Engineering & Electronics
Instrument Validation Specialist
- The Analytical Development and Commercialisation (ADC) department is responsible for all analytical support to the site. This involves testing of raw materials, Excipients, Components, intermediates, Drug Substance and Drug product.
- The position reports to the Laboratory Systems Lead.
- 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
- Souring 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.
Education and Experience:
- Applications are invited from candidates who have a degree in Science (Chemistry, Physics or related Life Science) with 1-2 years’ relevant experience.
- Have knowledge of GMP standards
- Have knowledge Laboratory safety standards
- Must have good communication skills, both written and verbal.
- Strong documentation skills are required.
- 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)
Interested candidates should submit an updated CV.
Please click the link below to apply, call Holly on 0214297900 or alternatively send an up to date CV to Holly.Courtney@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***