- Manage routine maintenance and calibrations of analytical instrumentation in laboratories and manufacturing suites on site.
- Supervise external vendors for maintenance and calibrations in laboratories and manufacturing areas.
- Review and approve data/documentation from external vendors.
- Collaborate with area owners, IT, and site services for timely calibrations following data integrity, regulatory, and industry standards.
- Enter routine data in the local calibration maintenance software.
- Participate in deviations, CAPA's, and change controls related to instrument maintenance aligned with team priorities.
- Provide support for maintaining permanent inspection readiness for regulatory and internal audits.
- Level 7 or level 8 in Engineering, science, or related field or relevant work experience.
- 3-5 years of relevant experience.
- Experience with automation, instrumentation design, and SLC documents.
- Preferably experienced in the Biotech/Pharmaceutical sector.
- Worked in a GMP regulated environment.
- Understanding of change management for validated systems and software.
- Experience with regulatory audits and flexibility to adapt to business changes.
- Excellent verbal and written communication skills.
- Ability to manage multiple tasks effectively and willing to travel.
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Instrumentation Engineer/Metrology Specialist - County Meath, Ireland - Orion Group
Description
Orion Group Sciences is currently hiring an Instrumentation Engineer/Metrology Specialist for a Multinational Biopharmaceutical client in Dunboyne on an 11-month contract.
Job Purpose:
Responsibilities:
Educational and Experience Requirements:
Our commitment to diversity and inclusion
We aim to recruit personnel who reflect the diversity of our client base and values. We embrace diverse experiences, nationalities, genders, cultures, backgrounds, races, ethnicities, sexual orientations, identities, disabilities, age differences, job classifications, and religions. In our inclusive workplace, all individuals, whether staff or contract, are entitled to fair, respectful, and equitable treatment.
