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Sr. Process Automation and Controls Manager

Baxter Pharmaceutical Solutions, LLC

Indiana, Bloomington (PA, IN)

On-site

USD 90,000 - 130,000

Full time

15 days ago

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Job summary

An established industry player is seeking a Sr. Process Automation and Controls Manager to lead automation initiatives in pharmaceutical manufacturing. This role emphasizes compliance with regulatory standards while optimizing production efficiency and ensuring data integrity. The ideal candidate will have extensive experience in process automation, project management, and team leadership. You will be part of a dedicated team focused on delivering high-quality healthcare solutions, contributing to the development of life-changing medicines. Join this innovative firm and make a significant impact in the healthcare sector.

Benefits

Medical & Dental Coverage
401(k) Retirement Savings Plan with Company Match
Paid Time Off
Education Assistance Program
Employee Assistance Program
Community and Volunteer Service Program
Onsite Workout Facility
Onsite Cafeteria

Qualifications

  • 15+ years in process automation and controls in pharma.
  • Strong project management skills and team leadership experience.
  • Deep understanding of cGMP regulations and validation principles.

Responsibilities

  • Oversee design and maintenance of automation systems.
  • Ensure compliance with cGMP and validation protocols.
  • Manage a team of automation engineers and foster improvement.

Skills

Process Automation
Project Management
Data Analysis
Communication Skills
Team Leadership

Education

BS in Engineering

Tools

PLC Programming
SCADA Systems
HMI Systems
Ignition SCADA/HMI

Job description

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.



Data Privacy


To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:https://simtra.com/privacy-policy/

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