Sterility Assurance Validation Associate ; 1st shift

About the Role

The Sterility Assurance Validation Associate I is responsible for managing and executing 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, 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 for client, corporate and regulatory auditors
• Conduct development studies on critical equipment
• Own and onboard 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
• Own non-conformance investigations (NCR)
• Own corrective and preventive actions (CAPA)
• Own 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
• Act as subject matter expert for up to 3 processes, technologies or process equipment
• Own, plan interventions and lead syringe line media fills and maintain 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 a 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 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
  • 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
  • Short and Long-Term Disability Insurance
  • 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

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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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.