Teva Lab Equipment Qualification Engineer 

Netherlands, North Holland, Haarlem 

522451303

As the Lab Equipment Specialist you will primarily focus on ensuring the efficient and compliant operation of sophisticated laboratory equipment used for analytical testing in the production of Cytotoxic drug products. This involves assessing, qualifying, validating, and implementing high-end laboratory equipment, managing related documentation, and ensuring adherence to regulatory standards. The role also focuses on continuous improvement, maintaining quality systems, coordinating with multiple departments and contractors, and acting as a key liaison between suppliers and the laboratory.

• Assess, qualify (including validation), and implement sophisticated high-end (computerized) laboratory equipment.
• Determine priorities within your project while tracking project execution across multiple departments.
• Oversee the timely completion of all validation documentation, including coordinating contractor activities.
• Support the regulatory defense of validation protocols and summary reports during audits and internal audits.
• Review quality system documents, including CAPA, change controls, investigations, and deviations.
• Develop and support continuous improvement initiatives for the validation of equipment, facilities, utilities, and control systems.
• Present project status to stakeholders and (senior) management.
• Write training instructions, calibration, maintenance, operational procedures, equipment specification files, and reports (URS, Risk assessments, IQ/OQ/PQ).
• Act as a Subject Matter Expert and actively participate during audits.
• Serve as the point of contact between suppliers and the laboratory.
• Manage contracts for maintenance and/or calibration.
• Manage computerized systems and applicable software.
• Develop Validation Master Plans, Validation Project Plans, and Project Schedules as needed.
  

• Bachelor or Master degree in the life sciences and have interest in IT environment
• Experience in the Pharmaceutical industry or an equivalent GMP environment for 4-5 years with at least 1 year experience on validation of laboratory equipment
• Organizational capabilities is part of your nature
• Team player with sound communication skills and pro-active approach.
• Experience with scientific analytical approaches
• Good knowledge of laboratory equipment with experience in calibration, qualification and validation
• Experience with deviations, changes and CAPA writing
• Good problem solving skills
• Support laboratory investigations as equipment SME
• Knowledge of Empower CDS (in combination with (U)HPLC and GC), particle analysis and basic analytical instruments is a pre
  

Ivo Huijskens - Senior Recruiter Benelux & Nordics

Group Leader QC Planning and Coordination

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