Job Description

A fantastic opportunity has arisen for a Spclst, Engineering.

This role is primarily within the NPI Technical Engineering team, supporting the New Product Introductions.

What you will do:

Bring energy, knowledge, innovation and leadership to carry out the following:

• Supporting New Product Introductions/Technical Transfers
• Responsible for providing process, technical, and validation support operations including ongoing support of manufacturing processes and support for new product introduction.

• Accountable for analytical/engineering studies associated with the development of new components, products, processes systems and facilities.

• Co-ordination, design and execution of equipment qualification and validation as required.

• Serve as technical and/or validation support as required for manufacturing and new product introduction.

• Design/Author/Review/Approve/Execute process development studies in support of new product introduction and ongoing manufacturing support.

• Provide technical input into quality notification by authoring/reviewing/approving investigations. Execution of equipment commissioning and qualification programs

• Execution of equipment/qualification validation programs; including re-qualification and re validation Design/Author/Review/Approve/Execute qualification/validation 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 site at global technical forums.

• Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups. Drive compliance of our company's Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made. Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.

• Work collaboratively to drive a safe and compliant culture on site. May be required to perform other duties as assigned.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Typical Minimum Education: Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline

• Relevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably in a 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
• Understand the specific responsibilities of all site departments as they relate to one's own department, understanding the business processes ones department supports
• Customer service
• Project management skills
• Risk management skills
• Strong influencing skills
• Flexible approach
• Effective time management and multi-tasking skills
• Excellent attention to detail
• Trouble shooting skills
• Data Analysis
• Goal/results orientated
• Demonstrable analytical and systematic problem solving skills
• Strong change management skills
• Effective conflict resolution skills
• Negotiation skills
• Project management skills
• Risk management skills

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.

Required Skills:

Adaptability, Adaptability, Business, Business Processes, Change Control Management, Customer Service, Customer-Support, Data Analysis, Documentations, Equipment Troubleshooting, GMP Compliance, Good Manufacturing Practices (GMP), Ishikawa Diagrams, Lean Manufacturing, Personal Initiative, Process Optimization, Professional Integrity, Project Management, Public Policy Writing, Regulatory Requirements, Risk Assessments, Risk Management, Root Cause Analysis (RCA), Technical Writing, Technology Transfer {+ 1 more}

Preferred Skills:

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. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

03/25/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.