CSV Engineer

Cognizant Life Sciences Manufacturing; Cork; On-site; EUR 60,000 - 90,000; Full time

Job summary

Cognizant Life Sciences Manufacturing is seeking a Lab IT Application specialist to lead the lifecycle of laboratory IT applications at the site. You will coordinate BAU support, transitions, upgrades, and vendor interactions for instrument software.

Ideal candidates will have a CS degree and 2+ years in Lab IT with LIMS/CDS, plus experience with CSV validation and GMP/GxP standards.

Qualifications

• Degree in Computer Science or relevant equivalent.
• 2+ years IT experience with Laboratory Systems (LIMS / CDS).
• Experience delivering CSV validation and GMP/GxP aligned solutions.

Responsibilities

• Lead deployment of new lab IT applications and upgrades.
• Coordinate with vendors for installation and config of instrument software.
• Deliver changes to systems per prioritized business needs.
• Ensure security, availability, and risk management for apps.
• Assist CSV with system validation and changes.
• Support GMP, FDA, HPRA audits.

Skills

Degree in Computer Science

Lab IT lifecycle

LIMS/CDS experience

GxP/compliance

Oracle/SQL

Empower/Chromeleon/Nugenesis

Cross-training

Team player

Strong communication

Education

Degree in Computer Science

Tools

LIMS

CDS

Oracle

SQL

Job description

Cognizant is a world leader in delivering digital transformation solutions to Life Sciences. Through our knowledge and expertise in Automation, MES & Digital, we deliver stable manufacturing systems that are optimised to improve operational efficiencies, whilst maintaining compliance. Our specialist engineering teams have the aptitude to deliver and support Pharma 4.0 architectures and solutions covering all IT, OT and IoT applications, infrastructures and services.

About the role:

The Lab IT Application specialist will be the Lead company contact for all Laboratory IT applications at the Site. They will be responsible for supporting the lifecycle of applications including IT transition projects and Business as Usual (BAU) support. Projects will include new systems, activity driven by transition to SGS and upgrades to existing application assets (e.g. W10 upgrades). In BAU, the specialist will coordinate and resolve issues and support improvements to these applications on behalf of the Business Owners.

Responsibilities & Tasks

• Work with the Business Owners on implementing new applications, upgrades to existing applications or transitioning systems from one company to another.
• Interact with vendors to ensure successful installation and correct configuration of instrument software.
• Work with the relevant Business Owners to deliver on an agreed prioritized list of changes to systems.
• Implement new releases and set up standards for operational management including security, capacity, high availability and identifying associated risks.
• Investigate and troubleshoot relevant lab IT applications and instrument problems and implement changes and/or improvements, with external Vendor support where necessary.
• For the Chromatography Data System and other applications if required, configure, and manage Development, Validation and Production environments.
• Assist the CSV Engineer with the validation of /changes to the system in line with internal CSV procedures.
• Configure, implement, and optimize Business Applications.
• Coordinates, tests, and administers application security.
• Complies with GMP standards, global and local SOPs and provides support during regulatory audits such as FDA and HPRA.
• Liaise with Infrastructure /IT Manager regarding laboratory support needs.

Skills & Experience

• Degree in Computer Science or relevant equivalent
• Experience supporting lab IT lifecycle changes such as application upgrades or new deployments of software and instruments, supporting installation and relevant CSV needs from IT app perspective.
• 2 yrs + experience of working as an IT specialist with Laboratory Systems such as LIMS or Chromatographic Data Systems
• Excellent knowledge of Laboratory processes in a HPRA/FDA regulated pharmaceutical environment and experienced in providing solutions aligned with GMP/ GxP standards,
• Strong hands‑on technical IT skills, with an operational background and working experience with business applications and infrastructure technologies.
• Desirable to have strong understanding of database systems such as Oracle and/ or SQL.
• Preferably has Developer experience in LIMS or CDS Applications (Empower, Chromeleon or Nugenesis)
• Demonstrated willingness to cross train and to learn additional technical expertise.
• Team player
• Strong oral and written communication skills with proven ability to communicate and build relationships cross‑functionally with other teams and Lab users