New Product Introduction, Technical Engineering Internship

Job Description

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.

• →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

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

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Current Contingent Workers apply HERE