NPI/Tech Transfer Specialist, Technical Engineering

Job description

Job Description A fantastic opportunity has arisen for a NPI/Tech Transfer Specialist. 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 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 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 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: 08/20/2026*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.