Capital Specialist - Laboratory Instrumentation

Aphex Group; Munster; Vor Ort; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

Aphex Group seeks a Capital Specialist to manage day-to-day installation and decommissioning of laboratory instrumentation across Client/CDS in our Ireland operations. You will ensure instruments are installed and decommissioned in line with cGMP standards and MSD policies, with proper validation and documentation.

Responsibilities include coordinating with vendors, maintaining asset records, and driving quality and safety compliance while scheduling PM/PV activities and supporting continuous

Qualifikationen

• BSc in analytical chemistry, pharmaceutical science or related discipline required.
• Experience installing and decommissioning laboratory instrumentation in a regulated environment.
• Strong understanding of cGMP and safety/environmental requirements.
• Familiarity with validation concepts and documentation.

Aufgaben

• Install and decommission laboratory instrumentation for Client/CDS, coordinating with external support as needed to meet targets.
• Ensure cGMP compliance and act as auditee for this area; uphold safety and environmental standards.
• Validate instrumentation per MSD SDLC, review validations, and decommission instruments when appropriate.
• Ensure instruments are released in a validated state and tracked in the site asset management system for PM/PV scheduling.
• Troubleshoot installation issues, coordinate with vendor service engineers, and escalate investigations as required.
• Order and install new laboratory equipment with documentation aligned to MSD SDLC.

Kenntnisse

Instrumentation installation

cGMP compliance

Troubleshooting

Project management

Documentation

Communication skills

Teamwork

Ausbildung

BSc in analytical chemistry or related discipline

Tools

Asset management system

Jobbeschreibung

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 Client. The Capital Specialist also has responsibilities for management of Analytical equipment installation and decommissions in the CDS department.

Responsibilities

• The Capital Specialist has overall responsibility for installing and decommission Laboratory Instrumentation in Client/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 MSD 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 MSD 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.
• Company procedures, policies and guidelines
• Plant documentation
• Laboratory testing and documentation
• Validation principles and guidelines
• Computer skills
• System Development Life Cycle
• Project Management.
• Communication skills both written and oral
• Team and interpersonal skills
• Technical report writing
• Time Management
• Meetings Management
• Analytical Problem-solving skills
• Planning and Scheduling

Requirements:

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