Process Engineer - Tech Transfer

Contract: 11 month contract
Hours: Full-time, Hybrid. Day's role with expectation to support shift intermittently when Floor activities/studies are ongoing.
Salary: To be discussed
Location: Co. Carlow

New exciting opportunity now exists on our Carlow Site for a Process Engineer to join the Process Engineering Group on site and report to the Technical Engineering Manager

Our new team member will serve as technical support for new product introduction (NPI) and commercial manufacturing and 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 we will consider applicants from other working environments as long as they have 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 for this role.

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.
• 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. Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.

Skills & Knowledge:

• 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
• Demonstratable 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
• 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.

If you hold a VALID WORK PERMIT for IRELAND. we would love to hear from you, if however, you do not hold a valid work permit for Ireland unfortunately we will not be in a position to assist you with your job search with regard to this role.

Contact: Louise Catherine Kelly | louise.kelly@manpower.ie