Laboratory Systems IT Engineer

3 weeks ago

Newtown, Ireland Quanta Consultancy Services Ltd Full time
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, is 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

1. Ownership and administration of the IS aspects of Lab equipment – including analytical equipment platform architecture, system ownership, and lifecycle management.
2. 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.
3. Lead and support system improvements, development of detailed specification, and standard operating procedures.
4. Ensure reliable, consistent & compliant operation of Lab Equipment Instruments to meet the GMP and business requirements of the labs.
5. Lead technical root cause analysis, incident investigations, and troubleshooting issues related to the Quality and Laboratory information systems.
6. Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
7. Participate in Computer Software Validations and protocol/script writing.
8. Support new technology introductions by performing IS assessments and implementing IS system configuration changes.
9. Solving complex problems, project management, lifecycle management, and operational excellence.

Requirements

1. Experience with LIMS and Empower is desirable.
2. Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals; ICH and GMP guidelines desirable in relation to Lab IT requirements.
3. Experience with regulatory/customer audits is desirable.
4. 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.
5. Experience with Empower CDS, Sample Manager LIMS, Laboratory Analytical Equipment, and instruments will be an advantage.

1. Candidates must have a working knowledge of the GAMP software development lifecycle.

2. Experience with facility start-up projects (brown field or green field) is desirable.

3. Experience in Training of personnel.

4. Previous experience in a Quality Control/GMP environment is required.

6. Experience with Microsoft Word, Excel, PowerPoint, Visio, and Project is required.
7. Knowledge of analytical testing in support of biopharmaceutical manufacturing is preferred but not required.
8. Ability to master, with minimal support, new IS technologies and processes.
9. Strong knowledge of databases, reporting, and analytic systems.
10. Ability to ensure compliance with practices, policies, procedures, legal requirements and site objectives and goals.
11. University degree in related science/IT/quality discipline required.

If this role is of interest to you, please apply now

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