Process Engineer

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 design services, 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—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.

This Role:

Process Engineer:
Simtra, Bloomington, Indiana.

Lead end-to-end project management for pharmaceutical engineering initiatives, overseeing specifications, budgeting, procurement, scheduling, installation, validation, and delivery of upgrades, repairs, and turnkey systems. Provide hands‑on manufacturing and regulatory support through equipment troubleshooting, IQ/OQ validation, investigations and CAPA authorship, change control and work order ownership, and SME participation in regulatory, client, and internal audits.

Required qualifications:

The minimum requirement is a Bachelors Degree in engineering and three years pharmaceutical experience as process engineer.

Experience must include: working in aseptic manufacturing environment;
Interfacing with PLC, HMI, Vision Systems and Building Management systems;
Ability to use enterprise software commonly used in pharmaceutical manufacturing operations;
Supporting filling machines involving sterile drug products, vile filling processes, lyophilization equipment, and associated manufacturing systems;
Reading mechanical and electrical drawings and Knowledge of AutoCAD or equivalent component design knowledge.

• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
  • Spouse Life Insurance
  • Child Life 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.

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…