Manufacturing Engineer

Overview of a Process Engineering role

The company is currently recruiting for a key position in their Process Engineering Group.

This hybrid role involves technical support for new product introduction (NPI) and commercial manufacturing, as well as participation in cross-functional or single-function teams.

The successful candidate will have prior related work experience, ideally in manufacturing, preferably in a GMP setting but may also consider applicants from other working environments with technology transfer experience.

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.

The Engineers' support internal and external manufacturing operations to remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

• 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 the organization 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 cGMP and compliance and decisions made. Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance
• Work collaboratively to drive a safe and compliant culture
• May be required to perform other duties as assigned

• 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 of 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
• 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 all levels of colleagues and with external customers in a team-oriented manner

Interested candidates should submit an updated CV.

Please click the link below to apply, or alternatively send an up-to-date CV.

• Associate

• Contract

• Manufacturing

• Medical Equipment Manufacturing
• Pharmaceutical Manufacturing
• Biotechnology Research

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