Sr Process Engineer - Clinical Manufacturing

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:

The Sr Process Engineer - Clinical Manufacturing supports the day-to-day operations of the clinical production area, including floor support, equipment operation, and maintenance. The role provides direct technical/process support as a Subject Matter Expert (SME) for the clinical line and equipment through line maintenance and troubleshooting, vendor relations, procurement, and validation.

The position reports directly to the Operations Specialist - Clinical Manufacturing, and functions as a management designee based on organizational needs. The position requires interaction across multiple departments, including heavy engagement and communication within DPCS, various Quality functions, Engineering and Maintenance, and Technical Services teams, as well as with clients. Communication skills, experience with root-cause-analysis tools, and understanding of aseptic manufacturing are a must.

The responsibilities:

• Provide daily technical support for clinical production equipment and systems
• Troubleshoot and maintain equipment such as vial/syringe fillers, isolators, lyophilizers, and formulation systems
• Lead equipment performance reviews and identify opportunities for process optimization
• Coordinate preventive maintenance and vendor support
• Author technical reports, studies, and documentation to support investigations and improvements
• Support tech transfers and collaborate with cross-functional teams
• Apply Lean/Six Sigma tools to drive operational excellence

The work environment:

• Hands-on work in Grade A-D cleanroom environments
• Ability to lift up to 50 lbs and wear PPE, including respirators
• Flexibility for occasional nights/weekends and extended standing/walking

Required qualifications:

• Bachelor's degree in Engineering, Science, or related field
• 3+ years of experience in pharmaceutical manufacturing or technical support
• Strong understanding of GMP and aseptic processing
• Experience with process equipment and onboarding
• Proficiency in tools like Maximo, Trackwise, and Veeva
• Excellent communication and root-cause analysis skills

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
  • Employee Ownership Plan
  
  
  
  
• 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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