Process Expert, Manufacturing Science & Technology

NL42 (FCRS = NL042) IDB Holland BV; Baarle-Nassau; On-site; EUR 46,000 - 85,000; Full time

Benefits offered by this job

Performance bonus

Hybrid work options

Parental leave (14 weeks)

Comprehensive benefits

Job summary

Novartis in Baarle Nassau, Netherlands seeks a Validation specialist to develop and maintain validation master plans for manufacturing, cleaning, and packaging. You will execute lifecycle activities, review records, and support process verification while ensuring compliance.

Ideal candidates have 1–2 years of validation/quality experience in pharma, strong GMP knowledge, and fluent English with Dutch as an advantage.

Qualifications

• 1–2 years in Validation, Manufacturing, MSE/T, technical development or quality in pharma/GMP
• Fluent English; Dutch a plus
• Understanding of pharma manufacturing processes and equipment

Responsibilities

• Develop and maintain validation master plans for manufacturing, cleaning, packaging and verification.
• Execute validation lifecycle activities and support ongoing process verification.
• Author, review and approve validation protocols, reports and documentation.
• Support on-floor validation activities to ensure timely completion.
• Review Master Batch Records and change controls for revalidation needs.
• Maintain validation activities in an inspection-ready state.
• Facilitate risk assessments and apply risk management principles.
• Collaborate cross-functionally to manage process risks.
• Manage deviations and recommend CAPAs.
• Translate critical process parameters into validation plans.

Skills

Change Controls

Cleaning Validations

Continual Improvement

Data Analytics

Emotional Resilience

Good Documentation Practices

Health, Safety & Environment

Manufacturing Processes

Manufacturing Production

Operational Excellence

Process Control

Process Validation

Quality Control

Regulatory Compliance

Risk Management

Education

Bachelor's degree in Pharmacy

Bachelor's or equivalent in Pharmaceutical Technology

Chemistry or equivalent scientific discipline

Job description

Salary Range: 45.900,00 € - 85.300,00 € Job Description Summary #LI-Onsite Location: Baarle Nassau, Netherlands Relocation Support: This role is based in Baarle Nassau, Netherlands. Novartis is unable to offer relocation support: please only apply if accessible.

Job Description Key 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.

Essential Requirements

• 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 Good Manufacturing Practice 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; proficiency in Dutch 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.

Benefits & Rewards

At Novartis, we're committed to reimagining medicine together - and rewarding the people who make it happen.

Expected Annual Base Salary Range for role: € 45,900 to € 85,300. The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically. In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave. Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics. Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.

Commitment to Diversity and Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Skills Desired

Change Controls, Cleaning Validations, Continual Improvement Process, Data Analytics, Emotional Resilience, Good Documentation Practices, Health, Safety, and Environment (HSE) Policy, Manufacturing Processes, Manufacturing Production, Operational Excellence, Process Control, Process Validation, Quality Control (QC), Regulatory Compliance, Risk Management

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.