Sterility Assurance Validation Media Team Associate I

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 teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling 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 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

 

Physical / safety requirements: