Computer Systems Engineer

Discover International; San Francisco (CA); Hybrid; USD 199,752,000 - 315,470,000; Full time

Job summary

Discover International seeks a Validation Specialist for a 12-month hybrid contract in San Francisco. You will develop validation strategies for computer systems and software, and create Validation Plans, IQ/OQ/PQ, and Validation Reports.

Collaborate with IT, QA, and Operations to validate ERP, LIMS and MES systems, perform risk assessments, and ensure regulatory compliance with FDA/EMA and GAMP5. Strong documentation and problem-solving skills required.

Qualifications

• Bachelor's degree in Computer Science, Engineering, or related field.
• Minimum 2–5 years in computer system validation or related field.
• Strong knowledge of FDA/EMA regulations 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 as part of a team.
• Excellent communication and interpersonal skills.
• Certification in Computer System Validation preferred.
• Experience with cloud-based systems and software validation.

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 ensure requirements are met.
• Provide training and support to staff on validation processes.
• Stay current with regulatory changes to ensure ongoing compliance.
• Participate in audits and inspections by regulators.
• Execute Validation Project Plans (VPPs) for GMP systems and SDLC per GAMP5.

Skills

Regulatory compliance

Validation testing

Documentation

Risk assessment

Cross-functional collaboration

Analytical skills

Communication

Independent work

Teamwork

Training staff

Education

Bachelor’s degree in Computer Science or related field

Tools

Blue Mountain RAM

Job description

12 Month Contract - Hybrid 3 days Onsite

What you’ll do:

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, BMS, 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

About you:

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.