Laboratory Systems IT Engineer - Pharmaceuticals - 12-Month Contract
We are seeking a skilled Laboratory Systems IT Engineer to join our client's team in Ireland. The successful candidate will contribute to the development of core projects and help maintain the integrity of laboratory systems.
Essential Duties and Responsibilities:
* Ownership and administration of lab equipment IS aspects, including analytical equipment platform architecture, system ownership, and lifecycle management.
* Effective communication and project management interaction with internal and external clients, such as Quality Assurance, Regulatory Affairs, and QC analytical personnel.
* Leading and supporting system improvements, developing detailed specifications, and standard operating procedures.
* Ensuring reliable, consistent, and compliant operation of lab equipment instruments to meet GMP and business requirements.
* Leading technical root cause analysis, incident investigations, and troubleshooting issues related to quality and laboratory information systems.
* Experience in change control, non-conformance, corrective, and preventative actions, and validation practices.
* Participating in computer software validations and protocol/script writing.
* Supporting 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 for 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 similar laboratory environments.
* Experience with Empower CDS, Sample Manager LIMS, laboratory analytical equipment, and instruments will be an advantage.
- A working knowledge of the GAMP software development lifecycle is required.
- Experience with facility start-up projects (brown field or green field) is desirable.
- Experience in training personnel is beneficial.
- Previous experience in a quality control/GMP environment is essential.
6. Proficiency in 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 new IS technologies and processes with minimal support.
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 a related science/IT/quality discipline is required.