CSV Automation Lead – Validation & GMP Systems

Biopharma Careers; Leiden; Remote; EUR 54,000 - 85,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave (min 12 weeks)

Well-being programs

Job summary

Johnson & Johnson Leiden seeks a Senior Automation CSV Engineer to lead validation across the full system lifecycle for automation, digital, and GMP-relevant systems. You will define risk-based validation strategies, implement DI-aligned CSV workflows, and coach engineers while coordinating with cross-functional teams.

The role starts with a 12-month contract with intent to convert to permanent, working closely with Engineering, Quality, Manufacturing, IT, and project teams to meet regulatory

Qualifications

• Bachelor's or master's degree in Engineering, Automation, Computer Science, Information Technology, Life Sciences, or related discipline.
• 5+ years in a GMP-regulated pharmaceutical/biotechnology environment with hands-on CSV work.
• Strong knowledge of cGMP, GAMP 5, DI expectations, ALCOA+, EU GMP Annex 11, and 21 CFR Part 11.

Responsibilities

• Lead CSV and qualification across the full system lifecycle, from implementation to retirement.
• Define risk-based validation strategies in line with GAMP 5 and develop, review, and approve validation deliverables.
• Integrate Data Integrity standards into CSV workflows and deliverables with the Data Integrity Lead.
• Support lifecycle governance for automation systems, including OT cybersecurity and patching under change control.
• Coach validation engineers and act as a main contact for inspections and regulatory interactions.

Skills

Analytical reasoning

Cross-functional collaboration

Project management

Problem solving

Education

Bachelor's or Master's degree in Engineering

Tools

DeltaV

PLC

SCADA

MES

Job description

Johnson & Johnson Leiden seeks a Senior Automation CSV Engineer to lead validation across the full system lifecycle for automation, digital, and GMP-relevant systems. You will define risk-based validation strategies, implement DI-aligned CSV workflows, and coach engineers while coordinating with cross-functional teams.

The role starts with a 12-month contract with intent to convert to permanent, working closely with Engineering, Quality, Manufacturing, IT, and project teams to meet regulatory