This role:
We are looking for a Process Engineer (level depends on experience) that is responsible for developing, implementing, and optimizing manufacturing packaging processes to improve efficiency, quality, and productivity. This engineer will work closely with cross-functional teams to identify areas for process improvement, troubleshoot issues, and ensure compliance with safety and regulatory standards in the pharmaceutical aseptic manufacturing or automated inspection & packaging areas. This position is 100% onsite at the Bloomington facility and reports directly to the Sr. Manager, Engineering & Maintenance.
The 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
Required qualifications:- BS degree in Engineering (Chemical, Mechanical, Electrical, Packaging, Pharmaceutical, Biomedical), or a related technical field
- 1+ years of experience in aseptic processes or inspection & packaging engineering in the pharmaceutical industry (level hired for depends on years of experience)
- 0-2 years of experience (Level I)
- 2-5 years of experience (Level II)
- 5-8 years of experience (Level III/Sr.)
- 8+ years of experience (Level IV/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.)
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[1]
:- Day One Benefits
- Medical & Dental Coverage
- Flexible Spending Accounts
- Life and AD&D Insurance
- Supplemental Life Insurance
- Spouse Life Insurance
- Child Life 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
- Employee Ownership Plan
- Additional Benefits
- Short and Long-Term Disability Insurance
- 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 12/31/26
DisclaimerThis 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.
