Job Title: Process Engineer - Tech Transfer / NPI
As a technical support specialist, this role will assist with new product introduction (NPI) and commercial manufacturing. Participate in cross-functional or single-function teams, liaising with vendors or above-site groups.
Key Responsibilities:
* Design, author, review, approve, and execute qualification/validation documentation and process development studies according to the standard approval process.
* Develop and implement 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.
* Maintain compliance with Global Policies, Procedures, and Guidelines, regulatory requirements, and current Good Manufacturing Practices (cGMP).
* Ensure compliance via documentation completion, risk assessments, corrective actions, audits, inspections, and highlighting any compliance issues.
Requirements:
* Bachelor's Degree or higher in a Science, Engineering, or Technical discipline preferred.
* Minimum 3 years of experience in manufacturing, preferably in a GMP setting.
* Demonstrated experience leading technical projects.
* Continuous professional development is desirable.
* Knowledge of process monitoring systems, automation systems (Delta V), operational intelligence & data systems (Pi System) within a GMP manufacturing environment is beneficial.
* Knowledge of regulatory/code requirements for Irish, European, and International Codes, Standards, and Practices.
* Report, standards, policy writing skills required.
* Equipment and process validation.
* Sterile filling processes and equipment.
* Proficiency in Microsoft Office and job-related computer applications required.
* Excellent communication, presentation, and interpersonal skills to interface effectively with colleagues and external customers.