Senior Automation CSV Engineer

We are searching for the best talent for Computerized System Validation (CSV) Execution Lead.

Purpose: The CSV Execution Lead leads validation and qualification activities for automation, digital, and GMP-relevant systems across capital projects and day-to-day operations. The scope covers modernized and legacy manufacturing equipment, laboratory equipment, utilities, facilities, infrastructure, and computerized systems. The work spans new implementations, upgrades, re-qualifications, lifecycle changes, periodic reviews, and inspection preparation.

As the Automation SME for CSV, this person plans, coordinates, and delivers validation work. They also coach validation engineers and act as a core or extended team member on projects. The role works closely with Engineering, Quality, Manufacturing, C&Q, IT, and project teams. Together, they make sure systems are delivered and maintained in line with company standards, regulatory requirements, and industry best practice.

You will be responsible for:

• Leading CSV and qualification across the full system lifecycle, from implementation and upgrades through periodic review and retirement.
• Defining risk-based validation strategies in line with GAMP 5, and developing, reviewing, and approving validation deliverables.
• Integrating Data Integrity (DI) standards into CSV workflows, templates, and deliverables in partnership with the Data Integrity Lead, including supporting remediation of legacy systems.
• Supporting lifecycle governance for automation systems, including the system inventory, configuration management, periodic reviews, and OT cybersecurity and patching under change control.
• Leading change impact assessments, deviation investigations, and CAPAs for validated systems.
• Keeping validation documentation inspection-ready, and acting as a main contact for validation topics during regulatory and third-party inspections.
• Managing CSV scope, estimates, resources, and workload across projects, and maintaining the CSV work catalogue to drive standardization.
• Partnering cross-functionally and coaching validation engineers on CSV and compliance, in line with the Johnson & Johnson Credo and Leadership Imperatives.

Qualifications / Requirements:

Required:

• Bachelor's or Master's degree in Engineering, Automation, Computer Science, Information Technology, Life Sciences, or a related discipline.
• 5+ years of experience in a GMP-regulated pharmaceutical, biotechnology, or medical device environment, including hands-on qualification and CSV work.
• Strong knowledge of cGMP, validation lifecycle principles, GAMP 5, DI expectations, ALCOA+, EU GMP Annex 11, and 21 CFR Part 11.
• Experience with GMP-relevant manufacturing, laboratory, or facility systems such as DeltaV, PLC, SCADA, and MES, including their interfaces, electronic records, and data flows.
• Proven ability to develop, review, and approve qualification and validation documentation, including user requirements, risk assessments, protocols, reports, traceability, deviations, CAPAs, and change controls.
• Proven ability to lead validation work across several projects at once and to coordinate cross-functional stakeholders and external suppliers.
• Strong analytical, risk-based, problem-solving, and root cause analysis skills, with the ability to make sound and defensible decisions.
• Excellent communication, technical writing, and stakeholder management skills in a cross-functional, international environment, including engaging with leadership and inspectors.
• Experience coaching, mentoring, and developing technical team members.
• Strong organizational, planning, and prioritization skills, with the ability to manage competing demands while meeting compliance and delivery commitments.
• Fluent written and spoken English.

Preferred:

• Experience supporting audits and regulatory inspections.
• Knowledge of OT cybersecurity practices, such as ISA/IEC 62443.

Preferred Skills:

Analytical Reasoning, Artificial Intelligence (AI), Controls Compliance, Cross-Functional Collaboration, Industry Analysis, Innovation, Lean Supply Chain Management, Machine Learning (ML), Project Management, Prototyping, Robotic Automation, Science, Technology, Engineering, and Math (STEM) Application, Scope Management, Systems Development, Technologically Savvy, Testing

Hybrid work