Manufacturing Group Lead- Capping (Weekend AM)

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. As such there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing we offer many 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.

Why join Team Simtra Because we:

Make it HAPPEN We bring a growth mindset to every opportunity developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER We work as one respecting each voice and tapping into our unique strengths across teamsso we can solve problems in new ways.

Make it RIGHT We hold ourselves to a high standard of excellencefulfilling our commitments to the customer their patients and our team members.

Make it COUNT We take pride in our day-to-day work knowing the impact we make taking on challenges big and small to improve patient health.

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 to all 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.

Weekend PM 7am-7:30pm (Friday - Monday)

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 teams documentation in logbooks and batch records.
• Initiate exception reports as required.
• Organize and coordinate general cleaning and sanitizations throughout all capping suites. Efficiently identify potential causes and verify/eliminate each one to determine the true root cause behaviors
• Examine documents/processes (SOPs equipment methods etc.) to prevent errors and/or recognize unexpected results.
• Required to maintain attendance in accordance with the Bloomington Attendance Policy
• Scheduled weekend overtime will be required

The work environment:

Classified pharmaceutical environment wearing required gowning as shown in attached document. 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
• 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 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 requirement(s):

• • 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.

In return youll be eligible for1:

• Day One Benefits
  • 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.

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 Simtras approach to data privacy please review the Simtra Recruitment Platform Privacy Policy:
Privacy Policy Simtra BioPharma Solution