CSV Engineer

Katalyst CRO; San Francisco (CA); On-site; USD 90,000 - 140,000; Full time

Job summary

Katalyst CRO in San Francisco seeks a Validation Specialist to develop and implement validation strategies for computer systems and software applications. You will create and maintain validation documentation (IQ/OQ/PQ), perform risk assessments, and collaborate with IT, QA and Operations to ensure compliant system validation.

You will conduct validation testing, review results, provide staff training, and stay current with regulatory changes. Audits and inspections participation is expected.

Qualifications

• Bachelor's degree in Computer Science, Engineering, or a related field.
• 2–5 years of experience in computer system validation.
• Strong knowledge of FDA/EMA regulatory requirements and GAMP 5.
• Experience validating ERP, LIMS, and MES systems.
• Excellent documentation and technical writing skills.
• Strong analytical and problem‑solving abilities.
• Ability to work independently and in a team.
• Excellent communication and interpersonal skills.
• Preferred: certification in Computer System Validation or related areas.
• Experience with cloud-based systems and software validation; familiarity with Blue Mountain RAM.
• 3+ years of CSV work experience; biotechnology R&D exposure is a plus.

Responsibilities

• Develop and implement validation strategies for computer systems and software applications.
• Create and maintain validation documentation, including Validation Plans, Protocols (IQ/OQ/PQ), and Validation Reports.
• Perform risk assessments to identify potential issues and ensure regulatory compliance.
• Collaborate with IT, QA, and Operations to validate systems.
• Conduct validation testing and review results to meet requirements.
• Provide training and support on validation processes and procedures.
• Stay current with industry trends and regulatory changes to sustain compliance.
• Participate in audits and inspections by regulatory agencies.
• Execute Validation Project Plans (VPPs) for GxP systems (Client, EMS, PCS).
• Support VPP execution to qualify systems for GMP equipment per SDLC and GAMP5 standards.
• Assist site Automation groups in configuring I/O and CSV protocol requirements.
• Independently perform CSV lifecycle deliverables (FRS, CS, ERES, RA, DI, IQ/OQ/PQ, Summary Report).

Skills

Validation strategies

Documentation

Regulatory compliance

Risk assessments

Cross-functional collaboration

Validation testing

Training & support

Audits & inspections

CSV lifecycle

Data integrity awareness

Education

Bachelor's degree in Computer Science, Engineering, or a related field

Tools

Blue Mountain RAM

ERP

LIMS

MES

GAMP5

Job description

• Develop and implement validation strategies for computer systems and software applications.


• Create and maintain validation documentation, including Validation Plans, Protocols (IQ/OQ/PQ), and Validation Reports.


• Perform risk assessments to identify potential issues and ensure compliance with regulatory requirements.


• Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure successful validation of systems.


• Conduct validation testing and review test results to ensure systems meet specified requirements.


• Provide training and support to staff on validation processes and procedures.


• Stay up-to-date with industry trends and regulatory changes to ensure ongoing compliance.


• Participate in audits and inspections by regulatory agencies.


• Execute Validation Project Plans (VPPs) for manufacturing GxP systems such as, Client, EMS, & PCS.


• Support the execution of VPPs to qualify systems for GMP Manufacturing Equipment in accordance with Software Development Lifecycle (SDLC) procedures as per GAMP5 industry standards


• Assist site Automation groups in configuring I/O and executing CSV protocol requirements.


• Independently perform CSV lifecycle deliverables, including but not limited to, Functional Requirements Specification (FRS), Configuration Specification (CS), Electronic Records and Electronic Signatures (ERES), Risk Assessment (RA), Data Integrity (DI) Assessment, IQ/OQ/PQ, & Summary Report

Roles & Responsibilities

• Develop and implement validation strategies for computer systems and software applications.


• Create and maintain validation documentation, including Validation Plans, Protocols (IQ/OQ/PQ), and Validation Reports.


• Perform risk assessments to identify potential issues and ensure compliance with regulatory requirements.


• Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure successful validation of systems.


• Conduct validation testing and review test results to ensure systems meet specified requirements.


• Provide training and support to staff on validation processes and procedures.


• Stay up-to-date with industry trends and regulatory changes to ensure ongoing compliance.


• Participate in audits and inspections by regulatory agencies.


• Execute Validation Project Plans (VPPs) for manufacturing GxP systems such as, Client, EMS, & PCS.


• Support the execution of VPPs to qualify systems for GMP Manufacturing Equipment in accordance with Software Development Lifecycle (SDLC) procedures as per GAMP5 industry standards


• Assist site Automation groups in configuring I/O and executing CSV protocol requirements.


• Independently perform CSV lifecycle deliverables, including but not limited to, Functional Requirements Specification (FRS), Configuration Specification (CS), Electronic Records and Electronic Signatures (ERES), Risk Assessment (RA), Data Integrity (DI) Assessment, IQ/OQ/PQ, & Summary Report

Requirements

• Bachelor's degree in Computer Science, Engineering, or a related field.


• Minimum of 2-5 years of experience in computer system validation or a related field.


• Strong knowledge of regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., GAMP 5).


• Experience with validation of various types of systems, including ERP, LIMS, and MES.


• Excellent documentation and technical writing skills.


• Strong analytical and problem-solving abilities.


• Ability to work independently and as part of a team.


• Excellent communication and interpersonal skills.


• Preferred: Certification in Computer System Validation or related areas.


• Experience with cloud-based systems and software validation, experience with Blue Mountain RAM.


• 3+ years of work experience with Computer System Validation.


• 3+ years of Biotechnology Research experience.