Simtra BioPharma Solutions · 10 hours ago
Process Technology Engineer
Bloomington, IN
Full-time
Onsite
Mid, Senior Level
5+ years expSimtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. The Process Technology Engineer will lead the specification, procurement, and qualification of equipment needed for client pharmaceutical filling operations, serving as a critical link between clients, internal teams, and vendors.
BiopharmaManufacturingMedicalPharmaceutical
Responsibilities
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
Qualification
Required
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
Experience working in a CDMO or client-driven manufacturing environment
Project Management Professional (PMP) certification
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
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
Company
Simtra BioPharma Solutions
Simtra BioPharma Solutions is a pharmaceutical company that manufactures injectables and clinical supplies.
1001-5000 employees
H1B Sponsorship
Simtra BioPharma Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (5)
Funding
Current Stage
Late StageTotal Funding
$0.5M2024-12-19Grant· $0.5M
Leadership Team
M
Mike Schaefers
Chief Commercial Officer (CCO) & Head of Business Development
Recent News
Inside INdiana Business
2025-09-23
Company data provided by crunchbase