Sterility Assurance Validation Media Team Associate I (2nd Shift)

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington Indiana US and Halle/Westfalen Germany we offer a wide range of delivery systems including pre-filled syringes liquid/lyophilized vials diluents for reconstitution powder-filled vials and sterile crystallization.

Our product types include biologics and small molecules cytotoxics highly potent compounds diluents for reconstitution and vaccines which are all directly injected into patients worldwide. As such there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing we offer many support services including formulation and development lyophilization optimization global regulatory support and secondary packaging. Our teams are driven to help clients scale innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra Because we:

Make it HAPPEN We bring a growth mindset to every opportunity developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER We work as one respecting each voice and tapping into our unique strengths across teamsso we can solve problems in new ways.

Make it RIGHT We hold ourselves to a high standard of excellencefulfilling our commitments to the customer their patients and our team members.

Make it COUNT We take pride in our day-to-day work knowing the impact we make taking on challenges big and small to improve patient health.

This role:

We are looking for a Validation Media Team Associate I with a can-do attitude that is self-sufficient has a great work ethic and can bring new ideas to an established Sterility Assurance Team!

The Media Team Associate will lead media fills own the intervention risk management program and communicate directly with clients and auditors. This position reports to the Supervisor Sterility Assurance Validation.

The 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.

Required qualifications:

• Minimum Bachelors 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

Physical / safety requirements:

• 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

In return youll be eligible for 1:

• Day One 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
• Additional Benefits
• 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

1 Current benefit offerings are in effect through 12/31/25

Disclaimer

This job description is intended to provide the minimum knowledge skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race color religion gender national origin age sexual orientation gender identity or expression protected veteran status disability/handicap status or any other legally protected characteristic.

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