Eliquent Life Sciences
CQV Consultant - Equipment Systems
Eliquent Life Sciences, Irvine, California, United States, 92713
ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health challenges around the world. ELIQUENT is committed to serving clients’ needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices. For more information, please visit our website at eliquent.com.
We are seeking a
CQV Engineer
with hands-on experience in
Computer System Validation (CSV)
activities specific to
equipment systems . The ideal candidate will have a strong foundation in
equipment qualification (IQ/OQ/PQ)
and a working knowledge of
21 CFR Part 11 compliance , including the development of associated deliverables such as
Admin SOPs, Backup & Restore procedures, and Design Specifications . Key Responsibilities:
Lead and/or support the
commissioning and qualification (CQV)
of GMP equipment and associated computerized systems. Review and/or author validation documentation:
User Requirements Specifications (URS), Functional Requirements (FRS), Design Specifications (DS), Traceability Matrices (RTM), IQ/OQ/PQ protocols , and
Summary Reports . Assist in ensuring
21 CFR Part 11 compliance
for equipment with electronic records and signatures. Support development and review of
Admin SOPs ,
Backup & Restore procedures ,
Audit Trail assessments , and system access controls. Participate in
design review, risk assessment (RA), and impact assessment
activities. Collaborate with cross-functional teams including QA, IT, Manufacturing, and Engineering to align validation strategies. Support deviations, CAPAs, and change controls related to equipment and CSV. Ensure all validation activities are performed in compliance with internal procedures, GAMP 5, and regulatory expectations. Salary Range: 120k-135k Bachelor’s degree in Engineering, Life Sciences, or related field. 6-8 years of experience in CQV roles within GMP-regulated environments. Familiarity with
equipment CSV principles , especially regarding
data integrity and Part 11 . Strong understanding of
GAMP 5 ,
Annex 11 , and relevant FDA guidance. Proficiency in authoring or reviewing system
Design Specs, Admin SOPs , and
validation protocols . Comfortable working with
automated systems , PLCs, HMIs, and SCADA integration. Excellent documentation practices and communication skills. Experience supporting
equipment-based systems
such as
bioreactors, chromatography skids, autoclaves, or controlled environmental units . Exposure to
CSV testing tools
or
system configuration audits . Experience working in a
project-based consulting environment
is a plus. What We Offer: Competitive Compensation: Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience. Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment. Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance. Eliquent Life Sciences is proud to be an Equal Opportunity Employer, committed to employee diversity.
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CQV Engineer
with hands-on experience in
Computer System Validation (CSV)
activities specific to
equipment systems . The ideal candidate will have a strong foundation in
equipment qualification (IQ/OQ/PQ)
and a working knowledge of
21 CFR Part 11 compliance , including the development of associated deliverables such as
Admin SOPs, Backup & Restore procedures, and Design Specifications . Key Responsibilities:
Lead and/or support the
commissioning and qualification (CQV)
of GMP equipment and associated computerized systems. Review and/or author validation documentation:
User Requirements Specifications (URS), Functional Requirements (FRS), Design Specifications (DS), Traceability Matrices (RTM), IQ/OQ/PQ protocols , and
Summary Reports . Assist in ensuring
21 CFR Part 11 compliance
for equipment with electronic records and signatures. Support development and review of
Admin SOPs ,
Backup & Restore procedures ,
Audit Trail assessments , and system access controls. Participate in
design review, risk assessment (RA), and impact assessment
activities. Collaborate with cross-functional teams including QA, IT, Manufacturing, and Engineering to align validation strategies. Support deviations, CAPAs, and change controls related to equipment and CSV. Ensure all validation activities are performed in compliance with internal procedures, GAMP 5, and regulatory expectations. Salary Range: 120k-135k Bachelor’s degree in Engineering, Life Sciences, or related field. 6-8 years of experience in CQV roles within GMP-regulated environments. Familiarity with
equipment CSV principles , especially regarding
data integrity and Part 11 . Strong understanding of
GAMP 5 ,
Annex 11 , and relevant FDA guidance. Proficiency in authoring or reviewing system
Design Specs, Admin SOPs , and
validation protocols . Comfortable working with
automated systems , PLCs, HMIs, and SCADA integration. Excellent documentation practices and communication skills. Experience supporting
equipment-based systems
such as
bioreactors, chromatography skids, autoclaves, or controlled environmental units . Exposure to
CSV testing tools
or
system configuration audits . Experience working in a
project-based consulting environment
is a plus. What We Offer: Competitive Compensation: Attractive salary and comprehensive benefits package for full-time and part-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks. Compensation is commensurate with professional experience. Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment. Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance. Eliquent Life Sciences is proud to be an Equal Opportunity Employer, committed to employee diversity.
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