Process Engineer (NPI)

Tandem Project Management Ltd.; Carlow; Hybrid; EUR 55,000 - 75,000; Full time

Job summary

A biopharmaceutical company in Carlow is seeking a Process Engineer to provide technical support for new product introductions and manufacturing operations. The successful candidate will ensure compliance with regulatory standards and contribute to process improvements through Lean Six Sigma methodologies. Candidates should have a relevant Bachelor's degree and at least 3 years of experience in a manufacturing environment. The role offers hybrid working after training completion.

Qualifications

• Minimum 3 years’ experience in a manufacturing environment, preferably GMP.
• Experience in leading technical-related projects.
• Knowledge of regulatory requirements for Ireland and international standards.

Responsibilities

• Design, review, and approve qualification documentation.
• Support continuous improvement efforts.
• Perform root cause analysis on system failures.

Skills

Technical project leadership

Process monitoring systems

Root cause analysis

Lean Six Sigma methodologies

Equipment validation

GMP compliance

Effective communication

Education

Bachelor’s Degree in Science or Engineering

Tools

Microsoft Office

DeltaV

Pi System

Job description

Summary

A Process Engineer is required to join the Process Engineering Group on-site at a biopharmaceutical company in Carlow. The successful candidate will provide technical support for new product introductions (NPI) and commercial manufacturing.

Responsibilities

• Design/Author/Review/Approve/Execute qualification/validation documentation and process development studies in line with the standard approval process.
• Design/Author/Review/Approve/Execute Execution/development of change controls.
• Contribution to Kaizen events as appropriate.
• Technical input into quality notification by authoring/reviewing/approving investigations.
• Execution of equipment/qualification validation programs; including re-qualification and re-validation.
• Support continuous improvement through Lean Six Sigma methodologies.
• Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues.
• Serve as technical engineering representative for internal technical group discussions and represent technical Operations at global technical forums.
• 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, participating in audits and inspections and proactively highlighting any issues around compliance.

Qualifications & Experience

• Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
• Min 3 years’ experience, ideally in manufacturing, preferably GMP setting.
• Demonstrable experience in leading technical-related projects.
• Evidence of continuous professional development is desirable.
• Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable, but not a necessity.
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
• Report, standards, and policy writing skills required.
• Equipment and process validation.
• Sterile filling processes and equipment.
• Proficiency in Microsoft Office and job-related computer applications required.
• Hybrid role, once successful completion of training. Occasional shift support as required based on program needs.