Project And Qualification Engineer Associate

Lonza Group

Tampa, FL, US
Competitive compensation; performance-related bonu...
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Bachelor's degree in engineering
Cgmp regulated environment experience
Iq/oq/pq execution and authoring
** Lonza Group is seeking a Project and Qualification Engineer Associate in Tampa, FL, to lead engineering and qualification projects to ensure compliance and readiness of equipment and facilities. Candidates should possess a bachelor's degree in engineering and experience in a regulated cGMP environment, particularly in project execution and validation processes. **

Job Summary

  • This role involves owning the full project lifecycle from conceptual design through handover to ensure life-changing medicines reach patients safely.
  • Candidates will manage capital and expense projects while coordinating contractors and vendors to execute work compliantly within GMP standards.
  • The position offers a competitive compensation package including performance bonuses, comprehensive medical benefits, and 401(k) matching.

Matching Summary

Match Score: 75

** Lonza Group is seeking a Project and Qualification Engineer Associate in Tampa, FL, to lead engineering and qualification projects to ensure compliance and readiness of equipment and facilities. Candidates should possess a bachelor's degree in engineering and experience in a regulated cGMP environment, particularly in project execution and validation processes. **

Salary

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

Skills & Requirements

Must-have

  • Bachelor's degree in engineering
  • cGMP regulated environment experience
  • IQ/OQ/PQ execution and authoring
  • URS and risk assessment creation
  • Scope, schedule, and budget management
  • Deviation investigation and CAPA tools

Nice-to-have

  • Oral Solid Dosage (OSD) manufacturing exposure
  • FDA/EMA inspection experience
  • Cleanroom operations knowledge
  • OT/IT interface familiarity
  • EHS expectations awareness

Key Requirements

  • Bachelor's degree in engineering or related field
  • Proficient experience in cGMP pharma/biotech environment
  • Hands-on IQ/OQ/PQ skills for GMP systems
  • Strong data integrity mindset with 21 CFR Part 11 knowledge

Work Rights

Not specified

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