Process Engineer - Tech Transfer / NPI
This role serves as technical support for new product introduction (NPI) and commercial manufacturing, participating in cross-functional or single-function teams with vendors or above-site groups.
Responsibilities
* Design, author, review, approve, and execute qualification/validation documentation and process development studies according to the standard approval process.
* Develop and execute change controls.
* Provide technical input into quality notifications by authoring, reviewing, and approving investigations.
* Execute equipment/qualification validation programs, including re-qualification and re-validation.
* Sustain continuous improvement through Lean Six Sigma methodologies.
* Analyze system failures and substandard performance using standard tools and methods to resolve machine and system issues.
* Represent technical operations at global technical forums.
* E nsure compliance with Global Policies, Procedures, and Guidelines, regulatory requirements, and current Good Manufacturing Practices (cGMP) in daily activities and job functions.
* Maintain documentation completion, risk assessments, corrective actions, audit participation, and issue highlighting around compliance.
* Manage stakeholders across multiple decision-makers, corporate colleagues, and cross-functional teams by demonstrating trust relationships at all levels.
Requirements
* Bachelor's Degree or higher preferred, ideally in a Science, Engineering, or Technical discipline.
* Minimum 3 years of experience, ideally in manufacturing, preferably GMP Setting.
* Proven experience leading technical projects.
* Continuous professional development evidence desirable.
* Knowledge of process monitoring systems, automation systems (Delta V), operational intelligence & data systems (Pi System) within a GMP manufacturing environment beneficial but not necessary.
* Familiarity with regulatory/code requirements for Irish, European, and International Codes, Standards, and Practices.
* Report, standards, policy writing skills required.
* Equipment and process validation expertise.
* Sterile filling processes and equipment knowledge.
* Proficiency in Microsoft Office and job-related computer applications required.
* Excellent communication, presentation, and interpersonal skills for team-oriented collaboration.