New Product Introduction, Technical Engineering Internship

Job Description Intern - NPI/Tech Transfer Team We aspire to be the premier research-intensive biopharmaceutical company. Join our NPI/Tech Transfer team and be at the forefront of innovation, supporting New Product Introductions and Technical Transfers. This is an exciting opportunity to bring your energy, knowledge, and leadership to a dynamic team dedicated to advancing health solutions. Responsibilities Supporting New Product Introductions/Technical Transfers Provide process, technical, and validation support operations including ongoing support of manufacturing processes and support for new product introduction Conduct analytical/engineering studies associated with the development of new components, products, processes systems, and facilities Coordinate, design, and execute equipment qualification and validation as required Serve as technical and/or validation support 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 notifications by authoring/reviewing/approving investigations Execute equipment commissioning and qualification programs Execute 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 based on conclusions from data analysis Support continuous improvement through Lean Six Sigma methodologies Lead and actively participate in projects, system failure investigations, and investigation reports Execute/develop change controls Contribute to Kaizen events as appropriate Perform root cause analysis of system failures and implement corrective actions through the change management system Serve as technical engineering representative for internal technical group discussions and represent the 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 with Global Policies, Procedures, and Guidelines, regulatory requirements, and execute current Good Manufacturing Practices (cGMP) in daily activities Ensure compliance through documentation completion, risk assessments, closing out corrective actions, participating in audits and inspections, and proactively highlighting any compliance issues Work collaboratively to drive a safe and compliant culture on site Perform other duties as assigned Qualifications Required Currently studying Bachelor’s Degree or higher in a Science, Engineering, or other Technical discipline Knowledge of regulatory/code requirements to Irish, European, and International Codes, Standards, and Practices Excellent communication, presentation, and interpersonal skills to interface effectively with all levels of colleagues and external customers in a team-oriented manner Understanding of the specific responsibilities of all site departments as they relate to one’s own department and the business processes it supports PQ20 Required Skills: Analytical Problem Solving, Analytical Problem Solving, Biopharmaceutical Industry, Biopharmaceuticals, Change Management, Clinical Research, Corrective Action Management, Data Analytics, Database Management, Data Entry, Data Visualization, Document Management, Equipment Qualification, GMP Compliance, Good Manufacturing Practices (GMP), Health Economics, Lean Six Sigma (LSS), Manufacturing Support, Office Applications, Process Improvements, Production Support, Project Management, Regulatory Requirements, Reporting and Analysis, Six Sigma {+ 2 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, Rah