Senior Process Engineer

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 Senior Process Engineer is responsible for continuous improvement on equipment and processes by providing floor support and troubleshooting as required on specific equipment associated to formulation and filling, such as syringe filling machines, isolators, autoclaves and cleaning systems. This role also ensures that equipment is operating reliably and efficiently in order to meet production and quality standards. An Engineer will and Change Control protocols. This position will be responsible for managing projects (vendor relations, procurement, installation, and functional testing) and executing required documentation (work orders, change controls, SOPs) to achieve both budget and timeline requirements. This position reports to the Manager of Process Engineering.

The responsibilities:

• Implement improvement projects for equipment reliability, proactive maintenance, and process improvement
• Perform process reviews and prepare technical documentation detailing equipment operation and recommended changes
• Contribute to product transfer teams to meet Client timelines and expectations
• Develop and maintain project schedules
• Perform validation maintenance reviews of equipment
• Suggest and develop energy and time saving ideas and improvements
• Evaluate and recommend products and systems in key technology areas
• Prioritize tasks to resolve complex problems and execute non-conformance investigations and associated corrective actions
• Require little direction, works on technical projects, and has sufficient knowledge within area of functional responsibility (interpret prints and drawings, procure parts and set safety stock, define critical part functionality/requirements)
• 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 (Chemical, Mechanical, Electrical, or a related field)
• 5+ years of experience in pharmaceutical environment
• Ability to lead and execute various engineering projects (scope, change control, vendor management, etc.)
• Experience with depyrogenation tunnel, terminal sterilizers, autoclaves, lyophilizers, and cleaning equipment
• Experience in aseptic manufacturing environment preferred
• Experience with PLC, HMI, Vision Systems and Building Management
• Computer proficiency in MS Office Suite (Word, Excel, PowerPoint Outlook)
• Experience using enterprise software (i.e., JDE, BPLM, Pilgrim, Trackwise, etc.)
• Ability to read mechanical and electrical drawings

Physical / safety requirements:

• Must be able to lift up to 50lbs
• Duties may require overtime work, including nights and weekends
• Position requires sitting or standing for long hours
• Must be able to gown qualify for Grade A/B areas

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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