BS degree in Engineering (Chemical, Mechanical, Electrical, Packaging, Pharmaceutical, Biomedical) or related field
1+ years of experience in aseptic processes or inspection & packaging engineering
Knowledge of aseptic processing and packaging engineering best practices
Strong understanding of packaging materials, processing, and testing methods
Experience with PLC, HMI, Vision Systems, and Building Management systems
Ability to read mechanical, electrical, and P&ID drawings
Advanced proficiency in Microsoft Office Suite
Responsibilities
Demonstrate strong ownership of filling or packaging equipment and processes
Implement process improvement projects for aseptic filling and packaging
Develop user and design specifications for processing and packaging equipment
Author and execute commissioning and validation protocols
Collaborate with external engineering firms on design assessments
Maintain project schedules using MS Project
Interact with all levels of management and stakeholders
Benefits
Medical & Dental Coverage
Flexible Spending Accounts
401(k) Retirement Savings Plan with Company Match
Paid Holidays, Paid Time Off, Paid Parental Leave
Education Assistance Program
Employee Ownership Plan
Onsite campus amenities including workout facility and cafeteria
Full Job Description
This role:
We are looking for a Sr. 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
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.
