Process Specialist – Clinical Manufacturing

Simtra BioPharma Solutions • Bloomington, IN

92d

About The Position

The Process Specialist – Clinical Manufacturing plays a critical role in supporting the daily operations of the clinical production area. This includes 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.

Requirements

• 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.

Responsibilities

• 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 closely with Quality and 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.

Benefits

• 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
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program
• Community and Volunteer Service Program
• Employee Ownership Plan
• 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

What This Job Offers

• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees