Deviation Investigator II - Lead RCA & CAPA

Lonza; Portsmouth (NH); On-site; Confidential; Full time

Benefits offered by this job

Career growth

Insurance package

Collaborative culture

Life-changing therapies support

Job summary

Lonza in Portsmouth, NH is seeking a Deviations Investigator II to lead deviation investigations in a cGMP environment. The role emphasizes root-cause analysis, CAPA development, mentoring junior investigators, and high-quality documentation.

This on-site position follows a Monday–Friday schedule, 8:00am–4:30pm, with cross-functional collaboration across teams to ensure compliance. Candidates should have a Bachelor’s degree in Life Sciences or Engineering with 3–5+ years of GMP experience,

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field.
• 3–5+ years of experience in a GMP-regulated environment.
• Strong knowledge of cGMP, GDP, and data integrity.

Responsibilities

• Independently lead and complete minor deviation investigations.
• Support major deviation investigations with guidance.
• Mentor Level I investigators to raise team capability.
• Make real-time decisions on deviation containment and approach.
• Use RCA tools (5 Whys, fishbone, cause mapping) to drive investigations.
• Manage a moderate workload of concurrent investigations with high quality.
• Develop and implement CAPAs to prevent recurrence.
• Ensure compliance with cGMP, GDP, and data integrity standards.

Skills

Deviation investigations

CAPA development

Root cause analysis

Mentoring

Documentation

Cross-functional collaboration

Decision making

Microsoft Office

Education

Bachelor’s degree in Life Sciences or Engineering

Tools

Microsoft Office

Documentation tools

Job description

Lonza in Portsmouth, NH is seeking a Deviations Investigator II to lead deviation investigations in a cGMP environment. The role emphasizes root-cause analysis, CAPA development, mentoring junior investigators, and high-quality documentation.

This on-site position follows a Monday–Friday schedule, 8:00am–4:30pm, with cross-functional collaboration across teams to ensure compliance. Candidates should have a Bachelor’s degree in Life Sciences or Engineering with 3–5+ years of GMP experience,