Sterility Assurance Validation Associate ; 1st Shift

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.

• 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 - 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 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.

• Document (protocols, SOPs, summary reports) new processes and update existing processes where vital that will be reviewed by clients, corporate and regulatory auditors.
• Conduct development studies on critical equipment.
• Owns and onboards new client projects, including the relevant validations on syringe lines.
• Serve as line owner, conducting gap assessments and determining validation approaches when onboarding new projects.
• Collaborate directly with client representatives.
• Owns non-conformance investigations (NCR).
• Owns corrective and preventive actions (CAPA).
• Owns change control management tasks (CCM).
• Participate in client audits and provide rationale/justification for practices with aid from senior team member/management. Respond to audit observations and own deliverables.
• Subject matter expert for up to 3 processes, technologies or process equipment.
• Own and plan interventions and lead syringe line media fills and has full ownership through closure of the summary.
• Own and drive value improvement projects (VIP) to realize savings.
• Become trained and perform semi-annual HEPA filter certification testing (integrity testing, velocity testing, visible smoke testing).

• BS degree in science related field with laboratory experience or High School diploma/GED with 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 performing studies, etc.).
• Microsoft Office Suite (Word, Excel, Outlook) intermediate proficiency.
• Ability to use enterprise software (JDE, BPLM, Pilgrim, Trackwise, Ellab Valsuite Pro, etc.).
• Critical thinking and problem-solving skills.
• High initiative and ability to deal with ambiguity.
• Skills to interact professionally and collaboratively with the client representatives.
• Good writing skills - including technical writing.
• Strong oral and written communication - including communication with external clients.

• Ability to meet Grade A and B gowning requirements.
• Ability to lift 50 lbs.
• Must be able to climb and work from ladders.
• Duties will require some overtime work, including nights and weekends.
• Position requires standing for long hours, but may involve walking or sitting for periods of time.

• 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…