GMP Systems Engineer – E-Systems & Lab QA

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

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.