CQV Engineer: GMP Commissioning & Qualification

20BLOC, Inc.; Thousand Oaks, Northern (CA, KY); Hybrid; USD 70,000 - 115,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Life insurance

401(k) plan

Paid time off

Job summary

20BLOC INC. in Thousand Oaks, CA seeks a CQV-focused professional to create and execute IQ/OQ/PQ protocols and related documentation for GMP equipment and systems. The role emphasizes field execution, risk assessment, and close collaboration with Engineering, Manufacturing, and Quality teams.

Ideal candidates have 2–5 years of CQV or GMP experience, a technical degree, and strong technical writing skills. This is an on-site, full-time role offering competitive compensation and benefits.

Qualifications

• Bachelor’s degree in engineering, life sciences, or an equivalent technical discipline.
• 2–5 years in commissioning, qualification, CQV, manufacturing, or GMP roles.
• Hands-on CQV execution in clinical or biopharma contexts is preferred.
• Familiarity with CSV, FDA 21 CFR Part 11, and GMP documentation.

Responsibilities

• Generate, review, revise, and execute CQV documentation (URS, RTMs, IQ/OQ/PQ).
• Execute commissioning/qualification protocols for GMP equipment and systems.
• Support protocol lifecycle from drafting to closeout and deviations.
• Coordinate with Engineering, Manufacturing, Quality, Facilities, and vendors.
• Draft and revise SOPs, work instructions, and GMP docs as needed.
• Investigate discrepancies, perform impact assessments, and implement CAPAs.
• Oversee system walkdowns, turnover reviews, and punch list closure.
• Own CQV deliverables and execution workstreams appropriate to experience.

Skills

CQV execution

Technical writing

GMP knowledge

Risk assessment

Cross-functional coordination

Education

Bachelor’s degree in engineering or life sciences

Job description

20BLOC INC. in Thousand Oaks, CA seeks a CQV-focused professional to create and execute IQ/OQ/PQ protocols and related documentation for GMP equipment and systems. The role emphasizes field execution, risk assessment, and close collaboration with Engineering, Manufacturing, and Quality teams.

Ideal candidates have 2–5 years of CQV or GMP experience, a technical degree, and strong technical writing skills. This is an on-site, full-time role offering competitive compensation and benefits.