Clinical Manufacturing Operator

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.

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This role:

The Clinical Manufacturing Operator is responsible for executing all tasks associated with the production of drug products in the Clinical manufacturing area. Activities include aseptic filling line setup and operation, formulation of drug products, lyophilizer use, cleaning/sanitization of area and equipment, and adhering to current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) standards. The Clinical Manufacturing Operator may be required to cross-train to support other areas of manufacturing as needed to support the business and will work in and maintain a Grade C/D environment. This position reports to the Operations Specialist - Clinical Manufacturing.

The responsibilities:

• Understand and follow current Good Manufacturing Practices
• Perform routine operations utilizing formulation and filling equipment in Grade C/D areas and Grade A filling isolator
• Utilize computer software and HMI (Human Machine Interface) to control automated equipment
• Troubleshoot process problems and respond to process alarms.
• Complete calculations to determine the amount of material to add based on final weight and sometimes potency
• Retrieve and test in-process samples
• Perform routine cleanup and sanitizations assigned by area supervision to maintain cGMP compliance within the Grade A/B/C/D work areas. Perform sanitizations in a timely and effective manner in accordance with cGMPs and Baxter procedures, maintaining production schedule.
• Always maintain organization within the classified areas to ensure equipment segregation, readiness and to prevent any contamination or rejection of batches
• Perform environmental monitoring; including fingertip, contact, and fallout plates as required
• Assist in the training and development of other team members on processes in which they are qualified

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 work in a confined/clustered work space.

Desirable qualifications:

• High school diploma or GED required.
• 2 years of experience operating and troubleshooting complex production equipment preferred
• 1 year pharmaceutical manufacturing related experience preferred
• Knowledge of cGMP manufacturing preferred
• Knowledge of basic laboratory and pharmaceutical production equipment including, but not limited to: filling machines, autoclaves, weight scales, pallet wrappers, etc. preferred
• Prior work in clean room environments (ISO 5/7/8, Grade A/B/C/D) preferred
• Knowledge, assembly, and operation of filling machines and filtration systems preferred.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software preferred (examples include: JDE, BPLM, MAXIMO, Trackwise, etc.)

Physical / safety requirements:

• Ability to stand for extended periods of time
• Ability to lift up to 50 pounds
• Ability to push/pull heavy wheeled objects (ie: tanks, carts, pallet jacks, etc.)
• Must be able to perform overhead work (ie: sanitizing walls and ceilings)
• Physical coordination/flexibility to allow gowning for clean room environments
• Utilize applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear and hearing protection
• Dexterity and physical condition to perform some level of repetitive motion tasks
• Ability to wear respirator usage when product or task requires
• Eyesight to ensure effective inspection of equipment and/or filled units (corrective lenses acceptable)
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Must be able to gown qualify for Grade C/D areas.

Additional requirements:

• 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
  • 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 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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