Seeking experienced Process Engineer to lead project workstreams and ensure successful delivery of site capital projects.
This role will focus on a large-scale capacity expansion project involving the construction of a high-volume oral solid dose (OSD) manufacturing facility.
Responsibilities:
- Ensure all work meets company policies, cGMP, SOP, and regulatory standards.
- Take ownership of quality compliance in engineering activities.
- Oversee equipment qualification and process validation for quality compliance.
- Support project charters, scope definition, and schedule management.
- Plan, execute, and document project schedules, training, and handover.
- Coordinate external contractors and liaise with internal departments to meet project deadlines.
- Draft and review validation documents (SOPs, protocols, reports).
- Investigate deviations and apply structured problem-solving to resolve project issues.
- Manage contractor budgets, approvals, schedules, and compliance with site procedures.
- Build relationships with contractors and ensure their adherence to site requirements.
- Provide regular updates on schedule, cost, scope, and risks.
Requirements:
- Minimum degree level or equivalent in an Engineering discipline.
- 3-6 years of engineering experience working in an oral solid dose pharmaceutical manufacturing (or comparable) environment.
- Previous project management experience and/or qualification is a distinct advantage.