Summary: The Process Engineer role at Orion Group Life Sciences involves providing technical support for new product introduction and commercial manufacturing, particularly focusing on automated visual inspection. The position requires collaboration with cross-functional teams and vendors, ensuring compliance with GMP standards. The ideal candidate will have relevant manufacturing experience and knowledge of process monitoring and automation systems. This is an 11-month contract with potential for extension.

Key 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 Carlow 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
• Work collaboratively to drive a safe and compliant culture in Carlow
• May be required to perform other duties as assigned
• Demonstratable experience of leading technical related projects
• Previous experience with Automated visual inspection systems is desired, but not essential
• 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, 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 all levels of colleagues and with external customers in a team orientated manner

Key Skills:

• Bachelor’s Degree or higher required; ideally in a Science, Engineering or other Technical discipline
• Preferably Min 1 years experience ideally in manufacturing, preferably GMP Setting
• Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment
• Previous experience with automated visual inspection systems
• Continuous professional development evidence
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
• Report, standards, policy writing skills
• Equipment and process validation
• Sterile filling processes and equipment
• Proficiency in Microsoft Office and job-related computer applications
• Excellent communication, presentation and interpersonal skills

Salary (Rate): undetermined

City: Carlow

Country: Ireland

Working Arrangements: undetermined

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other