About PSC Biotech
We are a leading Biotech Consultancy firm founded in 1996, with Global operations in Ireland, India, Singapore, Australia and the US. We serve 350 clients in more than 23 countries worldwide.
Job Description:
A new exciting opportunity exists for a Process Engineer to join our Site and report to the Technical Engineering Manager. You will serve as technical support for new product introduction (NPI) and commercial manufacturing with a particular focus on automated visual inspection.
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 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;
* Work collaboratively to drive a safe and compliant culture;
Requirements:
* Bachelor's Degree or higher required; ideally in a Science, Engineering or other Technical discipline;
* Preferably Min 1 year experience ideally in manufacturing, preferably GMP Setting;
Desirable Skills:
* 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;
* Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices;
Working Environment:
Hybrid working model typically 2-3 days on site.