Laboratory Systems IT Engineer - Pharmaceuticals - 12-Month Contract
Are you local to Ireland and looking for your next contract assignment? Our client, a leading pharmaceutical organisation, are recruiting for a Laboratory Systems IT Engineer to join their newly assembled team and help contribute towards the development of their next core projects.
Essential Duties and Responsibilities
- Ownership and administration of the IS aspects of Lab equipment – including analytical equipment platform architecture, system ownership and lifecycle management.
- Provide effective communication and play a leading role in project management interaction with internal and external clients such as Quality Assurance, Regulatory Affairs, and QC analytical personnel.
- Lead and support system improvements, development of detailed specification and standard operating procedures.
- Ensure reliable, consistent & compliant operation of Lab EquipmentInstruments to meet the GMP and business requirements of the labs.
- Lead technical root cause analysis, incident investigations and troubleshooting issues related to the Quality and Laboratory information systems.
- Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
- Participate in Computer Software Validations and protocolscript writing.
- Support new technology introductions by performing IS assessments and implementing IS system configuration changes.
- Solving complex problems, project management, lifecycle management and operational excellence.
Requirements
- Experience with LIMS and Empower is desirable.
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals; ICH and GMP guidelines desirable in relation to Lab IT requirements.
- Experience with regulatory/customer audits is desirable.
- At least 3 years’ experience supporting Quality and/or Laboratory information systems in the biotechnology or pharmaceutical industries or has worked in similar Laboratory environments and has gained expertise in the use of Laboratory information systems.
- Experience with Empower CDS, Sample Manager LIMS, Laboratory Analytical Equipment and instruments will be an advantage.
- Candidates must have a working knowledge of the GAMP software development lifecycle.
- Experience with facility start-up projects (brown field or green field) is desirable.
- Experience in Training of personnel.
- Previous experience in a Quality Control/GMP environment is required.
- Experience with Microsoft Word, Excel, Powerpoint, Visio, and Project is required.
- Knowledge of analytical testing in support of biopharmaceutical manufacturing is preferred but not required.
- Ability to master, with minimal support, new IS technologies and processes
- Strong knowledge of databases, reporting and analytic systems
- Ability to ensure compliance with practices, policies, procedures, legal requirements and site objectives and goals
- University degree in related science/IT/quality discipline required.
If this role is of interest to you, please apply now!
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