Automation Specialist, GMP QC Lab Systems Lead

Johnson & Johnson Co.; Amsterdam; On-site; EUR 45,000 - 71,000; Full time

Benefits offered by this job

Annual bonus

Vacation & parental leave

Well-being programs

Insurance plans

Recognition awards

Job summary

Johnson & Johnson in the Netherlands is seeking an experienced Automation Specialist for QC laboratories. You will support data integrity, the validation of computerized systems, and LEAN improvements while ensuring GMP compliance.

You will perform investigations into quality records, define CAPAs, and collaborate with cross-functional groups to sustain product quality and regulatory adherence, including 21 CFR Part 11. English is essential; Dutch desirable.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• GMP knowledge and familiarity with FDA/EMA guidelines.
• 2+ years in pharmaceutical industry with GMP and automation experience.
• Hands-on software development experience and programming.
• GxP computerized system validation experience.
• Strong analytical and problem-solving skills; effective planning.
• Excellent English; Dutch desirable.
• Ability to build relationships across levels of the organization.

Responsibilities

• Lead the technical implementation of new laboratory systems with cross-functional teams.
• Create and maintain administrative, technical installation, and maintenance procedures.
• Provide timely support and troubleshoot issues involving computerized systems.
• Ensure equipment implementations comply with 21 CFR Part 11 requirements.
• Contribute to laboratory systems initiatives with the global organization and business needs.
• Support the team in resolving day-to-day technical challenges.
• Lead or support investigations into non-conformances involving systems and materials.
• Define, coordinate, and implement corrective/preventive actions and effectiveness checks.
• Act as a Subject Matter Expert and participate in inspections when required.

Skills

GMP knowledge

FDA/EMA guidelines

Pharma experience

Software development

Laboratory experience

Computerized system validation

Analytical skills

Problem solving

Planning

Prioritization

Stakeholder management

English proficiency

Dutch desirable

Analytical reasoning

Compliance management

Continuous improvement

Quality systems documentation

Data analysis

ISO 9001

Quality control

Report writing

Sample testing

Technologically savvy

Education

Bachelor’s degree (HBO) in Life Sciences, Computer Science, or equivalent experience

Job description

Johnson & Johnson in the Netherlands is seeking an experienced Automation Specialist for QC laboratories. You will support data integrity, the validation of computerized systems, and LEAN improvements while ensuring GMP compliance.

You will perform investigations into quality records, define CAPAs, and collaborate with cross-functional groups to sustain product quality and regulatory adherence, including 21 CFR Part 11. English is essential; Dutch desirable.