Process Engineer II

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 II that is responsible for developing, implementing, and optimizing pharmaceutical manufacturing (forming, filling, capping, 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.  This position reports directly to the Process Engineering Manager

The responsibilities:

• Develop User Requirement Specifications, Technical Specification and Design Specifications for new automated processing equipment or upgrades to existing equipment
• Author and executes protocols to include FAT, SAT, IQ and OQ
• Implement improvement projects for utilities and department processes
• Perform process reviews and prepare technical reports detailing equipment operation, best practices, and recommended changes
• Develop and maintain project schedules using MS Project
• Perform validation maintenance reviews of process and utility systems
• Suggest and develop energy-saving ideas and facility improvements
• Interpret building prints and utility drawings
• Evaluate and recommend products and systems in key technology areas
• Prioritize tasks to resolve complex problems
• Require little direction, works on technical projects, and has sufficient knowledge within area of functional responsibility
• Must have positive attitude, critical thinking and clear decision-making skills
• Must be able to multi-task, prioritize projects and complete projects on-time within budget

Desirable qualifications:

• BS in Engineering, required
• 3 - 5 years of experience in process engineering in the pharmaceutical industry
• Knowledge of the basic principles in various engineering disciplines
• Must be able to lead and execute engineering projects taking a robust and process optimization/reliability approach
• Preferred experience with filling machines (vial, syringe, cartridge), depyrogenation tunnel and lyophilizers
• Preferred experience in aseptic manufacturing environment
• Experience with PLC, HMI, Vision Systems and Building Management systems
• Computer proficiency in Microsoft Word, Excel, and Outlook
• Experience and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)
• Must be able to read mechanical and electrical drawings
• AutoCAD or equivalent component design knowledge 

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
  • 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 12/31/24

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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