Manager, Automation and Controls

Responsibilities

• Leadership & Team Management
• Lead, mentor, and develop a team of automation and controls engineers and technicians
• Establish team priorities, performance goals, and training plans
• Manage external system integrators, OEMs, and automation vendors
• Automation & Control Systems
• Oversee design, configuration, programming, commissioning, and lifecycle management of PLC, SCADA, DCS, HMI, and MES-integrated systems
• Supporting automation for pharmaceutical processes including batch, continuous and utilities systems
• Develop and maintain automation standards, templates, and best practices
• GMP Compliance & Validation
• Ensure automation systems comply with FDA, EMA, and global regulatory requirements
• Lead or support CSV activities including URS, FRS, SDS, FAT, SAT, IQ, OQ, and PQ
• Ensure data integrity compliance (ALCOA+) and 21 CFR Part 11 requirements
• Support regulatory inspections and internal audits
• Project Management
• Lead automation scope for capital projects, expansions, and tech transfers
• Manage project schedules, budgets, and risk related to automation deliverables
• Coordinate automation activities across engineering, quality, IT, and manufacturing
• Operational Support
• Provide escalation support for automation system issues impacting production
• Drive root cause investigations and CAPAs related to automation failures
• Support shutdowns, startups, and continuous improvement initiatives
• Cybersecurity & IT Integration
• Partner with IT and Quality to maintain secure industrial control systems
• Implement cybersecurity best practices aligned with ISA/IEC 62443
• Support system backups, disaster recovery, and change control
• Continuous Improvement & Digitalization
• Identify opportunities to improve process reliability, efficiency, and data visibility
• Support digital manufacturing initiatives, including advanced analytics and MES integration
• Evaluate emerging automation technologies for regulated environments
• Bachelor's degree in Electrical Engineering, Automation, Controls Engineering, or related field
• 10-12+ years of experience in automation and controls within a pharmaceutical or regulated manufacturing environment
• 2-5+ years of people management experience
• Strong experience with one of the system houses like Allen-Bradley, Foxboro & or Emerson DeltaV will be a must
• Experience in project management of >$2MM roll out design /implementation
• Proven experience with GMP validation and regulatory compliance
• Batch control systems and recipe management
• Industrial networking and system integration
• SDLC & CSV documentation and change management systems
• Demonstrated knowledge of 21 CFR Part 11, ISA, Data Integrity requirements for automated systems in the pharmaceutical industry
• Preferred
• Experience with biologics, sterile manufacturing, or cell and gene therapy
• Familiarity with MES, historians, and manufacturing execution systems
• Knowledge of GAMP 5, ISA-88, ISA-95
• PMP or similar project management certification
• Some familiarity with Industry 4.0 technologies and digital transformation
• Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

Benefits

Additional Information

The Manager of Automation and Controls is responsible for leading automation, control systems and instrumentation activities within GMP pharma manufacturing environment. This role ensures that automation systems are compliant, validated, reliable and aligned to regulatory requirements while supporting safe, efficient and high-quality production. The manager leads a team of automation professionals and partners closely with quality, manufacturing engineering, IT and external vendors. This position will also be responsible to manage workload and maintain/improve internal matrix. We are seeking a driven and technical oriented Manager- Automation and Controls to lead site design, implementation and maintenance of automation, controls systems and industrial networks to ensure safe, reliable and efficient operation. This role manages projects and technologies related to PLC, SCADA, DCS and instrumentation while driving continuous improvement, standardization and best practices. This role will lead and implement a site strategy in compliance with regulatory and AbbVie global expectations, champion key site initiatives, and contribute to the global Center of Excellence. Execute a vision of world class data governance that serves our patients by managing the site's efforts at driving best practices within the data lifecycle. This role is responsible for leading the design, implementation, maintenance and optimization of control systems and automation technologies across the facility.

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