CSV Validation Consultant I – GMP Compliance

Clark & Enersen; Glendale (CA); Sur place; USD 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Health insurance

Dental insurance

Vision insurance

401(k) with match

Paid time off

Résumé du poste

ELIQUENT Life Sciences in Glendale, CA seeks CSV Consultants at multiple levels to support validation and compliance activities in a regulated GMP environment. You will execute validation deliverables, ensure data integrity, and maintain inspection readiness across manufacturing, laboratory, and IT systems, collaborating with cross-functional teams.

Qualifications include a bachelor’s in engineering/science, knowledge of GMP and regulatory standards, and strong documentation and communication

Qualifications

• Bachelor’s degree in Engineering, CS, Life Sciences, or related field.
• Knowledge of GMP, GAMP 5, 21 CFR Part 11, EU Annex 11.
• Strong documentation, communication, and organizational skills.
• Ability to work independently and within cross-functional teams.
• Consulting mindset with adaptability to dynamic project needs.

Responsabilités

• Author and/or review CSV documentation, including validation plans, protocols, reports, and requirements.
• Execute validation testing and document results per GMP/GLP.
• Support ongoing system lifecycle management: periodic reviews, requalification, and change control.
• Collaborate with cross-functional teams (Quality, IT, Engineering, Operations, Automation).
• Provide support during audits and inspections to meet regulatory expectations.
• Ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, and company SOPs.

Connaissances

Documentation

Communication

Organizational skills

Formation

Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field

Description du poste

ELIQUENT Life Sciences in Glendale, CA seeks CSV Consultants at multiple levels to support validation and compliance activities in a regulated GMP environment. You will execute validation deliverables, ensure data integrity, and maintain inspection readiness across manufacturing, laboratory, and IT systems, collaborating with cross-functional teams.

Qualifications include a bachelor’s in engineering/science, knowledge of GMP and regulatory standards, and strong documentation and communication