Process Specialist – Clinical Manufacturing

Overview

Process Specialist – Clinical Manufacturing in Bloomington, Indiana, United States.

Simtra Bio Pharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization focused on providing sterile injectable products, with facilities in Bloomington, IN and Halle/Westfalen, Germany. We offer a 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.

There is a strong emphasis on quality and continuous improvement, with focus on cGMP manufacturing and support services such as formulation and development, lyophilization optimization, regulatory support and secondary packaging. Our teams aim to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Our values:
Make it HAPPEN, Make it TOGETHER, Make it RIGHT, Make it COUNT.

The Process Specialist – Clinical Manufacturing plays a critical role in supporting the daily operations of the clinical production area, including training, equipment operation and team leadership oversight. As a Subject Matter Expert (SME), you will provide direct technical and process support for clinical manufacturing lines and assist in the successful transfer of products into production. This position serves as a management designee based on production needs and requires strong cross-functional collaboration with departments such as DPCS, Quality, Engineering, Maintenance, Technical Services, and client teams.

• Develop expertise in filling line processes and equipment, including syringe and vial handling, filling, stoppering, capping, and tray loading.
• Become SME across multiple manufacturing areas:
  Preparation, Filling, Formulation, Capping, and Lyophilization.
• Delegate and coordinate scheduled activities and team members; spend 80% of time in-room/on the floor.
• Collaborate with Quality to ensure compliance and operational flexibility.
• Support product technical transfers into the Clinical production area.
• Assist in developing and reviewing batch records for new and existing projects.
• Monitor documentation in logbooks and batch records.
• Partner with EHS to uphold safety and sustainability standards.
• Apply Lean/Six Sigma tools to drive process improvements and foster a culture of continuous improvement.
• Lead or participate in investigations to resolve complex issues and implement corrective actions.
• Analyze process trends to identify improvement opportunities in equipment, efficiency, and yield.
• Standardize and train on set-up and troubleshooting procedures.
• Coach and mentor Production Operators on specialized tasks.
• Maintain Grade A/B aseptic gowning certification and successful media fill performance.

• Ability to lift up to 50 lbs.
• Willingness to work overtime, including nights and weekends.
• Extended periods of standing, walking, and working in Grade A-D environments.
• Manual dexterity for equipment manipulation.
• Ability to wear a respirator or PAPR.

• Bachelor’s Degree or equivalent experience preferred.
• Minimum 5 years of experience in pharmaceutical manufacturing or technical support.
• Strong understanding of Good Manufacturing Practices (GMP).
• Experience with process equipment or onboarding preferred.
• Proficiency in Microsoft Word, Excel, Outlook, and enterprise systems (e.g., Maximo, Trackwise, Veeva).
• Ability to work effectively in hands-on environments, including Grade C/D classified areas.

• 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

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 proud to be an equal opportunity employer.