Senior QC Validation & Equipment Lifecycle Lead

Life Science Recruitment; Leinster; On-site; EUR 55,000 - 75,000; Full time

Job summary

Life Science Recruitment is seeking a Technical Services Specialist for a leading healthcare organisation in Dublin. The role acts as System Owner/Process Owner for the Technical Services Team and is responsible for owning and delivering key quality, qualification and validation lifecycle documentation, while supporting resource planning.

Responsibilities include routine calibration/maintenance in a cGMP environment, writing validation protocols and reports, CMMS Maximo management, change

Qualifications

• Bachelor's degree in science or related field.
• 5+ years laboratory experience in a cGMP setting.
• Experience with analytical instrument validation and data integrity.

Responsibilities

• Plan and supervise calibration, requalification and maintenance of lab equipment per CMMS Maximo.
• Draft and review qualification protocols and summary reports for new equipment.
• Conduct audit trail reviews as part of validation lifecycle for computerised lab equipment.
• Coordinate equipment repairs with vendors, minimise downtime.
• Act as SME on instrument validation regulations and procedures.
• Own change controls and project components in Maximo.
• Support Data Integrity Assessments for lab systems.
• Peer-review validation documents and system guides.

Skills

Laboratory maintenance

Documentation & validation

Regulatory compliance

Project coordination

Education

Bachelor's degree in Science

Tools

CMMS Maximo

Change Control

Job description

Life Science Recruitment is seeking a Technical Services Specialist for a leading healthcare organisation in Dublin. The role acts as System Owner/Process Owner for the Technical Services Team and is responsible for owning and delivering key quality, qualification and validation lifecycle documentation, while supporting resource planning.

Responsibilities include routine calibration/maintenance in a cGMP environment, writing validation protocols and reports, CMMS Maximo management, change