Automation Project Manager

Lead the automation strategy behind large-scale biopharmaceutical projects and turn complex systems into operational excellence.

R&D Partners is seeking an Automation Project Manager to lead the planning, execution, and delivery of automation systems for large-scale capital projects within a biopharmaceutical manufacturing environment. This role is critical in ensuring the successful integration of automation platforms, regulatory compliance, and seamless transition of systems to Operations while managing project scope, budget, schedule, and vendor performance.

Applicants must have legal authorization to work in the United States.

Responsibilities:

• Coordinate the integration of automation systems across Distributed Control Systems (DCS), Programmable Logic Controllers (PLCs), Manufacturing Execution Systems (MES), Electronic Batch Records (EBR), data historians, and site infrastructure.
• Collaborate with engineering, manufacturing, quality, validation, IT-OT, and system owners to deliver integrated automation solutions.
• Ensure compliance with cGMP requirements, ALCOA data integrity principles, cybersecurity standards, and company automation standards throughout the project lifecycle.
• Lead automation activities from design through commissioning, qualification, validation, and operational handover.
• Manage automation-related project scope, schedules, budgets, forecasts, and vendor commitments to ensure successful project delivery.
• Identify, assess, and mitigate project risks while providing timely resolution of automation-related issues.
• Drive successful automation handover to Operations and system owners by ensuring documentation is complete, training is delivered, and operational readiness criteria are achieved.
• Provide clear, concise executive-level communication on project status, key risks, critical decisions, and trade-offs.
• Support regulatory inspections, audits, and validation activities related to automation systems.
• Ensure automation systems comply with applicable industry standards, validation requirements, and corporate governance.

Key Skills and Requirements:

Required Qualifications:

• Bachelor’s degree in Engineering, Automation, Electrical Engineering, Chemical Engineering, Computer Engineering, or a related technical discipline.
• 8-15 years of experience delivering automation solutions within biopharmaceutical manufacturing or other regulated industries.
• Demonstrated experience leading automation execution on large capital projects.
• Strong understanding of GMP automation, Computer System Validation (CSV), data integrity (ALCOA), and regulatory inspection requirements.
• Proven experience managing multidisciplinary teams, contractors, and automation vendors.
• Excellent project management, leadership, and stakeholder management skills.
• Strong written and verbal communication skills with the ability to present effectively to executive leadership.

Technical Knowledge:

• Distributed Control Systems (DCS)
• Programmable Logic Controllers (PLCs)
• Manufacturing Execution Systems (MES)
• SCADA and HMI systems
• Electronic Batch Records (EBR)
• Data historians
• Industrial networking and OT infrastructure
• ISA-88 and ISA-95 standards
• FAT, SAT, IQ, OQ, and PQ
• Cybersecurity for industrial automation environments

Regulatory Compliance Knowledge:

• Current Good Manufacturing Practices (cGMP)
• ALCOA Data Integrity Principles
• Computer System Validation (CSV)
• GAMP 5
• 21 CFR Part 11
• Change Control and CAPA processes
• Regulatory inspection readiness

Core Competencies:

• Automation Project Management
• Cross-functional Leadership
• Strategic Planning and Execution
• Budget and Forecast Management
• Vendor and Contract Management
• Risk and Issue Management
• Executive Communication
• Operational Readiness
• Problem Solving and Decision Making
• Continuous Improvement

For more information, please contact Jack Keens.

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

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