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Manufacturing Group Lead- Aseptic Filling; Weekend PM

Job in Bloomington, Monroe County, Indiana, 47401, USA
Listing for: Simtra BioPharma Solutions
Full Time position
Listed on 2026-01-02
Job specializations:
  • Manufacturing / Production
    Manufacturing Engineer, Manufacturing Production
Job Description & How to Apply Below
Position: Manufacturing Group Lead- Aseptic Filling (Weekend PM)

Manufacturing Group Lead
- Aseptic Filling (Weekend PM)

The Filling 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 Filling Operators who perform in the manufacturing areas. The Filling Group Leader 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 Filling Group Leader creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product.

The responsibilities
  • Delegate, coordinate, and schedule activities of assigned team members.
  • Recommend measures to improve performance and increase efficiency.
  • Train and mentor other team members.
  • Troubleshoot process problems and respond to process alarms.
  • Participate on Continuous Improvement teams.
  • Assist in developing and 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.
  • Organize and coordinate general cleaning and sanitizations throughout all filling suites.
  • Identify potential causes and verify/eliminate each one to determine the true root cause behavior.
  • Maintain attendance in accordance with the Bloomington Attendance Policy.
  • Schedule weekend overtime as required.
The work environment

Classified pharmaceutical environment wearing required gowning. Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware, and sanitization solutions. Must be able to occasionally (1‑33% of the time) work in a confined/clustered workspace.

Requirements / Qualifications

To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals to perform the essential functions.

  • Ability to work independently.
  • 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/Subject Matter Expert.
  • Experience operating multiple types of equipment related to manufacturing operations as well as hand‑operated equipment, including calipers, scales, gauges, and other measuring devices.
Physical / safety requirements
  • Occasional (1‑33%):
    Sitting, climbing stairs and ladders, balancing, kneeling, operating controls.
  • Lifting and carrying up to 70 lbs;
    Pushing and pulling up to 35 lbs.
  • Frequent (34‑66%):
    Standing, walking, reaching forward and overhead, stooping, crouching.
  • Lifting and carrying up to 37 lbs;
    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 Filling Group Leader will be required to pass a post‑offer/pre‑employment job placement examination that tests the physical capabilities to perform the essential functions of the job.
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…
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