Qa Validation

Lonza Group

Portsmouth, NH, US
Not specified; performance-related bonus; medical,...
Onsite
Bachelor's degree in engineering or life sciences
5 years validation experience in gmp environment
Iq/oq/pq and process validation lifecycle knowledge
Lonza Group is seeking a QA Validation professional for their Portsmouth, NH office, focusing on compliance with cGMP standards and overseeing validation activities across various systems. The role requires a detail-oriented individual with at least 5 years of experience in a GMP-regulated environment, particularly in validation and qualification processes

Job Summary

  • This role is critical for ensuring compliance with cGMP standards and regulatory requirements while partnering cross-functionally to drive quality.
  • The position involves leading validation lifecycle activities including equipment qualification and developing protocols to ensure regulatory adherence.
  • Candidates will receive a comprehensive benefits package including performance-related bonuses, medical insurance, and 401(k) matching.

Matching Summary

Match Score: 85

Lonza Group is seeking a QA Validation professional for their Portsmouth, NH office, focusing on compliance with cGMP standards and overseeing validation activities across various systems. The role requires a detail-oriented individual with at least 5 years of experience in a GMP-regulated environment, particularly in validation and qualification processes.

Salary

Not specified; Performance-related bonus; Medical, dental, vision, 401(k), life, disability, PTO

Skills & Requirements

Must-have

  • Bachelor's degree in Engineering or Life Sciences
  • 5 years validation experience in GMP environment
  • IQ/OQ/PQ and process validation lifecycle knowledge
  • Risk-based validation strategy execution
  • Utilities qualification for HVAC and water systems

Nice-to-have

  • CSV experience with computerized systems
  • Proficiency in TrackWise, SAP, LIMS, or KNEAT
  • Strong analytical and decision-making skills
  • Experience with change control and CAPA processes
  • Excellent cross-functional communication abilities

Key Requirements

  • BS in Engineering, Life Sciences, or related field
  • Minimum 5 years of GMP validation experience
  • Solid understanding of FDA and EMA regulatory expectations

Work Rights

Not specified

Tailored Resume

Cover Letter