Project and Qualification Engineer Associate

Lonza • Tampa, FL

1d

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level