C&Q Lead Engineer Job - Ireland
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MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Responsible for leading the commissioning and qualification support for any new capital introduction. Co-ordination, design and execution of equipment qualification. and validation as required.
• Design/Author/Review/Approve/Execute commissioning and qualification in support of new capital introduction and ongoing manufacturing support.
• Provide technical input into quality notification by authoring/reviewing/approving investigations.
• Execution of equipment/qualification validation programs; including re-qualification and re-validation
• Design/Author/Review/Approve/Execute commissioning and qualification documentation and studies in line with the standard approval process
• Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis
• Support continuous improvement through Lean Six Sigma methodologies.
• Leading and active participation in projects, system failure investigations and investigation reports,
• Execution/development of change controls
• Contribution to Kaizen events as appropriate.
• Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.;
• Implement subsequent corrective action through the change management system.
• Serve as technical engineering representative for internal technical group discussions and represent technical Operations Carlow at global technical forums.
• Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
• May be required to perform other duties as assigned.
• Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline
• Would typically have prior related work experience; ideally in manufacturing, preferably GMP Setting
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
• Report, standards, policy writing skills required
• Equipment and process validation
• Sterile filling processes and equipment
• Proficiency in Microsoft Office and job related computer applications required
• Lean Six Sigma Methodology experience desired
• Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner
• Trouble shooting skills
• Data Analysis
• Goal/results orientated
• Negotiation skills
• Business acumen
• Strategy development
• Project management skills
• Risk management skills
• Progressive people management skills
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
Job: Manufacturing Engineering Job Title:C&Q Lead Engineer
Primary Location: EMEA-Ireland-Leinster-Carlow
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
External Job Board Posting: Ireland - IrishJobs.ie
Company Trade Name:MSD
Job Segment: Engineering Manager, Manufacturing Engineer, Engineer, Lean Six Sigma, Risk Management, Engineering, Management, Finance