Senior CQV & Validation Program Lead

BioSpace; Irvine (CA); Sur place; USD 125 000 - 135 000; Plein temps

Avantages offerts par ce poste

Medical, Dental, Vision

401K

PTO

Résumé du poste

Siegfried Irvine site is seeking a CQV leader to oversee commissioning, qualification, and validation across facilities, utilities, and equipment. You will manage the Site Validation Master Plan, coordinate cross-functional teams, and ensure compliance with cGMPs and regulatory expectations.

The role emphasizes leadership, project coordination, and hands-on validation work within a fast-growing pharmaceutical manufacturing environment.

Qualifications

• Bachelor's degree in engineering, science, or related technical discipline.
• 6–10 years of experience in an FDA or GMP-regulated environment.
• Pharmaceutical industry experience preferred.
• 3–5 years of supervisory experience.

Responsabilités

• Own and manage the Site Validation Master Plan and related qualification activities.
• Oversee qualification of facility, utility, equipment, sterilization, aseptic, process, cleaning, and analytical methods.
• Coordinate CQV activities with Project Management, Engineering, MS&T, and Operations.
• Lead QA Sterilization Validation group and oversee consultants.
• Represent CQV in regulatory inspections and client audits.

Connaissances

CQV experience

GMP compliance

Team leadership

Project coordination

QA documentation

Formation

Bachelor's degree in engineering or science

Description du poste

Siegfried Irvine site is seeking a CQV leader to oversee commissioning, qualification, and validation across facilities, utilities, and equipment. You will manage the Site Validation Master Plan, coordinate cross-functional teams, and ensure compliance with cGMPs and regulatory expectations.

The role emphasizes leadership, project coordination, and hands-on validation work within a fast-growing pharmaceutical manufacturing environment.