Project and Qualification Engineer

Lonza•Tampa, FL

1d•Onsite

About The Position

Lead end-to-end engineering projects and qualification activities at a regulated oral solid dose (OSD) pharmaceutical manufacturing site. Drive scope, schedule, budget, and validation deliverables to keep equipment, utilities, and facilities compliant and inspection-ready.

Requirements

Bachelor’s degree in Engineering (or closely related field) required.
Ability to work in manufacturing/utility areas with required PPE; occasional lifting (up to ~25 lbs) and travel to vendors/sites as needed.
Demonstrated experience in engineering project execution and qualification within FDA-regulated/GxP environments (pharma cGMP strongly preferred).
Hands-on planning and field execution of IQ/OQ (and PQ where applicable), including alarm/interlock testing, functional verification, deviations management, and final reporting.
Proven ability to author/manage URS, System Classification/GxP impact, risk assessments (FMEA), commissioning plans/scripts, protocols, trace matrices, turnover packages (FAT/SAT, calibration/material certs, as-builts, manuals, spares, training).
Demonstrated success managing scope, schedules, budgets, contractors, and stakeholders; strong risk management and executive-ready reporting.
Skilled in RCA tools (FMEA, Fishbone, 5 Whys), deviation/non-conformance management, and CAPA development through effective closure; strong data integrity mindset (e.g., 21 CFR Part 11 awareness).
Clear, structured communicator who partners effectively with Engineering, Maintenance, Operations, Quality, Analytical, R & D, EHS, OT/IT, and vendors on routine basis; capable of mentoring contractors and peers.

Responsibilities

Lead projects through the full lifecycle—concept/design, procurement, construction/installation, start-up, commissioning, qualification (IQ/OQ/PQ), and handover to owning department—meeting scope, schedule, budget, safety, and quality targets.
Own planning and controls: define scope and milestones; build and manage schedules and budgets; forecast, track, and report progress, risks, and mitigations to leadership.
Coordinate internal teams and external partners (OEMs, integrators, construction vendors); provide technical coaching and ensure work meets engineering standards, cGMP, safety, and documentation requirements.
Plan and execute commissioning and qualification for equipment, utilities, and facilities; author/manage URS, System Classification, risk assessments, commissioning plans, IQ/OQ/PQ protocols, traceability matrices, and final reports.
Develop initial lifecycle documents and technical content (SOPs, PMs, calibration/operations instructions, troubleshooting guides, turnover templates); support initial training prior to hand over.
Lead and support change control, compliance, and audits—ensuring documentation (design records, test evidence, validation deliverables) is GDP-compliant, traceable, and inspection-ready.
Conduct structured investigations (RCA, 5 Whys, FMEA); drive CAPA effectiveness; ensure smooth operational readiness with PMs, calibration, spare parts, and training to maintain validated state.