E Systems Engineer

Cognizant Life Sciences Manufacturing; Cork; On-site; EUR 65,000 - 90,000; Full time

Job summary

Cognizant Life Sciences Manufacturing is seeking a Laboratory E-Systems Specialist to provide operational and technical support for analytical testing systems. You will act as system administrator for Empower, Smartlab, LIMS and NuGenesis and liaise with IT for upgrades and validation.

The role requires ensuring GMP compliance, supporting cGMP training, and contributing to Lab Quality System development. Strong QA focus and regulatory understanding are essential.

Qualifications

• BSc, MSc or PhD in Chemistry, Biology, Microbiology, Engineering or related discipline.
• Experience with electronic systems in analytical labs (CSV/validation a plus).
• Strong knowledge of cGMPs, regulatory commitments and QA processes.

Responsibilities

• Act as system administrator for laboratory E-Systems (Empower, Smartlab, LIMS, NuGenesis).
• Coordinate with IT on system upgrades and validation.
• Serve as primary contact to global system representatives.
• Ensure all materials and products are analyzed per quality standards.
• Investigate non-conformances and document root-cause analyses.
• Review and approve analytical procedures, investigations and deviations.
• Own change controls related to E-Systems.
• Provide training on updates to cGMPs affecting testing.
• Keep current with cGMPs and regulatory expectations.
• Support writing of CSV documents and lab quality systems.

Skills

System administration

cGMP knowledge

QA support

Analytical testing

Education

BSc/MSc/PhD in Chemistry or related

Tools

Empower

Smartlab

LIMS

NuGenesis ELN

Job description

Responsible for operational and technical support of the electronic systems used to perform analytical testing, recording and reporting analytical test results. The electronic systems include systems such as Water’s Empower chromatography data system (CDS), Biovia’s Smartlab system, NuGenesis Electronic Laboratory Notebook (ELN), Thermo Scientific Darwin Laboratory Information Management System (LIMS) and Lonza’s MODA.

About the Role

Responsible for ensuring that materials and products are analysed in accordance with current Good Manufacturing Practices, conform with regulatory commitments and meet all required quality standards both during and on completion of analysis. Ensures that site and corporate quality policies related to the analysis of GMP materials are followed.

Responsibilities

• Acts as system administrator for E-Systems utilized in the laboratory (e.g. Empower, Smartlab, LIMS, NuGenesis).
• Acts as primary contact with IT regarding system upgrades and validation of electronic systems used across the laboratory.
• Acts as primary contact to global system representatives.
• Assure that all raw materials, in-process samples, intermediates or final products are appropriately analysed and authorised.
• In the event of non-conformance to acceptable quality and/or safety standards, ensure appropriate investigations are undertaken and documented, using Root Cause Analysis techniques where appropriate.
• Ensure all associated countermeasures are complete.
• Review and approve analytical procedures, investigations, and deviations.
• Own and review change controls pertaining to E-Systems.
• Provide guidance and training to other team members on updates to the cGMPs, which pertain to testing.
• Keep current with cGMPs.
• Investigate and report on customer complaints and recommend countermeasures.
• Support the writing of E-Systems Computer Systems Validation (CSV) documents.
• Provide technical support to Lab analysts and other technical staff.
• Support the qualification of E-Systems connected analytical equipment in accordance with local procedure.
• Assist in ensuring that lab equipment is satisfactorily qualified and maintained.
• Assist in developing, implementing and maintaining the Lab Quality System.
• Assist in ensuring that analytical operations are undertaken safely.
• Assist in developing Site Quality Systems.
• Support and participate in self inspection or other audits with particular reference to the analytical aspects of cGMPs as defined by the Health Authorities, Food and Drug Administration, etc.
• Assist in education of teams in the role and capability of the Quality Control Laboratory Team.
• Provide input to operation of associated team.
• Participate where required in the development and implementation of business plans.
• Support the timely closure of Non-Terminal Data in QCL E-Systems.

Qualifications

May hold BSc, MSc, or PhD in Chemistry, Biology, Microbiology, Engineering or related discipline.