We are seeking a hands-on Project Engineer to drive New Product Introduction (NPI) and equipment life cycles within our sterile manufacturing suites. This isn't a "desk-only" role; you will be the technical lead on the floor, transitioning complex systems from design and C&Q into full-scale GMP production.Critical Requirements (Must-Haves)NPI Execution: Proven track record of taking new equipment/processes from concept through to validation and routine manufacturing.Sterile/Cleanroom Expertise: Deep, practical experience operating within Aseptic environments (Grade A/B). You understand the rigors of cleanroom discipline and sterile processing.Biopharma Engineering: A solid foundation in Equipment or Project Engineering specifically within a Biotech or Pharmaceutical GMP setting.Core ResponsibilitiesLead Technical Projects: Scope and execute high-value projects in Formulation, Filling, Lyophilization, and Automated Inspection.Bridge the Gap: Coordinate the introduction of new equipment, troubleshooting mechanical and automation issues before and during start-up.Operational DNA: Develop maintenance programs, optimize spare parts inventory, and author the technical SOPs for new assets.Compliance & Reliability: Manage change controls and lead root cause investigations for equipment deviations within a GDP environment.Experience & QualificationsDegree: Mechanical, Electrical, or Chemical Engineering.Industry: 3+ years in Aseptic/Biopharma manufacturing.Technical Edge: Strong mechanical aptitude with "hands-on" experience in a high-volume, automated environment.Project Tools: Proficiency in MS Project and Change Control systems; ability to hit tight deadlines in a fast-moving NPI cycle.
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