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 ATMPs 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.

Location: Onsite Laboratory & Office Environment

Schedule: Full-time includes oncall responsibilities

We are seeking an experienced GMP Equipment Manager in Biopharm CMC to oversee the performance and supervision of our Equipment Management team in Mechelen Belgium.

This team plays a critical role in ensuring the maintenance calibration and compliance of laboratory equipment in alignment with GMP regulations and departmental policies.

In this leadership position you will plan prioritize and manage all equipmentrelated activities to meet operational timelines while minimizing business impact from equipment issues through proactive control and risk management.

You will serve as the sites subject matter expert (SME) for equipment management representing the business during client and regulatory audits and acting as the primary escalation point for complex equipment challenges.

You will be instrumental in the set-up of the new laboratory in Mechelen and will be required to build and develop your team.

This is a fully onsite role involving both laboratory and office work. Physical requirements include but are not limited to:

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

Job Responsibilities:

• Lead mentor and develop the Mechelen site Equipment Management team to deliver highquality 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 crossfunctional 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 Qualifications:

• 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

Preferred Qualifications:

• 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

Additional Job Standards:

• 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

Labcorp is proud to be an Equal Opportunity Employer:

Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race religion color national origin sex (including pregnancy childbirth or related medical conditions) family or parental status marital civil union or domestic partnership status sexual orientation gender identity gender expression personal appearance age veteran status disability genetic information or any other legally protected characteristic. Additionally all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.

We encourage all to apply

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