NPI Process Engineer

NPI/Tech Transfer Engineer
Hybrid - Carlow
11 month contract
AMC21925

I am currently looking for Process Engineers with New Product introduction experience for an new exciting project with a biopharmaceutical client in Carlow.

In this role you 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.

If you have a bachelors degree and at least 3 years experience working in Process Engineering in a pharmaceutical environment including Tech transfer or New product introduction this could be the role for you!

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. 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.

• Bachelors Degree in Science, Engineering or other Technical discipline
• New product introduction and or tech transfer experience
• 3+ years experience in GMP setting
• Equipment and process validationexperience
• Sterile filling processes and equipmentexperience
• Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment desirable