Simtra BioPharma Solutions · 4 months ago
Process Engineer (multiple openings)
Bloomington, Indiana, United States
Full-time
Onsite
New Grad, Entry, Mid, Senior Level, Lead/Staff
0+ years expSimtra BioPharma Solutions is a leading Contract Development Manufacturing Organization that partners with pharmaceutical and biotech companies. They are seeking a Process Engineer responsible for developing, implementing, and optimizing manufacturing packaging processes to enhance efficiency and ensure compliance with safety and regulatory standards.
BiopharmaManufacturingMedicalPharmaceutical
Responsibilities
Demonstrates a strong ownership for the equipment and processes in the filling or packaging areas
Implement process improvement projects that enhance efficiency, improve quality, and reduce costs for aseptic filling processes, lyophilization, or inspection & packaging processes
Develop user requirements (URS), technical specification and design specifications for new processing (aseptic filling, lyophilization, equipment preparation, formulation) and/or automated inspection & packaging equipment and/or upgrades to existing equipment
Author and execute protocols to include commissioning, qualification, and validation activities (FAT, SAT, IQ and OQ) for packaging systems
Collaborates with external engineering firms or OEM in feasibility assessments, concept design, basic design, and detail design
Develop and maintain project schedules using MS Project
Collaborate with suppliers to source processing and/or packaging equipment parts to ensure quality standards are met
Provide technical support and training to operations and maintenance on aseptic processing equipment or inspection & packaging equipment
Interact with all functions and levels of management, ensuring effective, ongoing communication across teams and internal/external stakeholders
Support with complex site investigation of key safety and production issues and events and work on the identification and implementation of CAPA (Corrective and Preventive Action) plans to address such events and prevent recurrence
Qualification
Required
BS degree in Engineering (Chemical, Mechanical, Electrical, Packaging, Pharmaceutical, Biomedical), or a related technical field
0-2 years of experience (Level I)
2-5 years of experience (Level II)
5-8 years of experience (Level III/Sr.)
8-15 years of experience (Level IV/Principal)
15+ years of experience (Level 5 / Sr. Principal)
Knowledge of the basic principles in aseptic processing and/or packaging engineering best practices
Must be able to lead and execute engineering projects
Strong understanding of packaging materials, processing, and testing methods
Experience with PLC, HMI, Vision Systems and Building Management systems
Strong oral and written communication skills
Must be able to read mechanical, electrical, and P&ID drawings
AutoCAD or equivalent component design knowledge
Advanced proficiency in Microsoft Office Suite (Word, Excel, and Outlook)
Experience and the ability to use enterprise software (examples include: JDE, Microsoft Dynamics, BPLM, Veeva, Trackwise, etc.)
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
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
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