Process Engineer (multiple openings)

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 teamsso we can solve problems in new ways.

Make it RIGHT We hold ourselves to a high standard of excellencefulfilling 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 (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
  
  • 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.)

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 youll 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
  • 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.

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