Preparation Group Leader (3rd Shift)

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 40,000 - 70,000; Full time

Job summary

An established industry player is seeking a Prep Group Lead to join their Manufacturing Leadership Team. This role is pivotal in ensuring that all products meet required specifications through effective coordination of manufacturing activities. The ideal candidate will lead a team, ensure compliance with Good Manufacturing Practices, and engage in continuous improvement initiatives. You will work in a classified pharmaceutical environment, requiring adherence to safety protocols and effective communication with various stakeholders. This position offers a unique opportunity to contribute to quality operations and drive excellence in production processes.

Benefits

Medical & Dental Coverage

Flexible Spending Accounts

401(k) Retirement Savings Plan with Company Match

Paid Time Off

Education Assistance Program

Employee Assistance Program

Community and Volunteer Service Program

Onsite Workout Facility

Onsite Cafeteria

Onsite Credit Union

Qualifications

• High school diploma or GED required with 6 months of relevant experience preferred.
• Ability to understand and follow SOPs and GMPs in English.

Responsibilities

• Coordinate activities of Preparation Operators to ensure compliance with regulations.
• Monitor and record critical process parameters and maintain production equipment.

Skills

Good Manufacturing Practices

Communication Skills

Interpersonal Skills

Basic Math Skills

Aseptic Manufacturing Practices

Education

High School Diploma or GED

Tools

Filtration Systems

Production Equipment (autoclaves, vial washers)

Measuring Devices (calipers, scales)

Job description

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 communication skills
• Good interpersonal 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
• Must be able to understand, speak, read and write English in order to comply with necessary SOPs, job-specific training materials, GMPs, and other manuals.
• Final candidates for Preparation 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:

• 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

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.