Process Validation Expert — Manufacturing Excellence

Novartis AG; Noord-Brabant; On-site; EUR 46,000 - 85,000; Full time

Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Job summary

Novartis AG in Baarle Nassau, Netherlands, seeks a Process Expert in Manufacturing Science & Technology to ensure robust, compliant validation across the product lifecycle. You'll drive validation activities, maintain inspection-ready state, and collaborate with cross-functional teams to manage risks and improvements.

The role requires 1–2 years in validation/manufacturing environments, a scientific degree, fluent English, and understanding of GMP processes.

Qualifications

• Bachelor’s degree in Pharmacy, Pharmaceutical Technology, Chemistry, or an equivalent scientific discipline.
• 1–2 years of experience in Validation, Manufacturing, Manufacturing Science & Technology, technical development, quality in a pharmaceutical or GMP environment.
• Good understanding of pharmaceutical manufacturing processes and associated process equipment and software.
• Experience supporting or executing process validation activities within a regulated environment.
• Fluent English; Dutch language proficiency is an advantage.
• Experience coordinating projects and collaborating with cross-functional teams to deliver objectives on time.
• Basic understanding of pharmaceutical analytical testing and its role in process and product quality.
• Strong problem-solving skills with the ability to manage multiple priorities in a multidisciplinary environment.

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

Dutch (advantage)

Cross-functional collaboration

Project coordination

Problem solving

Education

Bachelor’s degree in Pharmacy, Pharmaceutical Technology, Chemistry, or equivalent

Job description

Novartis AG in Baarle Nassau, Netherlands, seeks a Process Expert in Manufacturing Science & Technology to ensure robust, compliant validation across the product lifecycle. You'll drive validation activities, maintain inspection-ready state, and collaborate with cross-functional teams to manage risks and improvements.

The role requires 1–2 years in validation/manufacturing environments, a scientific degree, fluent English, and understanding of GMP processes.