Lab IT CSV Engineer 1658

Simotechnology; Cork; On-site; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Educational support

Career progression

Competitive salary

Job summary

SimoTech is recruiting an engineer with 3+ years in Computer Systems Validation and Laboratory IT systems to support a state-of-the-art pharmaceutical facility in Cork. The role sits within the Computerised Instruments team, offering hybrid working arrangements and exposure to a GMP/GxP environment.

The ideal candidate will ensure data integrity, security, lifecycle management and regulatory compliance across multiple instrument systems in manufacturing operations.

Qualifications

• 3+ years’ experience validating laboratory computerized systems.
• Experience in GMP environment and data integrity.
• Knowledge of 21 CFR Part 11 and data integrity guidelines.
• Experience with IT applications change control.
• Strong interpersonal and communication skills across functions.

Responsibilities

• Manage the Lab System CSV deliverables from initiation to release, prioritising activity per project schedules.
• Generate validation documentation per site procedures and regulatory guidelines such as 21 CFR Part 11 and EU GMP Annex 11.
• Collaborate with 3rd parties to install computerized instrument solutions and integrate with on-site IT services.
• Initiate and implement Change Control activities in line with quality standards.
• Support EHS procedures and assist in incident investigations; participate in team meetings.

Skills

IT Applications

Validation

GxP compliance

Data integrity

Documentation

Regulatory knowledge

Cross-functional collaboration

Tools

MS Office

Software installation

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.

SimoTech has a new opportunity for an engineerwith 3+ years’ experience in Computer Systems Validation and Laboratory IT systemsto join our team. The successful candidate will work as part of our client’s ComputerisedInstruments team, supporting a variety of computerised instrument systemsacross laboratory and manufacturing operations at their state-of-the-artpharmaceutical manufacturing facility in Cork. The role has a hybrid workingmodel.

The ideal candidate will have a minimum of 3 years’experience in a similar role within a GMP / GxP environment, ensuringcomputerised instrument systems meet all data integrity, cyber security,quality, lifecycle management and regulatory 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