NPI/Tech Transfer Specialist, Technical Engineering

Posted 7 hours 10 minutes ago by MSD Malaysia

Permanent
Full Time
Other
Leinster, Carlow, Ireland
Job Description
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 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.


What skills you will need:

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


Minimum of three years within the pharmaceutical industry


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 Equipment and process validation Sterile filling processes and equipment 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


Required Skills:

Change Management, Equipment Qualification, GMP Compliance, Ishikawa Diagrams, Project Manufacturing, Sterile Processing, Technology Transfer


Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s):


Job Posting End Date: 08/20/2026


Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.