Process Technology 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.

This role:

We are seeking a highly organized and technically proficient Process Technology Engineer to join our engineering team. This individual will be responsible for leading the specification, quoting, procurement, and qualification of equipment needed to support client pharmaceutical filling operations. The engineer will serve as the critical link between clients, internal technical teams, and vendors to ensure equipment integration into existing filling lines meets regulatory, operational, and commercial requirements.  This candidate reports to the Sr. Manager, Engineering & Maintenance and is 100% onsite at the Bloomington, Indiana facility.

The responsibilities:

Client Interface & Requirements Gathering

• Serve as the technical liaison with pharmaceutical clients to define equipment requirements for new or transferred products
• Translate client needs into functional equipment specifications compatible with existing fill-finish platforms (RABS, isolators, lyo, etc.)

Project Execution

• Lead the development of user requirement specifications (URS) and coordinate design reviews with vendors and internal stakeholders
• Generate equipment quotes, manage vendor relationships, and support capital budgeting and justification processes
• Drive the procurement process and track equipment delivery timelines

Equipment Implementation

• Coordinate installation, commissioning, and qualification (IQ/OQ/PQ) activities in alignment with GMP and client expectations
• Collaborate with operations, quality, and validation teams to ensure successful equipment startup and integration into production schedules

Communication & Documentation

• Provide regular updates to clients and internal leadership on project status, risks, and deliverables
• Maintain organized technical documentation and change control records for all projects

Continuous Improvement

• Support post-implementation reviews to drive equipment performance improvements and lessons learned for future projects

Required qualifications: 

• BS degree in Engineering (Mechanical, Chemical, Electrical, or related field)
• In lieu of education, 5+ years of experience in process technology/engineering in pharmaceutical industry
• 2+ years of experience in pharmaceutical manufacturing in equipment or process engineering\
• Strong understanding of fill-finish operations, aseptic processing, and GMP compliance
• Experience with capital equipment specification, procurement, and qualification
• Excellent communication and client-facing skills
• Proven ability to manage multiple concurrent projects and interface with cross-functional teams
• Proficiency in writing equipment validation protocols (IQ/OQ/PQ) or technical writing
• Advanced proficiency in Microsoft Office Suite (i.e., Word, Excel, PowerPoint, Outlook, Teams)
• Preferred familiarity with isolators, RABS, lyophilizers, and related fill-finish equipment
• Preferred experience working in a CDMO or client-driven manufacturing environment
• Preferred Project Management Professional (PMP) certification 

Physical / safety requirements:

• Duties may require overtime work, including nights and weekends
• Position requires sitting for long hours, but may also involve walking or standing for long periods of time
• Variable travel of 0-10% could be expected
• Must be able to lift, push, pull, and carry up to 50 lbs
• Must be able to lift 20 lbs overhead
• Must be able to wear personal protective equipment (PPE), as required

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 12/31/25

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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