Cpl in partnership with SK biotek are seeking to recruit an experienced Laboratory Analyst responsible for Equipment and Software on a 12 month contract to join the team in the Swords campus.
Job title:
Laboratory Analyst, Equipment and Software
Job description:
This resource will support the implementation process for new laboratory equipment installations within the analytical teams of QC and Analytical R&D (AR&D), utilising support from other departments such as QA, IT and analytical as required, so needs to have specific knowledge of the end-to-end equipment installation and qualification process for analytical instrumentation in a cGMP environment.
Responsibilities:
The key responsibilities of the Laboratory Analyst, Equipment and Software – shall include but shall not be limited to:
• Support the implementation and qualification of analytical instruments, and their routine/periodic maintenance.
• Develop standard operating procedures, specifications, and local analytical methods.
• Ensure GMP Compliance of laboratory operations and documentation, including testing, write ups, review and approval of protocols, reports and change controls.
• Managing equipment supplier relations, for new equipment and software to be used in the Laboratory.
• Support equipment installation related deviation investigations and record any errors encountered, as per procedures and training.
• Establish and maintain internal and external communication with stakeholders from adjacent departments, supporting functions and external vendors.
• Assist in the training of other personnel and as their level of skill develops, may be responsible for the full training of other Laboratory personnel.
• Foster and support a culture of growth, enablement and high performance.
Basic Requirements:
• Minimum BSc (Hons) in Analytical Sciences (Chemistry, Biochemistry, Microbiology) with a minimum of 3 years pharmaceutical experience.
• Demonstrated ability of successful equipment installation and qualification and associated tasks.
• Experience of HPLC/GC testing and set-up for different analytical processes.
• Experience in a small molecule contract development and manufacturing or pharmaceutical environment.
• Comprehensive knowledge of quality control operations.
• Understanding of multiple instrument platforms, vendors and associated software applications.
Additional Skills/Preferences:
• Demonstrated leadership competencies by leading a team or department close to QC, QA and/or IT operations.
• Proven to be an excellent communicator and motivator to drive interdepartmental initiatives.
• Proven ability to implement changes in operational, technology and business process workflows in a pharmaceutical environment.
• Demonstrated expertise of Data Integrity/Orchestration and its application in (Pre-) Digital Laboratory Operations.