level of cleanliness and housekeeping of all manufacturing areas.
+ Performs other duties as assigned by supervision.
General Expectations
+ Work in a safe manner and report all potential safety issues to leadership in a timely manner.
+ Perform all tasks in strict compliance with operating procedures, best practices and regulatory requirements.
+ Dependable - Follows unit / area / plant requirements and guidelines.
+ Willing to assist other production units in order to meet unit / site goals.
+ Maintain Pfizer Learning System (PLS) training at or above 98%.
+ Perform a variety of miscellaneous tasks in support of the Rochester Site objectives.
Communication and Leadership Expectations
+ Consistently displays behaviors in accordance with Pfizer Core Competencies: Seizes accountability; grows self; change agile; self-awareness; commits to one Pfizer; peer relationships.
+ Train and mentor new colleagues and contracted resources.
+ Provide feedback to leadership regarding issues and errors with GMP documentation.
+ Understands basic problem-solving methods (Method 1 training).
+ Coordinates with maintenance to complete repairs and develop solutions to equipment issues.
Training Step Progression Requirements:
Position
+ Sterile Process Specialist (SPS) 1- Prep Area.
+ Sterile Process Specialist (SPS) 2 - Bulk Formulation.
+ Sterile Process Specialist (SPS) 3 - Micronize API.
+ Sterile Process Specialist (SPS) 4 - Filling.
Starting wage classification
+ = Sterile Machine Operator (SMO) (< Aseptic Service Technician (AST)).
+ = Aseptic Service Technician (AST) (>Sterile Machine Operator (SMO)).
+ > Aseptic Service Technician (AST) & < Packaging Machine Operator (PMO).
+ = Packaging Machine Operator (PMO).
Training activities on this level
Activities performed in Grade D & Grade C rooms, such as but not limited to:
+ Clean parts, wrap parts, materials transfer, run sterilizer / UV, restock materials, test filters/suits/gloves, tub feeder etc.
+ All of SPS 1 PLUS: Clean-in-place (CIP) and steam-in-place (SIP), gel, formulate, unload sterilizer, etc.
+ All SPS 2 PLUS: Install suits, set up micronizer, Micronize, dispense API, TD/CU micronizer etc.
+ All SPS3 PLUS: Set up filler, run filler, TD/CU filler, fill check.
Driver for qualification (signed off) on this level
+ Qualified in all Sterile Process Specialist (SPS) 1 activities.
+ Aseptic gown qualified/Qualified in all Sterile Process Specialist (SPS) 2 activities.
+ Qualified in all Sterile Process Specialist (SPS) 3 activities.
+ Media Fill qualified/Qualified in all Sterile Process Specialist (SPS) 4 activities.
Estimated training period
+ 6-12 months.
Wage classification once fully qualified
+ = Aseptic Service Technician (AST) (> Sterile Machine Operator (SMO)).
+ >Aseptic Service Technician (AST) & < Packaging Machine Operator (PMO).
+ = Packaging Machine Operator (PMO).
+ = Sterile Process Specialist (SPS) (>Packaging Machine Operator (PMO)).
Qualifications
Must-Have
+ High school diploma / general education degree (GED) plus either an associate's degree or six months of work experience (e.g. current or previous Pfizer colleague; Mfg., Pkg. or Veterans/Military relevant experience).
+ Math and reading skills required for SOP, GMP and Batch Record comprehension.
+ Ability to contribute to department success in a team environment and perform tasks at a productive level under demanding conditions is mandatory.
+ Must be self-motivated and willing to learn new and changing responsibilities.
+ Demonstrated ability to direct daily activities to meet production schedule.
Physical/Mental Requirements
+ This position is located in a penicillin facility. The candidates must not be allergic to penicillin.
+ Must be able to fully gown in aseptic garb for extended periods of time.
+ Considerable standing, walking, bending, reaching and lifting up to 50 pounds.
+ Must be available to work extended hours and weekends if required to meet production goals.
Non-Standard Work Schedule, Travel, or Environment Requirements
+ This is a 2nd shift position with core hours from 3:00 pm to 11:30 pm (Monday through Friday) with overtime required as needed.
+ Work Location Assignment: On Premise.
Other job details
+ Eligible for employee referral bonus: Yes.
Work Location Assignment: On Premise
The salary for this position ranges from $0,00 to $0,00 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 - Rochester 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.
Engineering
#LI-PFE
Source : Pfizer