Simtra BioPharma Solutions · 3 months ago
Process Specialist – Clinical Manufacturing
Bloomington, Indiana, United States
Full-time
Onsite
Senior Level
5+ years expSimtra BioPharma Solutions is a leading Contract Development Manufacturing Organization that partners with pharmaceutical and biotech companies. The Process Specialist – Clinical Manufacturing plays a vital role in supporting daily operations in clinical production, focusing on training, equipment operation, and providing technical support for manufacturing lines.
BiopharmaManufacturingMedicalPharmaceutical
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
Qualification
Required
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
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
Voluntary Insurance Benefits
Vision Coverage
Accident
Critical Illness
Hospital Indemnity Insurance
Identity Theft Protection
Legal and more
Workout Facility
Cafeteria
Credit Union
Company
Simtra BioPharma Solutions
Simtra BioPharma Solutions is a pharmaceutical company that manufactures injectables and clinical supplies.
1001-5000 employees
H1B Sponsorship
Simtra BioPharma Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (5)
Funding
Current Stage
Late StageTotal Funding
$0.5M2024-12-19Grant· $0.5M
Leadership Team
M
Mike Schaefers
Chief Commercial Officer (CCO) & Head of Business Development
Recent News
Inside INdiana Business
2025-09-23
Company data provided by crunchbase