Formulation & Preparation Operator

Summary :

The F ormulation Preparation Operator (Operator II III ) position supports aseptic filling operations by staging and delivering components, conducting in-process testing , weighing materials, formulation of product, and conducting in-process testing , filtration , cleaning and sanitization , sterilization of equipment, batch reconciliation, compliant gowning, setup and operation of parts washer, autoclaves, and tank cleaning in conformance with current Good Manufacturing Practices and Good Documentation Practices (cGMP/GDP) standards. The Operator will also initiate minor revisions to existing documents and troubleshoot simple processes / equipment failures. The Operator may be required to cross-train as a support Operator for additional areas. This position reports to the Manufacturing Supervisor.

Shift structures:

1: M-Th 7:00 – 16:00

2: M-Th 15:00 – 00:00

3: M-Th 23:00 - 8:00

4: Fr-Su 7:00 – 19:30

5: Fr-Su 19:00 – 7:30

Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned) :

Understand and follow current Good Manufacturing Practices (GMP)

Understand and follow current Good Documentation Practices (GDP)

Perform routine cleanup, line clearances, and sanitizations as assigned by area supervision to maintain cGMP compliance within the Cleanroom work areas. Perform sanitizations in a timely and effective manner in accordance with cGMPs and Simtra procedures, maintaining production schedule.

May be required to cross train as a support operator to assist additional manufacturing areas.

Maintain organization at all times within the classified areas to ensure equipment segregation, readiness and to prevent any contamination or rejection of batches.

Perform routine verification of equipment and instruments.

Compare Lot numbers to ensure correct components are being used for the specified batch

Complete calculations to support preparation and formulation activities

Retrieve and test in-process samples

Clean, Sterilize, and sample equipment

Setup and operate autocalves, parts washers, tank cleaning, and formulation stations in Cleanroom areas.

Assist in the training and development of other team members

Required to maintain attendance in accordance with the Bloomington Attendance Policy

Scheduled weekend overtime may be required

Job Requirements (Education, Experience and Qualifications ):

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 SOP’s, job-specific training materials, GMP’s, and other manuals.

Basic Computer skills in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: Veeva, D365, Blue Mountain, etc.)

Must have the ability to work effectively in a ”hands on environment” capable of troubleshooting complex equipment and systems

Competency in operation 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. Ability to demonstrate proficiency in reading equipment drawings. Ability to work safely with equipment under pressure.

Physical / Safety Requirements

Must be able to lift and carry up to 70 lbs, and push and pull up to 150 lbs.

Extended periods of standing and/or walking

Extended periods in Grade A, B, C, D production environments

Use of hands and fingers to manipulate equipment is required

In return, you’ll be eligible for [1] :

Day One Benefits

Medical Dental Coverage

Flexible Spending Accounts

Life and AD D Insurance

Supplemental Life Insurance

Spouse Life Insurance

Child Life 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

Short and Long-Term Disability Insurance

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 12/31/26

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. Employees must be in their current position for a minimum of twelve (12) months and be in good standing before applying for other internal opportunities.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtr…