Our client, a global hematology device company is currently seeking a Facilities Engineer to join their new state-of-the-art facility. This person will be responsible for developing procedures and systems to assure facility maintenance operations are appropriate, meet good manufacturing practice (GMP) requirements, are within validated parameters and are sufficient in determining the ability for continuing operations.
- Assures facility support systems and critical processes are accurately represented on AutoCAD Drawings
- Assists with environmental, health, and safety (EHS) activities when applicable and appropriate
- Assures alterations, modifications made to critical systems are performed in accordance with current industry practices, cGMP’s, and building and safety codes
- Identifies and makes recommendations for improvements to facility support systems and equipment, creates corrective action plans for deficient equipment and systems
- Assures up-to-date drawings of new and/or existing facilities, machinery, equipment, and processes
- Maintain in conformance all critical system that supports the operations
- Participates in Business Continuity Planning exercises.
- Provides guidance and direction in optimizing plant energy consumption.
- Controls project schedules and budgets
- May be the project leader on Lean/Six Sigma initiatives and Cost Improvement Projects, 5S, Kaizen events
- Bachelor’s or Master’s Degree Engineering required. Mechanical, Electrical, or Chemical Engineering preferred
- 5+ years related experience in a manufacturing environment
- Recent experience working in facilities at regulated environment (medical device/drug manufacturing preferred) operation preferred
- Knowledge of Six Sigma/Lean methods required, Green Belt or Black Belt Certification preferred
- Experience in design, layout, installation and validation of compressed air systems, boilers and steam distribution systems, pure steam generation and distribution systems, DI-RO-WFI systems, process chilled water systems, cooling towers cooling tower water systems, HVAC air handling systems, packaged HVAC systems, control systems, electrical service and distribution
- Experienced with construction, trades, and contracting principles
- Experience with design, construction, operation of controlled environments including ISO 5, 6,7 & 8 clean rooms, laminar flow stations, sterility suites, fume exhaust and bio containment stations
- Experienced with maintenance and servicing of facilities support systems and critical equipment, supervision of contractors and suppliers providing services and materials
- Experience in FDA regulated industry
- Electrical Schematic Print Reading
- Root Cause Analysis
- Support resolution of production plant downtime events
If you are interested in this position, please send your resume to firstname.lastname@example.org