Engineering Lead
Core
Lead engineering aspects for large-scale projects and new equipment introductions within PCI Pharma Services' Ireland operations, ensuring compliance with cGMP and regulatory standards.
Role type
Senior Engineering Lead (Project & Equipment)
Builds
New product introductions (NPI), new tooling & equipment, compliant manufacturing lines
Domain
Biopharma / Pharmaceutical Manufacturing
Required skills
Project management, Engineering project execution, Equipment design & qualification, Validation processes (FAT/SAT), Budget management, Risk assessment, Cross-functional leadership, Regulatory compliance (cGMP/GEP), Team mentorship
Preferred skills
Capital Expenditure (CapEx) planning, Process improvement, Market trend analysis, Change control management
Technologies
User Requirement Specification (URS), Standard Operating Procedures (SOPs), Good Engineering Practice (GEP), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT)
Responsibilities
Own large-scale project progress and status; Lead engineering support for New Product Introductions (NPI) and new equipment; Manage project budgets and CapEx requests; Coordinate FAT and SAT; Ensure compliance with cGMP and EHS standards; Mentor junior staff and develop team capabilities.
Seniority
Senior, hands-on IC with leadership responsibilities
