Manager, Automation and Controls

Company Description Abb Vie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and provide products and services in our Allergan Aesthetics portfolio. Job Description

The Manager of Automation and Controls is responsible for leading automation, control systems and instrumentation activities within a 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.

Responsibilities:

• 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.
• Oversee design, configuration, programming, commissioning, and lifecycle management of PLC, SCADA, DCS, HMI, and MES-integrated systems.
• Support automation for pharmaceutical processes including batch, continuous and utilities systems.
• Develop and maintain automation standards, templates, and best practices.
• 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.
• 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.
• 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.
• 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.
• 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.
• 12–15+ years of experience in automation and controls within a pharmaceutical or regulated manufacturing environment.
• 3–5+ years of people management experience.
• Strong experience with PLC, SCADA, DCS, and batch control systems.
• Proven experience with GMP validation and regulatory compliance.
• PLC/DCS platforms (e.g., Rockwell, Siemens, Emerson, Fox Boro).
• Batch control systems and recipe management.
• Industrial networking and system integration.
• CSV documentation and change management systems.
• Demonstrated knowledge of 21 CFR Part 11, ISA, Data Integrity requirements for automated systems in the pharmaceutical industry.

• Experience with biologics, sterile manufacturing, or cell and gene therapy.
• Familiarity with MES, historians, and manufacturing execution systems.
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Knowledge of GAMP 5, ISA-88, ISA-95.
• PMP or similar project management certification.
• Some familiarity with Industry 4.0 technologies and digital transformation.

Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.