Lab Instrumentation Specialist

PE Global; Tipperary; Sur place; EUR 70 000 - 100 000; Plein temps

Résumé du poste

PE Global is seeking a Capital Specialist to manage day-to-day installation and decommissioning of laboratory instruments in ADC/CDS, ensuring minimal downtime and strict adherence to validation and compliance standards.

The role requires coordinating with vendors, maintaining asset management records, and leading documentation aligned with SDLC, with focus on safety and regulatory compliance. Ireland-based position in a regulated laboratory environment.

Qualifications

• BSc in analytical chemistry or related discipline.
• Experience with laboratory instrumentation and validation
• Knowledge of cGMP and regulatory requirements

Responsabilités

• Install and decommission laboratory instrumentation in ADC/CDS.
• Ensure compliance with cGMP and safety/environmental requirements.
• Validate instruments and coordinate with service engineers.
• Maintain instruments on PM/PV schedules and document activities.
• Troubleshoot installation issues and manage documentation throughout SDLC.

Connaissances

cGMP compliance

Analytical instrumentation

Project management

Documentation

Time management

Formation

BSc in Analytical Chemistry

Outils

Asset Management System

Validation Policies

Description du poste

Job Purpose: The role of the Capital Specialist is to ensure the day-to-day installation and decommission of all laboratory instruments, minimizing any downtime in the Laboratory. The role covers Drug Substance and Drug Product instrumentation in clinical and commercial areas for ADC. The Capital Specialist also has responsibilities for management of Analytical equipment installation and decommissions in the CDS department.

Principal Accountabilities:

• The Capital Specialist has overall responsibility for installing and decommission Laboratory Instrumentation in ADC/CDS. The Capital Specialist will complete installation and decommission activities and use external support as required to meet customer targets.
• The Capital Specialist is responsible for ensuring all Capital installs and decommissioning comply with cGMP, including acting as auditee for this area. The Capital Specialist assures compliance with all safety and environmental requirements. Compliance with other regulated areas such as trade compliance, human resources and spending are also responsibilities of the role for this scope of work.
• Installs all instrumentation in accordance with laboratory validation policies, procedures, and guidelines. Reviews and approves validation activities for instrumentation as required. Responsible for the decommissioning of instruments as appropriate.
• Ensures that all instruments are released in a validated state and setup on a site equipment asset management system so they can be maintained on a PM/PV schedule.
• Responsible for troubleshooting issues with during installation, ensuring that investigations are raised, investigated, and closed out as required and for coordinating with vendor service engineers to come on site.
• Ordering and installing new laboratory equipment, ensuring associated documentation is in accordance with SDLC (System Development Life Cycle).

Special Features

• The incumbent operates as part of a team and is self-directed team in carrying out day-to-day activities.
• On assignment, the incumbent participates in departmental initiatives on improved compliance and quality systems.

Core Competencies

Technical:

• MMD procedures, policies and guidelines
• Plant documentation
• Laboratory testing and documentation
• Validation principles and guidelines
• Computer skills
• System Development Life Cycle

Business:

• Project Management.

Leadership:

• Communication skills both written and oral
• Team and interpersonal skills
• Technical report writing
• Time Management
• Meetings Management
• Analytical Problem-solving skills
• Planning and Scheduling

Educational Requirements:

• BSc. (or equivalent experience base) in analytical chemistry, pharmaceutical science or a related discipline.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***