MSD Compliance Engineer 

Ireland 

443225561

Job Description

Bring your energy, knowledge, and innovation to:

• 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:

To excel in this role, you will have:

• 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 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.

So, if you are ready to:

Current Contingent Workers apply

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