Filling Group Leader (3rd Shift)

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical company is seeking a Filling Group Leader to oversee and support manufacturing operations. The role requires coordination of team activities, adherence to regulatory standards, and fostering a culture of quality and compliance. Ideal candidates should possess a high school diploma and prior experience in a related field.

Benefits

Medical & Dental Coverage

401(k) Retirement Savings Plan with Company Match

Flexible Spending Accounts

Short and Long-Term Disability Insurance

Education Assistance Program

Qualifications

• Ability to work independently and with a team.
• Previous Pharmaceutical or Manufacturing experience preferred.
• Knowledge of standard operating procedures.

Responsibilities

• Delegate and coordinate activities of team members.
• Train and mentor team members.
• Ensure compliance with regulatory standards.

Skills

Interpersonal skills

Basic computer skills

Basic math skills

Independent working

Knowledge of aseptic manufacturing practices

Education

High school diploma or GED

Tools

Calipers

Scales

Gauges

Job description

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/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
• 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. 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 work space.

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
  • 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 ( 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 requirement(s):

• 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 which will test the physical capabilities to perform the essential functions of the job.

In return, you’ll be eligible for[1]:

• 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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