Sr. Sterility Assurance Validation Technician (1st shift)

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.  

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 life-changing 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 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.

 

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This role:

We are looking for a Senior Validation Technician (1st shift) with a can-do attitude that is self-sufficient and can bring new ideas and a great work ethic to an established Sterility Assurance Team! The Sterility Assurance Senior Validation Technician must have good technical knowledge to perform routine and non-routine validations, confirmations, and help support the Technicians and Validation Associates. The Technician will help ensure all systems are running correctly and efficiently to produce high quality products. This position reports to the Sterility Assurance Validation Associate III, is 1st shift, and is 100% onsite at the Bloomington, Indiana facility

 

Its responsibilities:

• Performs validation studies on pharmaceutical equipment and processes to prove successful operation and to ensure equipment remains in qualified state
• Performs, leads, and documents validations/qualifications on a variety of pharmaceutical equipment - including, but not limited to: environmental chambers, terminal sterilizers, autoclaves, lyophilization chambers, depyrogenation tunnels, vial washers, filling machines, sterilization tanks, and container / closure integrity studies, etc.
• Uses equipment/instruments and computer systems to collect critical data used to create reports for the validation studies
• Works with biological indicators, endotoxin indicators and other tools to demonstrate proper operation of manufacturing equipment
• Follows written procedures during validation studies, performing steps accurately and chronologically
• Maintains and generates accurate and complete records, reports and documentation
• Performs calibrations of data logging equipment and sensors
• Participates in semi-annual HEPA filter certification testing (integrity testing, velocity testing, visible smoke testing)
• Revise procedures and forms and improve Sterility Assurance Validation processes
• Assist with routing validation documentation for approvals

 

Desirable qualifications:

• High School diploma or equivalent
• 0-2 years relevant experience in validation, technical services, and/or working in a pharmaceutical manufacturing environment
• Intermediate (or higher) proficiency in Microsoft Office Suite (Word, Excel, and Outlook)
• Ability to use enterprise software (i.e., Trackwise, JDE, Ellab)
• Attention to detail, ability to maintain organized workspace, and ability to communicate (oral and written)
• Ability to work with cross-functional teams

 

Physical / Safety Requirements:

• Ability to lift 50 lbs
• Must be able to climb and work from ladders
• Must be able to qualify for 20/25 corrected vision
• Duties will require occasional overtime work, including nights and weekends
• Position requires standing for long hours but may involve walking or sitting for periods of time
• Ability to meet Grade A and B gowning requirements

 

In return, you’ll 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 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 Program
  • Community and Volunteer Service Program
• 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 12/31/24

 

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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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