Simtra BioPharma Solutions
Manufacturing Group Lead- Preparation (Weekend PM),
Simtra BioPharma Solutions, Bloomington, Indiana, United States, 47401
Overview
The Prep Group Lead is a member of the Manufacturing Leadership Team reporting directly to the Manufacturing Supervisor. They provide direct support to manufacturing to ensure that finished products meet the required specifications by coordinating activities of Preparation Operators who perform in the manufacturing areas. The Prep Group Lead provides decision-making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures. This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments. The responsibilities
Understand and follow current Good Manufacturing Practices Assemble and operate filtration systems Operate general production equipment (such as autoclaves, vial washers, depyrogenation ovens, scales and balances, etc) Monitor and record critical process parameters Complete all relevant paperwork following GDP/GMP guidelines Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion Perform sampling using aseptic techniques Participate on Continuous Improvement Teams Train and mentor other team members Write, revise and review pertinent documentation as appropriate Troubleshoot process problems and respond to process alarms Assist with process/equipment validation and data analysis Work with other groups such as maintenance/metrology and calibration to ensure preventative maintenance completion. Required to maintain attendance in accordance with the Bloomington Attendance Policy Scheduled weekend overtime will be required The work environment
Classified pharmaceutical environment including wearing required gowning as shown in attached document. Occasional work with water and pharmaceutical product while wearing applicable Personal Protective Equipment. Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions. Ability to work independently Good communicationskills Good interpersonal skills Basic math skills Knowledge of aseptic manufacturing practices Knowledge of standard operating procedures, specifications, and job-specific trainingmaterials Requires the operations of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices Physical / safety requirements
Occasional(0-33%) Sitting, climbing stairs and ladders, balancing, stooping, kneeling, crouching, operatingcontrols Lifting and carryingup to52lbs Pushingand pullingup to 22lbs Frequent(34-66%) Standing, walking, reaching forward and overhead Liftingand carryingup to 35lbs Pushingand pullingup to 24lbs Constant(67-100%) Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping Additional requirement(s)
Highschool diploma or GEDrequired 6 months ofpreviousPharmaceuticalor Manufacturing experience preferred Must be able to understand, speak,readand write Englishin order tocomply withnecessary SOP’,job-specific training materials, GMP’s, and other manuals. Final candidates for Preparation Group Leaderwill be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job. In return, you’ll be eligible for
Medical & Dental Coverage Flexible Spending Accounts Life and AD&D Insurance Supplemental Life Insurance
Spouse Life Insurance Child Life Insurance
Short and Long-Term Disability Insurance 401(k) Retirement Savings Plan with Company Match Time Off Program
Paid Holidays Paid Time Off Paid Parental Leave and more
Adoption Reimbursement Program Education Assistance Program Employee Assistance Program Community and Volunteer Service Program Employee Ownership Plan Additional Benefits
Voluntary Insurance Benefits
Vision Coverage Accident Critical Illness Hospital Indemnity Insurance Identity Theft Protection Legal and more
Onsite Campus Amenities
Workout Facility Cafeteria Credit Union
[1] Current benefit offerings are in effect through 12/31/25 Disclaimer
This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements. Simtra is an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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The Prep Group Lead is a member of the Manufacturing Leadership Team reporting directly to the Manufacturing Supervisor. They provide direct support to manufacturing to ensure that finished products meet the required specifications by coordinating activities of Preparation Operators who perform in the manufacturing areas. The Prep Group Lead provides decision-making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures. This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments. The responsibilities
Understand and follow current Good Manufacturing Practices Assemble and operate filtration systems Operate general production equipment (such as autoclaves, vial washers, depyrogenation ovens, scales and balances, etc) Monitor and record critical process parameters Complete all relevant paperwork following GDP/GMP guidelines Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion Perform sampling using aseptic techniques Participate on Continuous Improvement Teams Train and mentor other team members Write, revise and review pertinent documentation as appropriate Troubleshoot process problems and respond to process alarms Assist with process/equipment validation and data analysis Work with other groups such as maintenance/metrology and calibration to ensure preventative maintenance completion. Required to maintain attendance in accordance with the Bloomington Attendance Policy Scheduled weekend overtime will be required The work environment
Classified pharmaceutical environment including wearing required gowning as shown in attached document. Occasional work with water and pharmaceutical product while wearing applicable Personal Protective Equipment. Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions. Ability to work independently Good communicationskills Good interpersonal skills Basic math skills Knowledge of aseptic manufacturing practices Knowledge of standard operating procedures, specifications, and job-specific trainingmaterials Requires the operations of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices Physical / safety requirements
Occasional(0-33%) Sitting, climbing stairs and ladders, balancing, stooping, kneeling, crouching, operatingcontrols Lifting and carryingup to52lbs Pushingand pullingup to 22lbs Frequent(34-66%) Standing, walking, reaching forward and overhead Liftingand carryingup to 35lbs Pushingand pullingup to 24lbs Constant(67-100%) Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping Additional requirement(s)
Highschool diploma or GEDrequired 6 months ofpreviousPharmaceuticalor Manufacturing experience preferred Must be able to understand, speak,readand write Englishin order tocomply withnecessary SOP’,job-specific training materials, GMP’s, and other manuals. Final candidates for Preparation Group Leaderwill be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job. In return, you’ll be eligible for
Medical & Dental Coverage Flexible Spending Accounts Life and AD&D Insurance Supplemental Life Insurance
Spouse Life Insurance Child Life Insurance
Short and Long-Term Disability Insurance 401(k) Retirement Savings Plan with Company Match Time Off Program
Paid Holidays Paid Time Off Paid Parental Leave and more
Adoption Reimbursement Program Education Assistance Program Employee Assistance Program Community and Volunteer Service Program Employee Ownership Plan Additional Benefits
Voluntary Insurance Benefits
Vision Coverage Accident Critical Illness Hospital Indemnity Insurance Identity Theft Protection Legal and more
Onsite Campus Amenities
Workout Facility Cafeteria Credit Union
[1] Current benefit offerings are in effect through 12/31/25 Disclaimer
This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements. Simtra is an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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