Senior CQV Manager - GMP Validation & Sterilization

Siegfried; Irvine (CA); On-site; USD 125,000 - 135,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Flexible Spending & HSA Options

Life Insurance, Short & Long Term DI

Pet Insurance

Generous PTO, Sick & Holiday Time Off

401K

Job summary

Siegfried in Irvine, CA seeks a senior CQV leader to oversee commissioning, qualification and validation for drug products, devices, and manufacturing processes. You will own the site validation strategy and manage master plans, protocols and reports, coordinating cross-functional teams and external consultants.

Ideal candidates have 6–10 years in FDA/GMP environments, aseptic manufacturing experience, and strong leadership.

Qualifications

• Experience with commissioning, qualification, and validation activities within Site Validation Master Plan.
• Ability to delegate responsibilities and coordinate across functional areas.
• Strong analytical, communication, and technical writing skills; GMP documentation experience.
• Experience in GMP environments; aseptic manufacturing preferred.

Responsibilities

• Own and manage the site validation strategy, rationale, and approach.
• Oversee Site Validation Master Plan activities and approve qualification documents.
• Coordinate validation life cycle for existing and new products and projects.
• Lead QA Sterilization Validation and manage consultants as needed.
• Support regulatory inspections and client audits related to CQV.

Skills

CQV expertise

GMP compliance

Leadership

Project coordination

Regulatory inspections

Education

Bachelor's degree in engineering/science

Tools

Validation software suites

Job description

Siegfried in Irvine, CA seeks a senior CQV leader to oversee commissioning, qualification and validation for drug products, devices, and manufacturing processes. You will own the site validation strategy and manage master plans, protocols and reports, coordinating cross-functional teams and external consultants.

Ideal candidates have 6–10 years in FDA/GMP environments, aseptic manufacturing experience, and strong leadership.