Validation Director

Simtra Bio Pharma 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  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.

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.

The Bloomington facility is a full-service contract manufacturing plant providing formulation, aseptic filling and finishing services. The Validation Director is a member of the plant senior leadership team and is responsible for the Validation functions. This position reports to the Site Director.

This position is on site 5 days per week in Bloomington, Indiana

• Lead the Validation organization supporting the manufacturing operations from Commissioning and Qualification through Performance Qualification. The teams comprising the organization are Sterility Assurance Validation, Cleaning Validation, Computer Systems Validation and Commissioning and Qualification.
• Deploy Validation strategies in compliance with global regulatory requirements
• The Validation disciplines are responsible for designing and validating processes for new equipment and new client drug products onboarded, maintaining the validated status for GMP processes throughout the facility, and representing Simtra in client and regulatory inspections.
  • There are currently 3 manufacturing facilities with 5 active filling lines and supporting process equipment. 1 clinical scale fill machine will be added in the next 18 months.
  • 1 additional manufacturing facility is currently undergoing commissioning and qualification with 1 isolated syringe line. 1 more syringe line and 1 vial line with 3 lyophilizers is in plan
  • 1 other manufacturing facility is in the early construction phases with plans for another 6+ filling lines likely within a 5-7 year period
• Direct the development and implementation of new processes requiring new technologies
• Budget development and ownership (>$10MM)
• Responsible for final approval on product / process documentation, including CAPAs, deviation investigations and change controls
• Responsible for strategic planning, deployment, execution and after-action reviews
• Represent the site during regulatory inspections, client visits, and internal audits
• Collaborate with site Quality to drive improvements and risk…