Process Validation Expert – Manufacturing Science

Novartis; Baarle-Nassau; On-site; EUR 46,000 - 85,000; Full time

Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Flexible work options

Parental leave

Job summary

Novartis in Baarle Nassau, Netherlands, is seeking a Process Expert in Manufacturing Science & Technology to ensure robust, compliant, and inspection-ready manufacturing processes. The role centers on validation activities across the lifecycle and collaboration with cross-functional teams to deliver high-quality medicines.

You will develop and execute validation plans, review protocols and reports, and help drive continuous improvement while adapting to regulatory requirements.

Qualifications

• Bachelor's degree in Pharmacy, Pharmaceutical Technology, Chemistry, or an equivalent scientific discipline.
• 1–2 years of experience in Validation, Manufacturing, MS&T, technical development, quality in pharma/GMP.
• Good understanding of pharmaceutical manufacturing processes and related equipment/software.
• Experience supporting or executing process validation in regulated environments.
• Fluent English; Dutch is an advantage.
• Experience coordinating projects with cross-functional teams to meet timelines.
• Basic understanding of pharmaceutical analytical testing and its role in quality.
• Strong problem-solving skills and ability to handle multiple priorities.

Responsibilities

• Develop and maintain validation master plans for manufacturing, cleaning, packaging, and ongoing verification activities.
• Execute process validation lifecycle activities and support ongoing process verification to maintain process control.
• Author, review, and approve validation protocols, reports, and verification documentation.
• Support execution of validation activities on the manufacturing floor and ensure timely completion.
• Review Master Batch Records and change controls to assess revalidation requirements.
• Maintain validation activities and projects in a continuous inspection-ready state.
• Facilitate risk assessments and apply quality risk management principles to validation activities.
• Collaborate cross-functionally to identify, assess, control, and document process risks.
• Manage process validation deviations and recommend effective corrective and preventive actions.
• Support process control strategies and translate critical process parameters into validation plans.

Skills

Fluent English

Project coordination

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in Pharmacy, Pharmaceutical Technology, Chemistry, or related science

Job description

Novartis in Baarle Nassau, Netherlands, is seeking a Process Expert in Manufacturing Science & Technology to ensure robust, compliant, and inspection-ready manufacturing processes. The role centers on validation activities across the lifecycle and collaboration with cross-functional teams to deliver high-quality medicines.

You will develop and execute validation plans, review protocols and reports, and help drive continuous improvement while adapting to regulatory requirements.