Top 81626 Risk Assessment Professional Jobs

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Senior Computer System Validation Consultant - 29816_M

BEPC Inc -
San Diego, CA

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Job Details

Full-time | Contract
$80.11 - $85.11 an hour

Benefits

Health insurance
Dental insurance
Vision insurance
Life insurance

Qualifications

Computer Science
Pharmaceutical regulatory compliance
Bachelor of Science
Engineering
FDA 21 CFR Part 11
GMP
Bachelor's degree
System validation
Team training
Quality assurance experience within pharmaceutical industry
Quality compliance management
IT
Technical training
Quality audits
Manufacturing
FDA regulations

Full Job Description

BEPC is actively looking for a Computer System Validation Consultant, in the San Diego, CA area!
Benefits include medical, dental, vision, and life insurance!

Job Title: Senior Computer System Validation Consultant (GxP)
Location: San Diego, CA (92111) - Onsite
Employment Type: 6-month Contract (W2)
Pay Rate: $80.11–$85.11/hour (paid weekly!)
Schedule: 8:00 AM–5:00 PM (with flexibility to work earlier or later as needed)

Note: This is a W2 only role — C2C, C2H will not be considered

Role Overview:

BEPC is seeking a highly motivated Senior Computer System Validation Consultant (GxP) to support our client’s Computer System Validation program in San Diego, CA. This onsite role provides Quality Assurance oversight and technical validation expertise for GxP computerized systems across laboratory, manufacturing, IT, and quality environments.

Key Responsibilities:

Author, review, and approve validation plans, risk assessments, URS, IQ/OQ/PQ protocols, traceability matrices, and validation summary reports.
Support requalification, periodic reviews, gap assessments, and risk assessments for computerized systems.
Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+, and applicable GMP requirements.
Serve as Quality Lead for cross-functional project teams.
Review lifecycle documentation, change controls, deviations, CAPAs, SOPs, and training documentation.
Support FDA, EMA, internal, and external audits.
Prepare compliance reports and drive continuous improvement initiatives.

Qualifications:

Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related field.
8+ years of Life Sciences experience focused on Computer System Validation and Quality Compliance.
Strong knowledge of FDA 21 CFR Part 11, 210/211, 820, EU Annex 11, GAMP 5, and ALCOA+.
Experience with GMP systems such as EDMS, LMS, LIMS, and MES.
Strong IT background, including networked systems and infrastructure.
Experience with Change Control, Deviations, CAPA, Document Control, and Training systems.
Excellent written and verbal communication skills.
Ability to manage multiple projects independently and collaboratively.
Ability to lift up to 20 pounds as needed.

About BEPC:

BEPC Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive. With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth.

Apply Now!

Qualified candidates are encouraged to apply by submitting an up-to-date resume that highlights how their experience aligns with this role. Please include specific examples of your CSV, GxP, validation documentation, and audit readiness experience.

USOPS

Pay: $80.11 - $85.11 per hour

Benefits:

Dental insurance
Health insurance
Life insurance
Vision insurance

Education:

Bachelor's (Required)

Experience:

Life Sciences industry: 8 years (Required)
GMP: 5 years (Required)
delivering CSV-related training materials: 5 years (Required)

Ability to Commute:

San Diego, CA 92111 (Required)

Work Location: In person

Quick Apply

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