Project And Qualification Engineer

Lonza Group

Tampa, FL, US
Competitive compensation; performance-related bonu...
Not specified
Bachelor's degree in engineering
Iq/oq/pq execution experience
Fda-regulated gxp environments
Lonza Group is seeking a Project and Qualification Engineer to lead engineering projects and qualification activities at a regulated pharmaceutical manufacturing site in Tampa, FL. The role requires expertise in project execution within FDA-regulated environments, emphasizing compliance and quality standards

Job Summary

  • This role leads the full lifecycle of engineering projects from concept to handover while ensuring compliance with cGMP standards.
  • Candidates will be responsible for authoring critical documentation including URS, risk assessments, and IQ/OQ/PQ protocols for equipment and facilities.
  • The position offers competitive compensation including performance bonuses, comprehensive medical benefits, and a 401(k) matching plan.

Matching Summary

Match Score: 85

Lonza Group is seeking a Project and Qualification Engineer to lead engineering projects and qualification activities at a regulated pharmaceutical manufacturing site in Tampa, FL. The role requires expertise in project execution within FDA-regulated environments, emphasizing compliance and quality standards.

Salary

Competitive compensation; Performance-related bonus; Medical, dental, vision, 401(k), life, disability, PTO

Skills & Requirements

Must-have

  • Bachelor's degree in Engineering
  • IQ/OQ/PQ execution experience
  • FDA-regulated GxP environments
  • URS and risk assessment authoring
  • Commissioning and validation planning

Nice-to-have

  • Strong data integrity mindset
  • Experience with 21 CFR Part 11
  • Ability to mentor contractors
  • Effective executive-ready reporting

Key Requirements

  • Bachelor's degree in Engineering or related field
  • Demonstrated experience in FDA-regulated pharma environments
  • Hands-on IQ/OQ/PQ and commissioning execution skills

Work Rights

Not specified

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