Sterility Assurance Validation Associate I

Simtra BioPharma Solutions (Simtra) is a worldclass 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 prefilled syringes liquid/lyophilized vials diluents for reconstitution powderfilled 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 lifechanging 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 teamsso we can solve problems in new ways.

Make it RIGHT We hold ourselves to a high standard of excellencefulfilling our commitments to the customer their patients and our team members.

Make it COUNT We take pride in our daytoday work knowing the impact we make taking on challenges big and small to improve patient health.

This role:

The Sterility Assurance Validation Associate I is responsible for the management and the 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.

The responsibilities:

• 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
• Collaborates directly with client representatives
• Owns nonconformance investigations (NCR)
• Owns corrective and preventive actions (CAPA)
• Owns change control management tasks (CCM)
• Participates in client audits and provides rationale / justification for practices with aid from senior team member / management Responds to audit observations and owns deliverables
• Subject matter expert for up to 3 processes technologies or process equipment
• Owns plans interventions and leads syringe line media fills and has full ownership through closure of the summary
• Owns & drives value improvement projects (VIP) to realize savings
• Become trained and perform semiannual HEPA filter certification testing (integrity testing velocity testing visible smoke testing)

Required qualifications:

• 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 problemsolving 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

Physical / safety requirements:

• 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

In return youll be eligible for 1:

• 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 LongTerm 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 Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
• Additional Benefits
  • 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

1 Current benefit offerings are in effect through 12/31/25

Disclaimer

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.

Equal Employment Opportunity

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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