Metrology Project Manager

Physiol; Luik; Sur place; EUR 70 000 - 110 000; Plein temps

Résumé du poste

Physiol is seeking a Metrology Project Manager to lead metrology and validation activities across new product development, industrialization, and manufacturing. The role ensures validated test methods, measurement systems, and production equipment, complying with quality and regulatory standards.

You will work with R&D, Industrialization, Production, Quality, and external partners to implement reliable measurement systems and validation processes that support product quality and successful

Qualifications

• Experience in metrology, validation, quality engineering in regulated manufacturing.
• Strong knowledge of IQ/OQ/PQ and computerized system validation (CSV).
• Experience with measurement systems, calibration principles, and statistical analysis (MSA).
• Knowledge of quality systems and applicable regulatory standards.
• Strong project management, planning, and organizational skills with cross-functional coordination.
• Excellent communication and collaboration across cross-functional teams.
• Strong attention to detail and ability to manage competing priorities.

Responsabilités

• Define, select, and implement measurement and control resources for manufacturing of products.
• Define calibration methods, measurement procedures, and sampling instructions for measurement equipment.
• Lead or coordinate validation of test methods, production equipment, processes, and CSV systems.
• Collaborate with R&D, Industrialization, Quality Assurance, Regulatory Affairs, and Production teams.
• Define, validate, and transfer quality control methods to Quality Control and Production teams.
• Prepare validation protocols, reports, and supporting documentation.

Connaissances

Project management

Planning

Organizational skills

Communication

Collaboration

Attention to detail

Description du poste

We are seeking a Metrology Project Manager to lead metrology and validation activities supporting new product development, industrialization, and manufacturing operations. This role is responsible for ensuring test methods, measurement systems, production equipment, manufacturing processes, and computerized systems are validated in compliance with applicable quality and regulatory requirements. Working closely with R&D, Industrialization, Production, Quality, and external partners, the Metrology Project Manager drives the implementation of reliable measurement systems and validation processes that support product quality, operational performance, and successful product commercialization.

Responsibilities

Metrology

• Define, select, and implement measurement and control resources to support the manufacturing of BVI products.
• Define calibration methods, measurement procedures, and sampling instructions for measurement equipment.
• Define specifications for measurement equipment acquisition projects and manage implementation through production release.

Validation & Quality Control

• Lead or coordinate the validation of test methods, production equipment, manufacturing processes, and computerized systems (IQ/OQ/PQ/CSV).
• Collaborate with R&D, Industrialization, Quality Assurance, Regulatory Affairs, and Production teams to validate new products, equipment, methods, and software.
• Define, validate, and transfer quality control methods to the Quality Control and Production teams.
• Develop control specifications, sampling instructions, and inspection methods for raw materials and components.
• Prepare validation protocols, reports, and supporting documentation, ensuring effective implementation within Quality Control and Production.
• Participate in technical assessments of contract laboratories supporting product and process verification and validation.
• Contribute to Measurement System Analysis (MSA) studies to evaluate measurement system accuracy, repeatability, reproducibility, and process capability.
• Collaborate with R&D and Industrialization teams to anticipate metrology and validation requirements for new products and manufacturing processes.
• Support the development and execution of product verification and validation activities.
• Participate in cross-functional project meetings to ensure alignment throughout product development.

Quality System

• Report non-conformities and quality-related issues to the relevant managers and Quality Assurance.
• Escalate any events that could impact product quality, regulatory compliance, or the successful execution of assigned activities.

Qualifications

• Experience in metrology, validation, quality engineering, or a related role within a regulated manufacturing environment.
• Strong knowledge of validation methodologies, including IQ/OQ/PQ and computerized system validation (CSV).
• Experience with measurement systems, calibration principles, and statistical analysis (e.g., MSA).
• Knowledge of quality systems and applicable regulatory standards.
• Strong project management, planning, and organizational skills, with the ability to coordinate multiple activities and stakeholders.
• Excellent communication and collaboration skills, with the ability to work effectively across cross-functional teams.
• Strong attention to detail, a quality-focused mindset, and the ability to work independently while managing competing priorities.