Job Description
A fantastic and exciting opportunity has arisen for a Compliance Engineer at our Dunboyne Biologics. This position will act as system owner /subject matter expert for Engineering standards and guidelines within the Quality Management System.
Dunboyne serves as a magnetic force that attracts, recognizes, and integrates people of diverse backgrounds and perspectives. Employees will feel not only that they belong in Dunboyne, but that the facility belongs to and is shaped by them.
What you will do: Manage and support compliance of Engineering processes with the site Quality and EHS requirements – Change Control, Investigations, CAPA, Training Plans, etc.Actively drive culture of compliance within Engineering.Build team capability in all aspects of compliance. Coach, mentor and influence team members to excellence around compliance mindset and execution of work practices.Liaise closely with the Quality and EHS functions on compliance matters within Engineering.Identify and escalate compliance issues.Coordinate and execute gap assessments of current processes against corporate quality standards and industry best practices; identify remediation and ongoing improvement (compliance and efficiency) actions and drive to completion.Maintain compliance metrics within Engineering.Support ongoing assessment and improvement of engineering and facility systems against cGMP requirements, including Quality Management System standards and guidelines.Manage compliance inspection readiness, including internal auditing.Continually monitor industry policies, procedures, standards and programs; recommend improvements where necessary.Liaise with corporate and Ireland-site colleagues on the application of engineering quality standards; take part in cross-site teams to support standardised application across sites.Act as engineering representative on relevant cross functional site projects.Provide coaching and relevant training and support to colleagues.Lead and support relevant site investigations, identifying root cause and measures to prevent recurrence.What skills you will need: 3rd level qualification in a Quality, Engineering, technical discipline or equivalent.At least 8 years relevant experience in biotechnology, pharmaceutical industry or equivalent.In-depth knowledge of cGMP regulatory requirements for management of engineering systems and processes.Experience in executing risk assessments.Experience in auditing.A good understanding of manufacturing processes, equipment, utilities and maintenance practices.Experience in investigation and problem solving using structured problem-solving techniques such as six-sigma, lean, root cause analysis.Proven experience in implementing change and project management.The ability to think logically and work proactively under pressure.The ability to work as part of a team and on own initiative in a constructive manner.Excellent verbal and written communication skills.As a company, we are committed to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.
So, if you are ready to: Invent solutions to meet unmet healthcare needs, impact the future by driving one of the world's leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.
Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.
Employee Status: Regular
Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid
Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 01/7/2025
*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID: R325154
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