Process Engineer I - Packaging

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? Because we:

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 looking for a Process Engineer I - Packaging that is responsible for developing, implementing, and optimizing automated inspection and 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 pharmaceutical automated inspection & packaging areas. This position is 100% onsite at the Bloomington facility and reports directly to the Process Engineering Manager.

The responsibilities:
• Demonstrate a strong ownership for the equipment and processes in the filling or packaging areas you support
• Implement process improvement projects that enhance efficiency, improve quality and reduce costs for automated inspection & packaging processes
• Identify and implement new equipment and tooling as needed in support of new product launches
• Develop user requirements (URS), technical specification and design specifications for new 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
• Participates in collaborations with external engineering firm 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 automated inspection & packaging equipment
• Continuously interacts with all functions and levels of management ensuring effective, ongoing communications across teams and stakeholders
• Support with complex sites investigation of key safety and production issues and events and work on the identification and implementation of CAPA plans to address such events and prevent recurrence

The qualifications:
• BS degree in Engineering (Chemical, Electrical, Mechanical, Packaging, Pharmaceutical, Biomedical), or a related technical field
o 0-2 years of experience in automated inspection & packaging of pharmaceuticals

Knowledge of the basic principles in inspection and 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, P&ID and electrical 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: 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 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 pounds
• Must be able to lift 20 pounds overhead
• Must be able to wear personal protective (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.

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.

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