Lab IT CSV Engineer 1647

Simotechnology; Cork; On-site; EUR 50,000 - 70,000; Full time

Benefits offered by this job

Excellent salary

Career progression

Educational support

Autonomy in role

Job summary

A leading technology firm in County Cork is seeking an experienced engineer for Computer Systems Validation. The role requires a minimum of 3 years in a GMP environment, focusing on the support and validation of laboratory IT systems. Responsibilities include managing Lab System deliverables, generating documentation, and collaborating with third parties on installations. The position offers excellent benefits and a hybrid working model, providing autonomy and opportunities for skill development.

Qualifications

• Minimum 3 years' experience in Computer Systems Validation in a GMP environment.
• Experience in writing validation plans and system testing.
• Knowledge of 21 CFR Part 11 and data integrity guidelines.

Responsibilities

• Manage and coordinate Lab System CSV deliverables from initiation to release.
• Generate validation documentation following regulatory guidelines.
• Work closely with third parties to install computerised instrument solutions.

Skills

Validation of laboratory computer systems

GMP environment experience

Communication skills

MS Office proficiency

Job description

Whatis it like to work at SimoTech? With a strong collaborative teamworkculture based on respect, trust, and excellence, we play a criticalpartnering role to our clients’ life-changing supply of products topatients. In return, there is excellent salary, benefits, careerprogression, educational support andmuch more.

SimoTechhas a new opportunity for an engineer with 3+ years’ experience in ComputerSystems Validation and Laboratory IT systems to join our team. The successfulcandidate will work as part of our client’s Computerised Instruments team, supportinga variety of computerised instrument systems across laboratory andmanufacturing operations at their state-of-the-art pharmaceutical manufacturingfacility in Cork. The role has a hybrid working model.

Theideal candidate will have a minimum of 3 years’ experience in a similar rolewithin a GMP / GxP environment, ensuring computerised instrument systems meetall data integrity, cyber security, quality, lifecycle management andregulatory requirements.

Key Responsibilities

• Manageand coordinate the Lab System CSV deliverables for new and existing projectsfrom initiation to release, prioritising support activities in line withproject schedules.
• Generatevalidation documentation in accordance with site procedures and regulatoryguidelines, including but not limited to, 21 CFR Part 11, EU GMP Annex 11, and dataintegrity guidelines.
• Work closely with 3 rd parties to installcomputerised instrument solutions, ensuring correct configuration to successfullyintegrate with existing onsite IT services and infrastructure.
• Initiate and implement Change Control activities inaccordance with quality standards and practices.
• Followall relevant EHS procedures and assist in incident investigations as required.
• Recognisethe importance of the quality control function in pharmaceuticalproduction.
• Actively participate and contribute to teammeetings.

Requirements

Qualifications &Experience

• 3+years’ experience supporting IT Applications including validating laboratory computerisedsystems, writing validation plans, requirements gathering, designdocumentation, system configuration, system testing and troubleshooting.
• Experience implementingchanges for IT applications in a GMP environment.
• Knowledge of 21 CFR Part 11and data integrity guidelines.
• Experience with MS Office andsoftware installation knowledge.
• Strong interpersonal andcommunication skills are required, with proven ability to communicate and buildrelationships cross-functionally.

What SimoTech CanOffer

• Role provides ahigh degree of autonomy to allow the successfulcandidate to reach their fullpotential.
• Develop newskills and enhance technical ability by working withinnovative technologies in a multi- disciplinedenvironment.
• Opportunity towork with large corporate clients