Senior Quality Engineer

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.

 

 

The role:

The Senior Quality Engineer is responsible for Quality oversight and approvals for Change Control, Requirements, Technical Specifications, Design Specifications, and Validation protocols. This position reports to the Manager of Quality.

 

The responsibilities:

• · Provides guidance and technical expertise in interpreting regulatory and Baxter requirements in validation strategy and processes.
• · Approves change documentation for new equipment or upgrades to existing equipment.
• · Approves protocols to include FAT, SAT, IQ and OQ.
• · Provides leadership, guidance, quality oversight and approval of commissioning, qualifications, and validations related to equipment utilized in the manufacturing of pharmaceutical drug products.
• · Conducts assessments of quality systems, identifies and closes gaps related to validation and corporate procedures.
• · Suggest cost saving ideas and facility improvements.
• · Prioritize tasks to resolve complex problems.
• · Require little direction, works on technical projects, and has sufficient knowledge within area of functional responsibility.
• · Must have positive attitude, critical thinking and clear decision making skills.
• · Must be able to multi-task, prioritize projects and complete projects on-time within budget.

 

The requirements:

• · Bachelors’ degree in Engineering required.
• · 3 years engineering experience, preferably in the pharmaceutical industry
• · Knowledge of the basic principles in various engineering disciplines
• · Prior experience in aseptic manufacturing environment preferred.
• · Quality Engineer certification preferred (e.g., CQE, etc.)
• · Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software

 

Physical / Safety Requirements

• · Must be able to wear appropriate personal protective equipment, including gowning for Grade C
• · Duties may require occasional overtime work, including nights and weekends.
• · Use of hands and fingers to manipulate office equipment is required
• · Position requires sitting or standing for long hours and may involve walking and standing in production or mechanical area

 

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
  • 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

[1] Current benefit offerings are in effect through 12/31/26

 

 

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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