Automation Lead - DeltaV

Job Description – Automation Lead (DeltaV)

Location: Puerto Rico

Role Overview

We are seeking a seasoned Automation Lead to spearhead automation activities for a new drug substance manufacturing facility. The ideal candidate will bring deep expertise in Emerson DeltaV DCS systems, strong commissioning and validation experience, and proven leadership in managing automation teams through complex pharmaceutical projects.

Key Responsibilities

• Lead automation strategy, design, and execution for the new facility build.
• Oversee DeltaV Batch configuration, hardware/software integration, and system validation.
• Drive FAT, SAT, commissioning, and qualification activities ensuring compliance with GMP and regulatory standards.
• Collaborate with cross-functional teams (engineering, QA, validation, manufacturing) to align automation deliverables with project milestones.
• Manage automation engineers and contractors, providing technical guidance and mentoring.
• Ensure robust documentation practices (URS, FDS, IQ/OQ/PQ) aligned with GAMP5 and 21 CFR Part 11.
• Support troubleshooting, change management, and continuous improvement initiatives post-handover.

Required Skills & Experience

• 10+ years of experience in pharmaceutical automation projects.
• Strong hands-on expertise with Emerson DeltaV Batch (S88 standards).
• Proven track record in FAT, SAT, commissioning, and validation of automation systems.
• Experience in new facility builds or greenfield projects is highly desirable.
• Solid understanding of GMP, GAMP5, and regulatory compliance frameworks.
• Demonstrated team leadership and project management capabilities.
• Excellent communication and stakeholder management skills.

Preferred Qualifications