Overview
PSC Biotech is seeking a Bioprocess Engineer to join our client’s team in Limerick. This role provides both technical process design support for bio process systems on new CAPEX projects and ongoing operational support for commercial manufacturing processes.
Key Responsibilities
CAPEX / Project Support
* Generate User Requirement Specifications (URS) for assigned systems.
* Review and approve Basis of Design (BOD) and detailed design deliverables (e.g., PFDs, P&IDs).
* Track and resolve HAZOP action items, ensuring integration into system design.
* Participate in 30%, 60%, and 90% design model reviews to confirm compliance with operational, safety, and ergonomic standards.
* Review and approve system lifecycle documentation (FS, SDS, IO lists, etc.).
* Support FAT/SAT and commissioning activities, including development of protocols.
* Ensure Vendor Document Requirements (VDR) meet client standards.
* Build Preventative Maintenance (PM) tasks and spare parts lists on CMMS.
Operational / Manufacturing Support
* Act as a technical SME for assigned bioprocess equipment and systems.
* Support manufacturing operations through troubleshooting, deviation resolution, and root cause analysis.
* Monitor process performance, analyze data trends, and recommend improvements.
* Provide technical input to change controls, CAPAs, and risk assessments.
* Support technology transfer activities, ensuring successful scale-up and integration of new processes into manufacturing.
* Collaborate with Manufacturing, QA, and Process Sciences to ensure robust and compliant operations.
* Drive continuous improvement initiatives to enhance reliability, yield, and efficiency.
Requirements
* Bachelor’s degree in chemical, Process, or Mechanical Engineering (or equivalent).
* 3–5 years of relevant engineering experience; direct experience with biopharmaceutical process equipment preferred.
* Background in process design, commissioning, and/or manufacturing support within the biopharmaceutical sector is highly desirable.
* Strong problem-solving and data analysis skills with the ability to support root cause investigations.
* Familiarity with automation platforms such as DeltaV is an advantage.
* Equivalent experience may be considered in place of formal education.
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Engineering and Manufacturing
Industries
* Pharmaceutical Manufacturing and Medical Equipment Manufacturing
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