Simtra BioPharma Solutions · 20 hours ago
Quality Engineer
Bloomington, IN
Full-time
Onsite
Mid LevelSimtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies. The Quality Engineer is responsible for equipment and system validation, qualification, and change control by collaborating with cross-functional teams to ensure compliance and quality standards.
BiopharmaManufacturingMedicalPharmaceutical
Responsibilities
Provides guidance and technical expertise in interpreting regulatory and Simtra requirements in validation strategy and processes
Quality signatory responsible for providing leadership, guidance, quality oversight and approval of commissioning, qualifications, and validations related to equipment utilized in the manufacturing of pharmaceutical drug products
Interfaces with Engineering, Technical Services, Manufacturing and Regulatory personnel as well as other technical disciplines to determine change control requirements. Assist and support the equipment and system validation activities
Conducts assessments of quality systems, identifies and closes gaps related to validation and corporate procedures
Guides peers, validation and engineering in the use of sound, statistically based quality engineering approaches in project and test planning and in the analysis and interpretation of test results. Studies and recommends improvements to existing products/processes
Qualification
Required
Bachelor's degree in engineering
Preferred
Experience working in a cGMP environment
American Society of Quality (e.g., CQE, CMQ/OE, etc.) and/or Six Sigma certification
Computer proficiency in Microsoft Word, Excel, and Outlook
Ability to use enterprise software (examples include: JDE, BPLM, 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
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
Company
Simtra BioPharma Solutions
Simtra BioPharma Solutions is a pharmaceutical company that manufactures injectables and clinical supplies.
Founded in 1930
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