Engineering Compliance Specialist An Engineering Compliance Specialist is required to join a leading biotechnology manufacturing company based in Limerick. This position offers an impressive and unique opportunity for interested candidates. This position requires people who want to be challenged, have a passion for success, and a constant drive to exceed expectations.This role will be responsible for responsible for ensuring cGMP compliance for the Tech Ops Engineering & Automation Department. This is a perfect opportunity to join a select team that has already established itself as a frontrunner leading the way in the Pharmaceutical/Biotech industry. Key Responsibilities Facilitates reviews and revisions of Department related SOP's, life cycle documents, plans and policies for each group within the Department.Acts as a liaison between Engineering & Automation and onsite quality and regulatory groups to define and address compliance related items.Identifies opportunities for continuous improvement of compliance and leads improvement initiatives.Provides support, information, and assistance to individuals, groups and management with the initiation, review, submission, and follow-up of documents such as Change Controls, EOE's, NOE's, DNF's, risk assessments, impact statements and corrective/prevention action plans.Participates in investigations and root cause analysis for any issues of non-compliance.Provides periodic reviews of department documentation and records such as Periodic Evaluation Reports (PER), logbooks, preventative maintenance records/work orders, etc. to assess for compliance with established quality standards, policies and procedures.Provides tracking and trending for maintenance of related compliance activities i.e. quality instances and PERs.Participates in and obtains results of department quality and regulatory audits.Specifies and coordinates training, OJT and SOP, for Automation, Engineering and contracted personnel.Maintains knowledge of current good manufacturing practices (cGMPs). Education/ExperienceRequires BA/BS (engineering or scientific related field preferred) and 3+ years of related experience working in a cGMP environment or in the operation of an industrial facility. May substitute relevant experience in lieu of education.Ability to work on own initiative, without direct supervision from management.Team player with an ability to work well across various departments on site as well as business partners.Excellent written, presentation, communication and investigation skills.Deadline focused individual. Interested? Contact Jack on 01-6455250, or Click Apply below!