Clean Utilities Compliance Engineer
A global innovator and leading bio pharmaceutical company that has been inventing new ground breaking treatments for numerous life threatening diseases for more than a century. Through this organisations prescription medicines, vaccines, biologic therapies, and animal health products, they work with customers and operate in more than 140 countries to deliver innovative health solutions. Recently a requirement has arisen to recruit a Clean Utilities Compliance Engineer to be based at the organisations Biologics manufacturing plant in Cork. Seeking an increase of over 100 employees in the next 12 months, you will be part of an exciting growth journey for a well-established site. The Role: Reporting into the Compliance Engineering Manager. The purpose of this role is to be a clean utilities SME as to assist with any queries in relation to design standards, engineering guides or other technical/compliance documentation in relation to clean utilities. This role will play a key part to ensuring compliance of the site clean utilities. Other activities within the role: Be responsible for adherence to site and corporate QMS for clean Utility Systems. Be the site SME for audits on clean utility systems. Point of contact for Quality Alerts and Bulletins for Utility Systems. Review and prepare formal responses. Ensure capital project delivery is adherent to QMS for clean utilities and designed in accordance with relevant engineering standards. This position will identify and implement best practices during capital project execution. Review and approve Utility & HVAC modifications, change requests, and SOP' The primary focus of the position is on GMP/clean utilities and operations (WFI, Purified Water, Clean Steam, Reverse Osmosis, Process Gasses, and HVAC systems. The Person: At least 5 years' experience in the Pharmaceutical industry or a similar operating environment. Degree or 3rd Level Qualification (Engineering), Masters preferred. Desirable to have qualification in Reliability Engineering and/or Project Management. Strong Compliance mind-set, demonstrated capability of understanding EHS & GMP compliance requirements, demonstrated capability within the Audit environment (specifically EHS & GMP. The Reward. This an organisation with excellent career progression and those who demonstrate excellence in the delivery of their role can be fast tracked. There is an excellent package on offer including Full Family Health care, Bonus, Defined Benefit Contribution with up to 33 days annual leave. Contact Chris Dennehy at HRM on 353 21 4511195 for further details on this role in confidence or apply online. This job originally appeared on RecruitIreland.com.
102 days ago