Simtra BioPharma Solutions · 2 months ago
Computer Systems Validation Associate II
Bloomington, Indiana, United States
Full-time
Onsite
Mid Level
3+ years expSimtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization specializing in sterile injectable products. The Validation Associate II plays a crucial role in the Computer Systems Validation team, ensuring compliance with regulatory standards and leading validation processes for software applications in a GMP environment.
BiopharmaManufacturingMedicalPharmaceutical
Responsibilities
Validation document author/reviewer – VP, URS, FS/DS, TM, IQ, OQ, PQ using established templates
Technical writing proficiency – VP, URS, FS/DS, TM, IQ, OQ, PQ using established templates
Entitlement Reviews – Coordinates user access reviews for recertification and authorization
Local Change Control owner
CSV periodic reviews – to maintain the validated state, the Associate will perform periodic reviews of validation packages per established procedures
Validation lead GAMP Category 1 - 4
Client audits – The Associate will participate in client audits, responding verbally to auditor’s questions
Global Change Control task owner
System assessments – Quality, Regulatory, Risk, Gap CAPA owner
NCR/SNCR investigator
Validation Lead for implementation of major and minor software applications or modules for Good Manufacturing Practices (GMP) use
Completes detailed risk assessment and 21 CFR part 11 Gap analysis
Maintains departmental compliance with regulations and corporate procedures
Coordinates computer systems implementation activities with Vendors and other non-BPS resources
Creates/Reviews validation documentation, templates, procedures, and all documentation generated during a computer systems validation project
Participates in Internal/Client/Corporate Audits
Represents validation department as validation expert in cross-functional work teams
Advocates and understands best practices for system validations and processes
Articulates complex systems and communicates to technical and nontechnical management
Qualification
Required
BS in Electronic or Software Engineering, Information Systems, or a related field
3+ years experience of working within a regulated environment (worldwide regulatory agencies), particularly in computer systems validation or other validation discipline
Ability to use enterprise software (i.e., ERP, EDMS, QMS, JDE, Trackwise, etc.)
Experience with Microsoft Project
Technical writing skills
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
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