Simtra US LLC
Manufacturing Group Lead- Capping (2nd Shift)
Simtra US LLC, Bloomington, Indiana, United States, 47401
Overview
Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines, which are all directly injected into patients worldwide. There is a strong emphasis on quality and continuous improvement at Simtra. We uphold the highest quality and regulatory standards. While our primary focus is cGMP manufacturing, we offer support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide. This role
The Capping Group Leader 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 Capping Operators who perform in the manufacturing areas. The Capping Group Leader provides decision-making and oversight to ensure compliance with regulatory agency regulations and guidelines and to 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 Capping Group Leader creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product. 2nd shift Hours: Monday-Friday 3:00pm - 11:30pm. The responsibilities
Delegate, coordinate, and schedule activities of assigned team members. Train and mentor other team members. Troubleshoot process problems and respond to process alarms. Participate on Continuous Improvement teams. Assist in developing/reviewing batch records of new and existing projects. Assist in establishing and orienting new projects for production. Review project plans and batch records prior to operations. Monitor assigned team's documentation in logbooks and batch records. Initiate exception reports as required. Organize and coordinate general cleaning and sanitizations throughout all capping suites. Identify potential causes and verify/eliminate to determine true root causes. Examine documents/processes (SOPs, equipment, methods, etc.) to prevent errors and/or recognize unexpected results. Maintain attendance in accordance with the Bloomington Attendance Policy. Scheduled weekend overtime will be required. The work environment
Classification: pharmaceutical environment with required gowning. Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions. Desirable qualifications
Ability to work independently Good communication skills Good documentation skills, including legible handwriting Good interpersonal skills Basic computer skills Basic math skills Knowledge of aseptic manufacturing practices Knowledge of standard operating procedures, specifications, and job-specific training materials Experience operating multiple types of equipment related to manufacturing operations as well as hand-operated equipment such as calipers, scales, gauges, and other measuring devices Physical / safety requirements
Occasional (0-33%): Sitting, climbing stairs and ladders, balancing, stooping, kneeling, crouching, operating controls Lifting and carrying up to 52 lbs Pushing and pulling up to 22 lbs Frequent (34-66%): Standing, walking, reaching forward and overhead Lifting and carrying up to 35 lbs Pushing and pulling up to 24 lbs Constant (67-100%): Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping Additional requirements
High school diploma or GED required 6 months of previous pharmaceutical or manufacturing experience preferred Final candidates for Capping Group Leader will 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 Benefits
In return, you’ll be eligible for Day One Benefits, including medical & dental coverage, flexible spending accounts, life and AD&D insurance, supplemental life insurance, short and long-term disability, 401(k) with company match, and time off programs. Additional benefits include adoption reimbursement, education assistance, employee assistance, community and volunteer programs, employee ownership plan, voluntary insurance benefits, onsite campus amenities, and more. 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. Equal Employment Opportunity
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. Data Privacy
To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Privacy Policy: Privacy Policy - Simtra BioPharma Solution
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Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines, which are all directly injected into patients worldwide. There is a strong emphasis on quality and continuous improvement at Simtra. We uphold the highest quality and regulatory standards. While our primary focus is cGMP manufacturing, we offer support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide. This role
The Capping Group Leader 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 Capping Operators who perform in the manufacturing areas. The Capping Group Leader provides decision-making and oversight to ensure compliance with regulatory agency regulations and guidelines and to 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 Capping Group Leader creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product. 2nd shift Hours: Monday-Friday 3:00pm - 11:30pm. The responsibilities
Delegate, coordinate, and schedule activities of assigned team members. Train and mentor other team members. Troubleshoot process problems and respond to process alarms. Participate on Continuous Improvement teams. Assist in developing/reviewing batch records of new and existing projects. Assist in establishing and orienting new projects for production. Review project plans and batch records prior to operations. Monitor assigned team's documentation in logbooks and batch records. Initiate exception reports as required. Organize and coordinate general cleaning and sanitizations throughout all capping suites. Identify potential causes and verify/eliminate to determine true root causes. Examine documents/processes (SOPs, equipment, methods, etc.) to prevent errors and/or recognize unexpected results. Maintain attendance in accordance with the Bloomington Attendance Policy. Scheduled weekend overtime will be required. The work environment
Classification: pharmaceutical environment with required gowning. Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions. Desirable qualifications
Ability to work independently Good communication skills Good documentation skills, including legible handwriting Good interpersonal skills Basic computer skills Basic math skills Knowledge of aseptic manufacturing practices Knowledge of standard operating procedures, specifications, and job-specific training materials Experience operating multiple types of equipment related to manufacturing operations as well as hand-operated equipment such as calipers, scales, gauges, and other measuring devices Physical / safety requirements
Occasional (0-33%): Sitting, climbing stairs and ladders, balancing, stooping, kneeling, crouching, operating controls Lifting and carrying up to 52 lbs Pushing and pulling up to 22 lbs Frequent (34-66%): Standing, walking, reaching forward and overhead Lifting and carrying up to 35 lbs Pushing and pulling up to 24 lbs Constant (67-100%): Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping Additional requirements
High school diploma or GED required 6 months of previous pharmaceutical or manufacturing experience preferred Final candidates for Capping Group Leader will 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 Benefits
In return, you’ll be eligible for Day One Benefits, including medical & dental coverage, flexible spending accounts, life and AD&D insurance, supplemental life insurance, short and long-term disability, 401(k) with company match, and time off programs. Additional benefits include adoption reimbursement, education assistance, employee assistance, community and volunteer programs, employee ownership plan, voluntary insurance benefits, onsite campus amenities, and more. 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. Equal Employment Opportunity
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. Data Privacy
To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Privacy Policy: Privacy Policy - Simtra BioPharma Solution
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