Sr Process Automation and Controls Manager

Simtra BioPharma Solutions (Simtra) is a worldclass 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 prefilled syringes liquid/lyophilized vials diluents for reconstitution powderfilled 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 lifechanging 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 daytoday 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 crossfunctional teams

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 LongTerm 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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