Plant Engineer
Core
Execute engineering projects and oversee plant maintenance, calibration, and validation in a pharmaceutical CDMO environment to support drug formulation manufacturing.
Role type
Mid-level plant engineer (pharmaceutical manufacturing)
Builds
Liposomal drug products and parenteral lipid nanoparticle formulations
Domain
Pharmaceutical manufacturing / CDMO
Required skills
Project management, equipment calibration, maintenance scheduling, CQV (commissioning, qualification, validation), root cause analysis, engineering drawing review, cGMP/GLP compliance, risk assessment, continuous improvement
Preferred skills
IT/OT and Computer System Validation knowledge, GEP and ISPE standards interpretation, Lean Six Sigma, Design for Six Sigma
Technologies
Extruders (LIPEX® line), manufacturing equipment, validation software
Responsibilities
Execute assigned projects using Project Management methodologies in alignment with Good Engineering Practices (GEP). Oversee and execute calibration activities for manufacturing equipment. Implement maintenance schedules to maximize equipment reliability. Support commissioning, qualification, and validation (CQV) activities. Collaborate with cross-functional teams to troubleshoot equipment/asset issues. Conduct regular inspections and audits of equipment and systems. Identify Continuous Improvement opportunities related to maintenance. Read and review engineering drawings. Follow SOP's, cGMP, and GLP regulations. Initiate and/or support the creation and resolution of engineering related Deviations, CAPAs, and Change Controls. Support with internal and client-driven audits. Review and approve validation protocols.
Seniority
Mid-level, hands-on IC
