Formulation Operator 1st Shift Weekends

Simtra BioPharma Solutions (Simtra) is a worldclass 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 prefilled syringes liquid/lyophilized vials diluents for reconstitution powderfilled 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 lifechanging 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 daytoday work knowing the impact we make taking on challenges big and small to improve patient health.

This role:

The Formulation Operator (Operator III) position will work in and maintain a Grade C/D environment. They will perform routine cleaning and sanitization to help ensure readiness and current Good Manufacturing Practices (cGMP) compliance within the classified and nonclassified work areas. Activities include cGMP compliant gowning conformance to Good Documentation Practices (GDP) standards weighing materials formulation of product and conducting inprocess testing and filtration. The Formulation Operator may be required to crosstrain as a support Operator for additional areas. This position reports to a Manufacturing Supervisor.

The responsibilities:

• Understand and follow current Good Manufacturing Practices (cGMP).
• Perform routine cleanup and sanitizations as assigned by area supervision to maintain cGMP compliance within the Grade C/D 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 segregation readiness and to prevent any contamination or rejection of batches.
• Compare Lot numbers to ensure correct material is being used for the specified batch
• Complete calculations to determine the amount of material to add based on final weight and sometimes potency
• Retrieve and test inprocess samples
• Use scales and balances to weigh and add wide range of raw material
• Clean and sample equipment
• Assist in the training and development of other team members
• Required to maintain attendance in accordance with the Bloomington Attendance Policy
• Scheduled weekend overtime will be

Shift Hours: Saturday/Sunday 7:00am5:30 pm plus 2 weekdays (either Mon/Tues orThurs/Fri 7:00am 3:30pm)

The work environment:

Classified pharmaceutical environment wearing required gowning. Must be able to work safely with materials to produce pharmaceutical products including chemicals compounds glassware and sanitization solutions. Must be able to occasionally 133 of the time) work in a confined/clustered work space.

Shift Hours: Saturday/Sunday 3:00pm 1:30am plus 2 weekdays (either Mon/Tues or Thurs/Fri 3:00pm 11:30pm)

Desirable 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 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 jobspecific 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 133
  • Sitting climbing stairs and ladders balancing kneeling operating controls
• Frequent 3466
  • Standing walking reaching forward and overhead stooping crouching
  • Pushing and pulling up to 110 lbs
  • Lifting and carrying up to 70 lbs
• Constant 67100
  • Object handling fingering fine hand coordination simple hand grasping firm hand grasping
• Final candidates for Formulation Operator will be required to pass a post offer/preemployment job placement examination which will test the physical capabilities to perform the essential functions of the job.

Additional requirements:

• Education and experience High School diploma or GED 6 months of previous Pharmaceutical or Manufacturing experience preferred.
• Language skills must be able to understand speak read and write English in order to comply with necessary SOP jobspecific training materials GMPs and other manuals.

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 LongTerm 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.

Know Your Rights: Workplace Discrimination is Illegal U.S. Equal Employment Opportunity Commission

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