Laboratory Systems IT Engineer - Pharmaceuticals - 12-Month Contract
We are seeking a Laboratory Systems IT Engineer to join our client, a leading pharmaceutical organization, in Ireland.
Key Responsibilities:
* Ownership and administration of the IS aspects of Lab equipment, 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.
* Lead and support system improvements, development of detailed specification, and standard operating procedures.
* Ensure reliable, consistent & compliant operation of Lab Equipment Instruments 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 protocol/script 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.
Additional Skills:
* 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.
Salary:
$80,000 - $120,000 per year