Sterility Assurance Validation Associate I (1st shift)

<p><em>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. &nbsp;</em></p> <p><em>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. &nbsp;As such, there is a strong emphasis on quality and continuous improvement at Simtra. &nbsp;We hold ourselves to the highest quality and regulatory standards.</em></p> <p><em>While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.</em>&nbsp; <em>Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.</em></p> <p><strong>&nbsp;</strong></p> <p><strong>Why join Team Simtra?</strong><strong> </strong><strong>Because we:</strong></p> <p>Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.</p> <p>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.</p> <p>Make it RIGHT – We hold ourselves to a high standard of excellence,&nbsp;fulfilling our commitments to the customer, their patients, and our team members.</p> <p>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.</p> <p>&nbsp;</p> <hr> <p>&nbsp;</p> <p><strong>This role:</strong></p> <p>The Sterility Assurance Validation Associate I is responsible for the management and the execution of project and system qualifications, and validation confirmations including equipment and processes. The Validation Associate I ensures compliance that meets worldwide regulatory agency requirements, internal company standards/best practices and current industry practices. This position is 100% onsite at the Bloomington facility and reports to the Sr. Technical Services Validation Manager.</p> <p><strong>&nbsp;</strong></p> <p><strong>The&nbsp;responsibilities:</strong></p> <ul> <li>Document (protocols, SOPs, sum