Simtra BioPharma Solutions · 2 months ago
Process Validation Associate II
Bloomington, Indiana, United States
Full-time
Onsite
Mid, Senior Level
5+ years expSimtra BioPharma Solutions is a leading Contract Development Manufacturing Organization that partners with pharmaceutical and biotech companies to bring sterile injectable products to market. The Process Validation Associate II will execute process validation activities, develop validation strategies, and create necessary documentation while ensuring compliance with regulatory standards. This role requires effective communication and collaboration with clients and cross-functional teams at their Bloomington, Indiana facility.
BiopharmaManufacturingMedicalPharmaceutical
Responsibilities
Supports the process validation program
Interacts with the client and client team to define process validation scope
Designs and executes the appropriate development Technical Studies to define process parameters
Creates a risk assessment of the process to be validated
Creates process validation protocols
Conducts and coordinates process performance qualification (PPQ batch) execution for new and existing products
Prepares validation summaries
Uses statistical tools to analyze process validation data
Performs annual reviews / continued process verification (CPV) of validation projects
Investigates and executes validation related Corrective and Preventive Actions (CAPA)
Demonstrate ability to communicate effectively at all levels
Non-conformance Report (NCR) investigation owner for process validation related, as needed
Participates in regulatory, client and internal audits
Qualification
Required
BS degree, preferably in a science or engineering related field
5+ years pharmaceutical industry experience in parenteral manufacturing
Experience working independently or in a team
Knowledge of pharmaceutical manufacturing industry
Experience executing projects
Experience identifying opportunities for optimization of processes/projects
Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook)
Experience using enterprise software (i.e., JDE, Veeva, Trackwise, etc.)
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
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
2026-01-22
2026-01-20
Company data provided by crunchbase