Preparation Operator, 3rd Shift Weekends

Simtra BioPharma Solutions (Simtra) is a world-class 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 pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled 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 life-changing 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 teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Prep Operator (Operator II) 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 non-classified work areas. Activities shall include cGMP compliant gowning, conformance to Good Documentation Practices (GDP) standards, integrity testing of filters, and cleaning, setup, and sterilization of equipment and components. Ability to operate preparation equipment such as autoclaves, sonicators, depyrogenation ovens, and vial and stopper washers. The Preparation Operator may be required to cross-train as a support Operator for additional areas. This position reports to the Manufacturing Supervisor.

This position is required to work all designated plant holidays.

3rd shift, Weekends: Saturday/Sunday 11pm – 9:30am, plus 2 weekdays (either Mon/Tues or Thurs/Fri) 11pm – 7:30am.

The responsibilities:

• Understand and follow current Good Manufacturing Practices
• 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
• 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 components are being used for the specified batch
• Complete calculations to support preparation activities
• Retrieve and test in-process samples
• Clean and sample equipment
• 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.

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, including ability to navigate enterprise software (ie Pilgrim, JDE, etc)
• Basic math skills
• Knowledge of aseptic manufacturing practices
• Knowledge of standard operating procedures, specifications, and job-specific training materials
• Requires the 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:

• Occasional (0-33%)
  • Sitting, climbing stairs and ladders, overhead reaching and/or lifting, balancing, kneeling, crouching, crawling, operating controls
  • Lifting and carrying up to 53 lbs
  • Pushing up to 105 lbs
  • Pulling up to 105 lbs
• Frequent (34-66%)
  • Standing, walking, reaching forward, stooping, object handling, fingering, fine hand coordination simple and firm hand grasping
  • Lifting and carrying up to 44 lbs
  • Pushing and pulling up to 15 lbs
• Constant (67-100%)
  • Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping
• Final candidates for Prep Operator 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.

Additional requirement(s):

• Education and experience: High School diploma or GED required, 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', job-specific training materials, GMP's, and other manuals.

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
  • 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
• 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 12/31/24

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 proud to be 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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