Simtra BioPharma Solutions
Process Technology Engineer
Simtra BioPharma Solutions, Bloomington, Indiana, United States, 47401
2 days ago Be among the first 25 applicants
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? 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.
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
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.
Data Privacy To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://simtra.com/privacy-policy/
#J-18808-Ljbffr
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? 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.
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
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.
Data Privacy To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://simtra.com/privacy-policy/
#J-18808-Ljbffr