Sr. Process Automation and Controls Manager

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 Automation and Controls Manager is responsible for overseeing the design, implementation, and maintenance of process automation systems within pharmaceutical processing, packaging, and facilities to ensure compliance with strict regulatory standards (cGMP) by optimizing production efficiency, quality control, and data integrity through advanced process control technologies, while prioritizing safety and regulatory adherence across all automation initiatives. The Sr. Process Controls Automation Manager reports to the Director Engineering & Maintenance and is 100% onsite at the Bloomington, IN facility.

The responsibilities:

System Design and Implementation:

• Develop and execute process automation and controls strategies for new and existing pharmaceutical manufacturing processes, including selection of appropriate control systems and instrumentation
• Lead the design, configuration, and installation of process automation and controls systems, ensuring integration with existing infrastructure
• Manage project timelines, budgets, and resources for process automation and controls projects
• Responsible for the applications and migration to stand up a separate OT (Operational Technology) structure

Validation and Compliance:

• Ensure all automation systems are thoroughly validated according to industry standards and regulatory requirements (e.g., 21 CFR Part 11)
• Develop and execute validation protocols for automation systems, including IQ, OQ, and PQ phases
• Conduct risk assessments to identify potential issues within automation systems and implement mitigation strategies
• Work closely with the CSV team within Tech Services to support new and ongoing validations

Maintenance and Troubleshooting:

• Responsible for ongoing maintenance, troubleshooting, and support of process automation and controls systems
• Manage system upgrades and lifecycle management to ensure continued functionality and compliance

Quality Assurance:

• Monitor process data to identify deviations and initiate corrective actions
• Work closely with Quality Assurance (QA) to investigate manufacturing issues and implement corrective actions

Team Leadership:

• Manage a team of automation engineers (all levels) providing technical guidance and training
• Foster a culture of continuous improvement within the automation team

Required qualifications:

• BS in Engineering (Computer, Electrical, Computer Science, Systems Engineering and Design, or related field)
• 15 years of work experience in process automation and controls systems (including experience in programming of PLC, SCADA, and HMI systems) in pharmaceutical manufacturing
• 8 years managing/supervising team
• Strong project management skills
• Experience in reading and interpreting electrical schematics
• Experience and/or knowledge of Ignition SCADA/HMI
• Deep understanding of cGMP regulations and validation principles
• Proficiency in data analysis and reporting
• Excellent communication and collaboration abilities to work with cross-functional teams

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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