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 Responsibilities
* Lead 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 & Qualifications
* Degree:
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.