Instrument Specialist

Summary:
An amazing opportunity has arisen for an Instrument Validation Specialist with a pharmaceutical company in Tipperary. The position offers the opportunity to work with a team of professionals in a modern analytical laboratory using the most up to date technology and quality assurance procedures. The laboratory operates under Lean principles and employees the use of a wide variety of analytical techniques

Responsibilities:

• Sourcing and procurement of Analytical Laboratory instrumentation.
• Responsible for the execution of the yearly Laboratory Capital Equipment Installation plan.
• Responsible for the generation and completion of SDLC Validation documentation for new equipment and COTS based computerised system introduced to the site.
• Maintaining Analytical Laboratory instrumentation in validated state to support testing activities in accordance with site schedules and company policies, procedures and guidelines.
• Support the introduction of new technology and instrumentation to the site with a focus on Data Integrity principles.
• Responsible for the decommissioning of all equipment as appropriate.
• Be part of a dynamic team responsible for Data Integrity requirements for all computerised and non-computerised systems across all the laboratories.
• Aid in the resolution of issues that may arise during laboratory instrument qualification and use.
• Participate in assigned improvement projects.

Qualifications & Experience:

• Degree in Science (Chemistry, Physics or related Life Science) and/or relevant experience.
• Knowledge of GMP standards.
• Have knowledge Laboratory safety standards.
• Must have good communication skills, both written and verbal.
• Strong documentation skills are required.
• Must be motivated, focused and technically strong.
• To perform instrument maintenance and troubleshooting.
• To maintain accurate records in compliance with GMP expectations.
• To understand and internalise procedures relevant to GMP operations.
• Technical lab skills (precision, etc).
• Communication – written, oral.
• Team and interpersonal skills.