Project and Qualification Engineer

Lonza•Tampa, FL

1d•Onsite

About The Position

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 (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. What we are looking for: 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. About Lonza At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board. Ready to shape the future of life sciences? Apply now.

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.