Simtra BioPharma Solutions · 2 months ago
Sterility Assurance Validation Media Team Associate I (2nd Shift)
Bloomington, Indiana, United States
Full-time
Onsite
Mid, Senior Level
6+ years expSimtra BioPharma Solutions is a Contract Development Manufacturing Organization that partners with pharmaceutical and biotech companies to bring sterile injectable products to market. The Validation Media Team Associate I will lead media fills, manage intervention risk, and communicate with clients and auditors, ensuring high quality and regulatory standards are met.
BiopharmaManufacturingMedicalPharmaceutical
Responsibilities
Interacting directly with clients to evaluate new projects against the existing media fill process
Creating documentation (gap assessments, procedures, summary reports, etc.) to support media fills at the site. These documents will be reviewed by clients and regulatory auditors
Creating and executing visual smoke testing studies to evaluate new equipment and processes
Performing and authoring investigations, process improvements, and change controls
Participate in client audits and provide rationale for validation practices with support from senior Validation team members
Provide written responses to final audit observations
Serve as the subject matter expert for up to 3 processes, technologies or process equipment
Lead fill line media challenges by planning interventions, communicating plans with other departments, providing oversight in the Fill Room, and writing the summary of the media fill
Become trained and perform semi-annual HEPA filter certification testing (integrity testing, velocity testing, visible smoke testing)
Travel may be required as part of training, or equipment onboarding. Travel will be domestic and/or international
Qualification
Required
Minimum Bachelor's degree (preferably in science related discipline with laboratory experience) OR 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 executing studies, etc.)
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, TrackWise, Ellab Valsuite Pro, etc.)
Critical thinking and problem solving skills
High initiative and ability to deal with ambiguity
Attention to detail, ability to maintain organized workspace, and ability to communicate (oral and written)
Ability to work with cross-functional teams
Customer facing relations with external clientele
Team and individual goal oriented
Innovation and process improvement mindset
Ability to lift 50 pounds
Must be able to climb and work from ladders
Must be able to qualify for 20/25 corrected vision
Will require occasional overtime work, including nights and weekends
Use of hands and fingers to manipulate office equipment
Position requires standing for long hours but may involve walking or sitting for periods of time
Ability to meet Grade A and B gowning requirements
Ability to travel
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
Inside INdiana Business
2025-09-23
Company data provided by crunchbase