Simtra BioPharma Solutions · 1 week ago
Validation (CQV) Engineer II
Bloomington, IN
Full-time
Onsite
Entry, Mid Level
2+ years expSimtra BioPharma Solutions is a leading Contract Development Manufacturing Organization focused on bringing sterile injectable products to market. The Validation (CQV) Engineer II will be responsible for developing documentation for CQV activities, writing and executing protocols, and ensuring compliance with cGMP and regulatory requirements while maintaining a state of audit readiness.
BiopharmaManufacturingMedicalPharmaceutical
Responsibilities
Develop documentation for CQV activities (URS, Trace Matrix, IQOQ Protocols etc)
Write and execute protocols (field verification)
Develop summary reports and analyze results to ensure compliance with cGMP and regulatory requirements
Track validation activities and accurately report out on progress and anticipated timelines
Manage change controls and assess for validation impacts
Continuously interact with all levels of management ensuring effective, ongoing communications across teams and stakeholders
Anticipate potential conflict situations and manages to a successful outcome
Assist Project Manager to ensure identification and communication of projects risks, development of risk plan, and leads team in the proactive management of risk response strategies
Assist Project Managers to create/maintain project schedules and track team deliverables for project completion
Participates in Internal/Client/Corporate/Regulatory Agency audits
Qualification
Required
BS degree in an Engineering or Science discipline
2+ years experience in commissioning, qualification, and validation in a regulated industry
Familiarity with ISPE Baseline Guide 5
Experience managing multiple projects in different stages at the same time
Strong technical writing skills
Advanced proficiency in Microsoft Office Suite
Preferred
Facilities and equipment startup
Fill equipment (Pre-filled Syringe filler, vial filler, Lyos)
Walk-downs and troubleshooting
Utilities (WFI, Clean Steam, HVAC)
Building automation
Pharmaceutical manufacturing processes
Computer system validation
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
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.
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