Project and Qualification Engineer Associate

Project & Qualification Engineer Associate

Location: Tampa, FL

Bring new site capabilities online from concept to handover. In this role, you’ll lead end-to-end engineering and qualification projects that ensure our equipment, utilities, and facilities are safe, compliant, and inspection-ready—directly impacting how life-changing medicines reach patients.

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:

• Own the full project lifecycle—from conceptual/detailed design and procurement through installation, start-up, commissioning, qualification (IQ/OQ/PQ), and handover to owning department.

• Manage scope, schedule, and budget for capital and expense projects; forecast and control costs; provide clear progress, risk, and mitigation updates to leadership.

• Coordinate contractors and vendors (OEMs, integrators, construction) to execute work safely and compliantly; ensure alignment with site standards and GMP expectations.

• Lead commissioning & qualification for equipment, utilities, and facility systems; author/manage URS, system classification, risk assessments, commissioning plans, protocols, deviations, and final reports,

• Deliver complete turnover packages (e.g., FAT/SAT, calibration certificates, material certs, as-built drawings, manuals, training docs, and spare parts lists) to enable smooth operational readiness.

• Author and maintain lifecycle documentation—SOPs, initial PM instructions with measurable criteria, calibration requirements, troubleshooting guides—and support training for Operations and Maintenance.

• Ensure compliance via change control, investigations, and CAPA using structured problem-solving (RCA/FMEA/5 Whys); maintain validated state, inspection readiness, and robust GDP documentation.

What we are looking for:

• Bachelor’s degree in engineering or related field required.

• Proficient experience in a regulated cGMP environment (pharma/biotech; OSD a plus) across engineering, validation/qualification, or project execution.

• Hands-on IQ/OQ/PQ for GMP equipment/utilities/facilities; skilled in authoring URS, risk assessments, protocols, test scripts, trace matrices, and final reports.

• Proven ability to manage scope/schedule/budget, coordinate cross-functional stakeholders and vendors, and drive readiness/closeout on time and within budget.

• Experience with deviations, CAPA, and structured root cause tools (FMEA, fishbone, 5 Whys); strong data integrity mindset and familiarity with 21 CFR Part 11.

• Clear, concise documentation (SOPs, PMs, turnover packages) and strong change control/GDP practice; audit-ready deliverables.

• Exposure to FDA/EMA inspections, OT/IT interfaces, EHS expectations, cleanroom operations, and field work preferred; ability to wear PPE and travel between sites as projects require.

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.