Simtra BioPharma Solutions · 1 day ago
Sterility Assurance Validation Associate I (1st Shift)
Bloomington, IN
Full-time
Onsite
Mid, Senior Level
6+ years expSimtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. The Sterility Assurance Validation Associate I is responsible for the management and execution of project qualifications and validation confirmations, ensuring compliance with regulatory agency requirements and internal standards.
HealthcarePharmaceuticalManufacturingBiopharmaMedical
Responsibilities
Document (protocols, SOPs, summary reports) new processes and update existing processes where vital that will be reviewed by clients, corporate and regulatory auditors
Conduct development studies on critical equipment
Owns and onboards new client projects, including the relevant validations on syringe lines
Serve as line owner, conducting gap assessments and determining validation approaches when onboarding new projects
Collaborates directly with client representatives
Owns non-conformance investigations (NCR)
Owns corrective and preventive actions (CAPA)
Owns change control management tasks (CCM)
Participates in client audits and provides rationale / justification for practices with aid from senior team member / management Responds to audit observations and owns deliverables
Subject matter expert for up to 3 processes, technologies or process equipment
Owns, plans interventions and leads syringe line media fills and has full ownership through closure of the summary
Owns & drives value improvement projects (VIP) to realize savings
Become trained and perform semi-annual HEPA filter certification testing (integrity testing, velocity testing, visible smoke testing)
Qualification
Required
BS degree in science related field with laboratory experience or High School diploma/GED with a minimum of 6 years related experience within a pharmaceutical, biotechnology or related industry including responsibilities comparable to this position (e.g., technical writing, audit experience, project lead, authoring and performing studies, etc.)
Microsoft Office Suite (Word, Excel, Outlook) intermediate proficiency
Ability to use enterprise software (JDE, BPLM, Pilgrim, Trackwise, Ellab Valsuite Pro, etc.)
Critical thinking and problem-solving skills
High initiative and ability to deal with ambiguity
Skills to interact professionally and collaboratively with the client representatives
Good writing skills - including technical writing
Strong oral and written communication - including communication with external clients
Ability to meet Grade A and B gowning requirements
Ability to lift 50 lbs
Must be able to climb and work from ladders
Duties will require some overtime work, including nights and weekends
Position requires standing for long hours, but may involve walking or sitting for periods of time
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.
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