Validation Engineer

Real; Boxmeer; Presencial; EUR 65 000 - 90 000; Tempo integral

Resumo da oferta

Real, a leading pharmaceutical organization, seeks a Senior Validation & Calibration Specialist to join its Operational Services team in Boxmeer, Netherlands. This on-site role coordinates, executes, reviews, and reports validation, qualification, and calibration activities within a GMP manufacturing environment.

The ideal candidate will act as SME, work with engineering, operations, quality, and suppliers; ensure compliance, documentation, audits support, and continuous improvement.

Qualificações

• Bachelor's degree in Engineering, Life Sciences, or related discipline.
• Minimum 5 years in pharma or GMP-regulated environment.
• Proven validation, qualification, and calibration experience.
• Strong GMP knowledge and documentation skills.
• Fluent Dutch and English; Dutch mandatory.

Responsabilidades

• Develop, review, and maintain validation, qualification, and calibration protocols.
• Prepare and review technical reports and annual plans.
• Coordinate validation and calibration activities per GMP.
• Review qualification documentation and technical packages.
• Perform data analysis and maintain records in quality/CMMS systems.
• Act as SME for validation topics.
• Support deviation investigations and change control.
• Collaborate with engineers, operations, quality and suppliers.
• Drive continuous improvement and procedural enhancements.
• Support audits and regulatory inspections.
• Ensure GMP, safety, quality and environmental standards.

Conhecimentos

Analytical skills

Problem-solving

Independent working

Documentation skills

Formação académica

Bachelor's degree in Engineering/Life Sciences/Pharma

Ferramentas

CMMS systems

Document control systems

Validation software

Descrição da oferta de emprego

Senior Validation & Calibration Specialist

Start: ASAP

Duration: 12 months (with intent to extend)

Location: Boxmeer, Netherlands (100% On-site)

Hours: Full-time (40 hours per week)

Sector: Pharmaceutical Manufacturing / GMP / Validation / Calibration / Engineering

About the Role

A leading pharmaceutical organization is looking for an experienced Senior Validation & Calibration Specialist to join its Operational Services team. In this position, you will be responsible for coordinating, executing, reviewing, and reporting validation, qualification, and calibration activities within a GMP-regulated manufacturing environment.

You will act as a technical expert and work closely with engineering, operations, quality, suppliers, and process owners. In addition to technical activities, you will play a key role in compliance, documentation, process improvement, and supporting audits and inspections.

This is not a junior-level position. The successful candidate should be able to quickly operate independently and make an immediate contribution to the team.

Key Responsibilities

• Develop, review, and maintain validation, qualification, and calibration protocols.
• Prepare and review technical reports, documentation, and annual plans.
• Coordinate and execute validation and calibration activities in accordance with GMP requirements.
• Review qualification documentation and technical packages.
• Perform data analysis and maintain records within quality and CMMS systems.
• Act as Subject Matter Expert (SME) for validation, qualification, and calibration-related topics.
• Support deviation investigations and change control activities.
• Collaborate with internal stakeholders, engineering teams, and external suppliers.
• Drive continuous improvement initiatives and procedural enhancements.
• Support internal and external audits and regulatory inspections.
• Ensure compliance with GMP, safety, quality, and environmental standards.

Who We Are Looking For

You are an experienced validation professional who thrives in a pharmaceutical GMP environment. You have strong technical and documentation skills, work accurately, and can independently manage complex technical activities. In addition, you are comfortable interacting with a wide range of stakeholders and supporting business-critical operations.

Must-Haves

• Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Technology, or a related discipline.
• Minimum 5 years of experience within the pharmaceutical industry or another GMP-regulated environment.
• Proven experience with validation, qualification, and calibration processes.
• Strong knowledge of GMP regulations and compliance requirements.
• Experience writing and reviewing technical documentation and reports.
• Good command of both Dutch and English.
• Fluent Dutch is mandatory due to Dutch-language SOPs, work instructions, and reporting requirements.
• Strong analytical and problem-solving skills.
• Ability to work independently and take ownership of projects and technical topics.

Preferred

• Experience with autoclaves and sterilization processes.
• Experience with temperature mapping and thermal validation activities.
• Knowledge of process equipment qualification.
• Experience with deviation investigations and change control processes.
• Familiarity with CMMS systems.
• Previous experience serving as a Subject Matter Expert (SME).
• Experience supporting audits and regulatory inspections.
• Experience within large pharmaceutical manufacturing environments.