Sr. Process Automation and Controls Manager

GQR; Bloomington (IN); On-site; USD 120,000 - 165,000; Full time

Job summary

A leading company in pharmaceutical manufacturing is seeking a Sr. Process Automation and Controls Manager to drive automation initiatives while ensuring compliance with regulatory standards. The ideal candidate will have extensive experience in process automation, team leadership, and a strong engineering background. This on-site role in Bloomington requires overseeing process automation across multiple projects to enhance production efficiency and maintain quality control.

Qualifications

• 15+ years in process automation and controls systems in pharmaceuticals.
• 8+ years in managing a team.
• Experience in reading and interpreting electrical schematics.

Responsibilities

• Oversee design and maintenance of process automation systems.
• Lead automation strategy execution for pharmaceutical manufacturing.
• Manage timelines, budgets, and resources for automation projects.

Skills

Automation

Leadership

Technical guidance

Continuous improvement

Regulatory compliance

Education

BS in Engineering (Computer, Electrical, Computer Science, Systems Engineering and Design)

Tools

PLC

SCADA

HMI systems

Ignition SCADA/HMI

Job description

Sr. Process Automation and Controls Manager

Sr. Process Automation and Controls Manager

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Title: Sr. Process Automation and Controls Manager

Location: On-site 5 days a week in Bloomington, IN.

This role does require at least 15 years of experience in Automation and at least 8 years of experience in a leadership role with direct reports, preferably in the pharmaceutical industry.

Overview

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.

Responsibilities:

• 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
• 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
• 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
• Monitor process data to identify deviations and initiate corrective actions
• Work closely with Quality Assurance (QA) to investigate manufacturing issues and implement corrective actions
• Manage a team of automation engineers (all levels) providing technical guidance and training
• Foster a culture of continuous improvement within the automation team

Required Skills:

• 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
• Experience in reading and interpreting electrical schematics
• Experience and/or knowledge of Ignition SCADA/HMI

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Product Management and Manufacturing

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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