GMP Equipment Manager, Biopharm CMC

Labcorp is expanding its global BioPharmaceutical Chemistry, Manufacturing and Control (CMC) footprint and is opening a new CMC facility in Mechelen, Belgium.

Biopharmaceutical CMC provides independent, objective GMP analytical testing for manufactured medicinal products from late discovery through post-market approval on behalf of global clients. With a strong portfolio of clients and over 25 years of expertise the BioCMC team provides advanced characterization, method development, stability and routine QC release for biologics, vaccines, ATMP's, and a breadth of other complex biomolecules.

With this new laboratory in Belgium, we aim to offer a more comprehensive solution and accelerate the availability of new products for patients. The new site has been strategically developed to complement our existing capabilities in York and Harrogate (UK), and Greenfield (US) and introduce a new CMC analytical testing solution for commercial drug products in the European Union (EU).

This expansion is a key milestone in our long-term plan to strengthen support for pharmaceutical and biotechnology partners who rely on Labcorp for complex CMC and regulatory testing services. If you would like to join us and be a part of this exciting journey, take a look at the fantastic opportunities we have to offer.

• Standing, bending, reaching, and lifting laboratory equipment.
• Working in cold environments (e.g., LN2 vessels) and warm areas (e.g., stability storage).

• Lead, mentor, and develop the Mechelen site Equipment Management team to deliver high-quality, compliant support.
• Serve as SME during internal, client, and regulatory audits
• Oversee equipment maintenance, calibration, qualification, and lifecycle activities in accordance with GMP and departmental standards.
• Implement proactive risk management strategies to reduce equipment downtime and operational disruptions.
• Partner closely with cross-functional groups including Operations, QA, IT, Business Systems Implementation, and GMP Compliance.
• Onboarding equipment; includes HPLC, UPLC, ICE/Maurice, PA800+,
• Proficient in System Lifecycle process and be fully familiar with all required documentation to onboard and maintain equipment within the Biopharm CMC teams
• Responsible for the metric measurement and performance of the EM team in delivery to internal and external clients
• Owns and supports others with quality investigations, CAPA and change control assessments as required. Accountable for the approval of quality documentation in the team
• Resolves issues impacting internal or external customers as appropriate and ensures appropriate communication and collaboration is executed
• Responsible for the management of SOP updates and ensuring team are up to date with current procedures to execute their duties
• Ensures knowledge and practice of EHS requirements for selves and team and ensure team works to requirements appropriately.
• Leads process improvement and harmonization projects relating to EM processes.
• Oversight of supporting subcontractors in quality and performance, manage vendors to repair, service and maintain equipment as per required cycles
• Will contribute and may lead on broader projects within the scope of their role
• Performs any other reasonable duties as required

• Minimum BSc (Hons) Science degree
• Minimum of 5 years of experience within an equipment management position, including qualification and validation experience.
• Minimum 5 years of demonstrated experience in a leadership role
• Previous experience and knowledge of working in GMP regulatory laboratory or manufacturing environment
• Experience with CMC testing equipment
• Fluency in English and Dutch

• Higher level qualification and/or equipment management /regulatory qualifications
• Experience of equipment validation/qualification
• Experience with laboratory set-up and initiation in a GMP regulated environment

• Strong understanding of equipment lifecycle management, calibration, and compliance requirements.
• Good computing skills, including proficiency with Microsoft office/SharePoint packages. Some experience of asset management tools is an advantage
• Line management and team development skills
• GMP regulatory knowledge to support document authoring and review, inspections and audits, and Quality records management.
• Client-facing skills to collaborate with internal and external customers.
• Delegation and task management skills to deliver multiple projects and activities to required timelines.
• Understanding of the requirements and guidelines of regulatory authorities
• Excellent problem-solving skills.
• Open for occasional travel to other sites when appropriate