Responsibilities:
- Provide on-the-floor shift support for operations staff for technical, training, and process support; at times execute production activities.
- Evaluate process/protocols and real-time deviations; provide assessments to cross-functional process teams.
- Execute equipment commissioning and qualification testing under guidance of C&Q.
- Conduct and document production using digital manufacturing batch records and applicable SOPs; follow cGLP/cGMP, quality/regulatory requirements.
- Document and assess improvement opportunities from operators.
- Coordinate corrective maintenance with area maintenance; lead Safety and Quality investigations and author reports.
- Support Foundry technology transfers; serve as a resource for operational improvement projects.
- Create project plans for process campaigns/changeovers (e.g., cleandown, piping, maintenance, equipment setup) and coordinate/oversee execution to meet timelines.
- Work cross-functionally with PE, PTE, PRD, HSE, and QA; represent operations in Process Hazard Review (PHR) and other HSE venues.
- Promote continuous improvement of changeover workflows; collaborate in a fast-paced team.
Basic Requirements:
- Bachelorโs or Associateโs degree in science/engineering OR technical field or HS Diploma/GED with 5+ years directly applicable pharmaceutical manufacturing experience (Small Molecule, Biologics, or Mixed Modalities), including operations, safety/quality incident investigations, authoring procedures/instructions, and process hazard reviews.
- Authorization to work in the United States full-time; no visa sponsorship.
Additional Preferences:
- Pharmaceutical Product R&D; GMP cleaning/changeover/maintenance support; formal project management training; leadership/influencing; startup experience; FDA/cGMP knowledge; lean principles; troubleshooting; technical communication and technical math/nomenclature; written/verbal/electronic communication.
Application/Other Information (Role):
- On-site MโF schedule with flexibility for 24/7 operations as needed; travel ~5%.