Simtra BioPharma Solutions-posted 2 months ago
Full-time • Mid Level
Bloomington, IN
1,001-5,000 employees
Chemical Manufacturing

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 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)
  • Familiarity with isolators, RABS, lyophilizers, and related fill-finish equipment
  • Experience working in a CDMO or client-driven manufacturing environment
  • Project Management Professional (PMP) certification
  • 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
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Voluntary Insurance Benefits
  • Vision Coverage
  • Accident Insurance
  • Critical Illness Insurance
  • Hospital Indemnity Insurance
  • Identity Theft Protection
  • Legal Assistance
  • Onsite Campus Amenities
  • Workout Facility
  • Cafeteria
  • Credit Union
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