Senior Quality Engineer - GMP Compliance & Validation

Senior Quality Engineer | Engineering, Validation & Maintenance (EVM)

Job Description
A leading global pharmaceutical and biotechnology organisation is seeking a Senior Quality Engineer to join its Engineering, Validation & Maintenance (EVM) department at a major vaccine manufacturing and development site in the Netherlands. This position plays a critical role in ensuring GMP compliance, validation excellence, and continuous process improvement across engineering, maintenance, utilities, laboratory, and production environments.

Reporting to the Compliance Supervisor, the Senior Quality Engineer will provide leadership and support for the continuous improvement of internal and external business processes. The role focuses on quality and GMP‑related aspects of engineering, maintenance, qualification, and validation activities, ensuring compliance with pharmaceutical regulations and internal quality standards while driving operational excellence initiatives throughout the organisation.

The successful candidate will act as a subject matter expert in validation and quality systems, facilitate process excellence projects, support CAPA and deviation management, conduct audits, monitor performance metrics, and serve as the primary Quality representative within the EVM department.

Qualifications

Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Installation Technology, Process Engineering, or a related technical discipline

Minimum 4–8 years of experience in a similar Quality Engineer position, or several years of GMP experience with relevant Quality and Process Excellence project involvement

Strong understanding of GMP requirements, including validation and qualification activities for pharmaceutical and/or bioprocessing equipment, utilities, and facilities

Experience supporting quality and compliance activities within engineering, maintenance, validation, or technical operations environments

Knowledge of pharmaceutical industry regulations and guidelines, including FDA, GMP, ICH, ASTM, ISPE, and related standards

Experience in Process Excellence methodologies and continuous improvement initiatives

Strong communication and stakeholder management skills with the ability to build relationships across multiple departments

Experience supporting investigations, CAPAs, deviations, events, and quality system processes

Ability to conduct and follow up on internal audits

Strong analytical skills and experience with risk assessments and problem‑solving methodologies

High degree of accuracy, initiative, independence, and organisational capability

Quality‑focused mindset with the ability to work effectively in a regulated GMP environment

Fluent professional communication skills in a multidisciplinary setting

Preferred Requirements

Yellow Belt and/or Green Belt certification in Lean Six Sigma methodologies

Experience with in biotechnology, pharmaceutical, or process industry environments

Experience working within maintenance or engineering organisations supporting GMP operations

Expertise in Process Excellence tools and methodologies

Experience implementing and maintaining performance metrics, dashboards, and trend analysis systems

Ability to support multiple technical teams with process optimisation and continuous improvement initiatives

Strong troubleshooting capabilities and analytical thinking

Flexible and adaptable approach with the ability to manage changing priorities

Proactive, critical‑thinking mindset with a strong "can‑do" attitude

Commitment to continuous improvement of people, processes, and organisational performance

Practicalities

Start Date:

ASAP

Contract Type: 1 year

Department:
Engineering, Validation & Maintenance (EVM)

Reporting To:
Compliance Supervisor

Industry: Vaccines, Biotechnology & Pharmaceutical Manufacturing

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