Process Technology 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 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.

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.

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.

• 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.)

• 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

• 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

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

• 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…