Automation Integration Services (AIS) Senior Manager

Your tasks

The AIS Senior Manager is responsible for leading the Automation Integration Services function to ensure reliable, compliant, and efficient operation of site automation systems supporting Drug Substance (DS) and Drug Product (DP) manufacturing. This role provides operational leadership for automation activities, drives continuous improvement and digitalization initiatives, ensures GMP and regulatory compliance, and develops ahigh-performing automation team to support business growth and manufacturing excellence.

1. Provide operational leadership for the AIS organization, establishing and developing ahigh-performing automation team through effective talent development, coaching, succession planning, and performance management.

1. Lead the daily operation, monitoring, maintenance, and lifecycle management of process automation systems supporting DS and DP manufacturing, ensuring high system availability, reliability, and operational efficiency.

1. Ensure all automation operation, maintenance, troubleshooting, and change management activities are executed in accordance with approved SOPs, GMP requirements, Data Integrity principles, and site quality systems.

1. Establish and maintain automation standards, best practices, and performance metrics to improve system reliability and operational excellence.

1. Lead investigation, root cause analysis, and resolution of automation-related issues, ensuring timely closure of deviations, CAPAs, change controls, and configuration changes.

1. Drive digitalization, smart manufacturing, and process optimization initiatives to improve productivity, data visibility, operational efficiency, and manufacturing performance.

1. Ensure automation systems comply with GMP, EHS, Data Integrity, Cybersecurity, GAMP5,and applicable regulatory requirements.

1. Support Computer System Validation (CSV) activities and ensure validated state is maintained throughout the automation system lifecycle.

1. Act as the automation subject matter expert during internal audits, customer audits, corporate audits, and regulatory inspections, supporting audit readiness and timely closure of observations.

1. Partner with Manufacturing, Engineering, Quality, Validation, IT, Utilities, and Project teams to support operational and project objectives.

1. Provide technical leadership for automation projects, including design review, commissioning, qualification, startup, and handover activities.

1. Develop departmental objectives, budgets, resource plans, and long-term capability strategies aligned with site and corporate goals.

1. Perform other duties and responsibilities as assigned by management.

Requirements

Education

• Bachelor's Degree or above in Automation Engineering, Electrical Engineering, Instrumentation & Control, Chemical Engineering, Computer Engineering, or a related discipline.

• Minimum 8-10 years of automation, process control, or engineering experience in pharmaceutical, biotechnology, or other GMP-regulated manufacturing environments.
• Minimum 3-5 years of leadership experience managing automation, controls, or engineering teams.
• Experience supporting manufacturing operations, troubleshooting, and automation system lifecycle management.
• Experience participating in regulatory inspections and customer audits.

Technical Competencies

• Strong knowledge of industrial automation systems, including:
• DCS
• PLC
• SCADA
• HMI
• Historian Systems
• Building Management Systems (BMS)
• Hands-on experience with automation platforms such as:
• Emerson DeltaV
• Siemens PCS7 / TIA Portal
• Rockwell Automation
• Good understanding of:
• GMP regulations
• Data Integrity requirements
• GAMP5
• Computer System Validation (CSV)
• Change Control
• Deviation Management
• CAPA Processes
• Industrial Cybersecurity

Leadership Competencies

• Excellent leadership and team development skills.
• Strong communication, influencing, and stakeholder management abilities.
• Strong analytical thinking and problem-solving capability.
• Ability to manage multiple priorities in a fast-paced, highly regulated manufacturing environment.
• Demonstrated ability to lead cross-functional teams and drive organizational change.