Sr. QA Engineer

Senior QA Engineer

Location: Tampa, FL

Step into a senior role where you will provide technical leadership across quality, validation, engineering, and lifecycle activities. As a Sr. QA Engineer, you will help guide teams, influence critical decisions, and ensure our systems and processes meet the highest cGMP and industry standards.

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 the quality review and approval of engineering and validation documentation, including IQ/OQ/PQ/PPQ protocols, master plans, risk assessments, and periodic reviews.

• Partner with internal and external engineering teams to support new system installations, ensuring all commissioning and qualification activities comply with cGMP.

• Support and influence the full Validation Life Cycle from design through ongoing operation, continuous improvement, and revalidation.

• Represent QA on cross‑functional teams supporting facility buildouts, laboratory moves, commissioning efforts, and computerized system validation initiatives.

• Create, review, and approve Change Controls, CAPAs, SOPs, deviations, and other quality system documentation.

• Serve as a senior point of contact across Manufacturing, Packaging, Engineering, MSAT, PD, and QA/QC to resolve issues, manage risks, and implement compliant process improvements.

• Lead or facilitate quality system enhancements, contribute to audit readiness, support regulatory and client audits, and maintain key Quality metrics and KPIs.

What we are looking for:

• Bachelor's degree, ideally in a scientific/technical/engineering discipline.

• Extensive experience in a pharmaceutical cGMP environment.

• Strong expertise with validation lifecycle activities and Quality System documentation (IQ/OQ/PQ/PPQ, risk assessments, Change Controls, CAPAs, deviations).

• Proven ability to lead cross‑functional initiatives and influence technical decision‑making.

• Experience supporting audits and sustaining a constant state of inspection readiness.

• Strong understanding of equipment, utilities, automation, computer systems, and laboratory instrumentation from a QA and validation perspective.

• Excellent analytical, communication, and problem‑solving skills, with the ability to mentor and guide junior team members.

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.