Lonza
pharmaceutical manufacturing
ProjectandQualificationEngineer
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Project and Qualification Engineer at Lonza. Skills: engineering project execution, qualification, FDA-regulated environments, cGMP. Lead end-to-end engineering projects. Lead qualification activities”
What You'll Achieve.
Keep equipment, utilities, and facilities compliant and inspection-ready; Ensure work meets engineering standards, cGMP, safety, and documentation requirements; Ensure documentation is GDP-compliant, traceable, and inspection-ready; Ensure smooth operational readiness with PMs, calibration, spare parts, and training; Maintain validated state
Industry & Context.
Conduct structured investigations (RCA, 5 Whys, FMEA); Drive CAPA
Ability to work in manufacturing/utility areas, occasional lifting (up to ~25 lbs), travel to vendors/sites as needed
What They're Looking For.
Must Have
Bachelor’s degree in Engineering, Demonstrated experience in engineering project execution and qualification within FDA-regulated/GxP environments, Hands-on planning and field execution of IQ/OQ (and PQ where applicable), Proven ability to author/manage URS, System Classification/GxP impact, risk assessments (FMEA), commissioning plans/scripts, protocols, trace matrices, turnover packages, Demonstrated success managing scope, schedules, budgets, contractors, and risk management and executive-ready reporting, Skilled in RCA tools (FMEA, Fishbone, 5 Whys), deviation/non-conformance management, and CAPA development
Nice to Have
pharma cGMP strongly preferred, 21 CFR Part 11 awareness
What You'll Do.
Lead end-to-end engineering projects
Lead qualification activities
Lead projects through full lifecycle
Own planning and controls
Define scope and build schedules
Manage schedules and forecast
Track and report progress
Coordinate internal teams and external partners
Provide technical coaching
Ensure work meets standards
Plan and execute commissioning and qualification
System Classification
Develop initial lifecycle documents
Develop technical content
Support initial training
Lead and support change control
Ensure documentation is GDP-compliant
Conduct structured investigations
Ensure smooth operational readiness
Maintain validated state
How You'll Work.
Team & Collaboration
Coordinate internal teams and external partners; Partner effectively with Engineering, Maintenance, Operations, Quality, Analytical, R&D, EHS, OT/IT, and vendors; Mentor contractors and peers
Communication Scope
Clear, structured communicator
Process & Methodology
Lead end-to-end engineering projects, Drive scope, schedule, budget, validation, Manage schedules and forecast, Track and report progress, risks, mitigations, Manage scope, schedules, budgets, contractors, and risk management
Full Job Description
**Project & Qualification Engineer** **Location:** Tampa, FL 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. **What you will get:** A competitive compensation. In addition, below you will find a comprehensive summary of the benefits package we offer: * Performance-related bonus. * Medical, dental and vision insurance. * 401(k) matching plan. * Life insurance, as well as short-term and long-term disability insurance. * Employee assistance programs. * Paid time off (PTO). Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge. **What you will do:** * 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 (desi
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