Process Engineer

Role Summary:

• A new opportunity now exists on our client’s pharmaceutical Co. Carlow site for a Process Engineer to join the Process Engineering Group on site and report to the Technical Engineering Manager.
• The Process Engineer will serve as technical support for new product introduction (NPI) and commercial manufacturing with a particular focus on automated visual inspection.
• The ideal candidate will participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
• You will typically have prior related work experience; ideally in manufacturing, preferably GMP Setting but applicants from other appropriate working environments will be considered.
• Knowledge of process monitoring systems, automation systems, operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial.
• Previous experience with automated visual inspection is desired.

Core Duties and 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, participate in audits and inspections and proactively highlighting any issues around compliance.
• Work collaboratively to drive a safe and compliant culture on site.
• May be required to perform other duties as assigned

Minimum Qualifications and Experience:

• Bachelor’s Degree or higher required; ideally in a Science, Engineering or other Technical discipline
• Min 1 year experience ideally in manufacturing, preferably GMP Setting
• Demonstrable 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.

Please note, we do not require agency assistance with this role.