Sr. Validation Engineer

Valspec; Makkah Region; Hybrid; SAR 562,000 - 787,000; Full time

Benefits offered by this job

Premium medical coverage

401(k) with company match

ESOP program

Job summary

Valspec is seeking an experienced Lead Validation Consultant to support a major biopharmaceutical client in Northern California. You will lead Computer System Validation activities for Emerson DeltaV DCS and GMP platforms, serving as the technical lead for validation strategy, documentation, and compliance.

You will collaborate with automation, quality, engineering, and manufacturing teams to ensure validated systems meet regulatory expectations and support reliable GMP operations.

Qualifications

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or related technical discipline.
• 10+ years of Computer System Validation experience within FDA-regulated environments.
• Experience leading validation programs for Emerson DeltaV DCS platforms.
• Strong knowledge of the CSV lifecycle and risk-based validation methodologies.
• Experience supporting GMP manufacturing systems and automation platforms.
• Direct experience authoring and executing validation protocols and test documentation.
• Familiar with GAMP 5, 21 CFR Part 11, and data integrity principles.

Responsibilities

• Lead validation activities for CSV projects and coordinate testing across stakeholders.
• Develop and execute validation strategies adhering to FDA, GAMP 5, 21 CFR Part 11, Annex 11, and internal requirements.
• Author, review, and approve validation lifecycle documentation (URS, VMPs, IQ/OQ, etc.).
• Partner with automation and engineering teams to ensure design and lifecycle compliance.
• Review vendor FAT/SAT documents and testing records.
• Track validation deliverables, schedules, and project milestones; provide status updates.

Skills

Leadership

Cross-functional collaboration

Client-facing communication

Regulatory compliance

Risk-based validation

Validation execution

Troubleshooting

Education

Bachelor's degree in Engineering/CS/Life Sciences

Tools

Emerson DeltaV DCS

OSI PI

Rockwell

Siemens

Honeywell

Job description

Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec’s mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals.

Valspec’s projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies.

Location: Northern California (Onsite/Hybrid Based on Project Requirements)

About Valspec

Valspec is a leading provider of engineering, validation, and lifecycle services to the life sciences industry. We partner with some of the world's most innovative pharmaceutical and biotechnology companies to deliver projects that improve manufacturing performance, product quality, and patient outcomes. Our consultants work at the forefront of digital manufacturing, automation, validation, and regulatory compliance.

Position Summary

Valspec is seeking an experienced Lead Validation Consultant to support a major biopharmaceutical client in Northern California. This role will lead Computer System Validation (CSV) activities for Emerson DeltaV Distributed Control System (DCS) and associated GMP manufacturing and automation platforms.

The successful candidate will serve as the technical lead for validation strategy, documentation, execution, and compliance activities while working closely with automation, quality, engineering, and manufacturing teams. This individual will play a key role in ensuring validated systems meet regulatory expectations and support reliable GMP operations.

Responsibilities

• Lead Computer System Validation (CSV) activities for Emerson DeltaV DCS and supporting GMP systems.
• Develop and execute validation strategies in accordance with FDA, GAMP 5, 21 CFR Part 11, Annex 11, and company quality requirements.
• Author, review, and approve validation lifecycle documentation, including:
  • Validation Plans
  • Validation Master Plans (VMPs)
  • Risk Assessments
  • User Requirements Specifications (URS)
  • Functional Specifications
  • Traceability Matrices
  • IQ/OQ Protocols
  • Validation Summary Reports
• Partner with automation and engineering teams to evaluate system designs and ensure compliance throughout the system lifecycle.
• Review vendor documentation, FAT/SAT documentation, testing records, and design deliverables.
• Lead validation execution activities and coordinate testing efforts across multiple stakeholders.
• Assess system changes and support change control activities for validated systems.
• Support data integrity assessments and validation activities associated with electronic records and electronic signatures.
• Facilitate deviation investigations, impact assessments, and remediation activities related to validation deliverables.
• Collaborate with Commissioning & Qualification (C&Q), Quality Assurance, Manufacturing, and Automation teams to ensure integrated project execution.
• Track validation deliverables, schedules, and project milestones while providing status updates to project leadership.
• Mentor junior validation engineers and provide technical leadership during project execution.
• Contribute to project planning, resource forecasting, and client-facing discussions regarding validation scope and strategy.

Required Qualifications

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or related technical discipline.
• 10+ years of Computer System Validation experience within FDA-regulated pharmaceutical, biotechnology, or life sciences environments.
• Demonstrated experience leading validation programs for Emerson DeltaV DCS platforms.
• Strong knowledge of the CSV lifecycle and risk-based validation methodologies.
• Experience supporting GMP manufacturing systems and automation platforms.
• Direct experience authoring and executing validation protocols and test documentation.
• Strong understanding of:
  • GAMP 5
  • 21 CFR Part 11
  • Data Integrity principles
  • FDA and global regulatory requirements
• Experience with deviation management, CAPA, and change control processes.
• Ability to lead cross-functional teams and influence project stakeholders.
• Excellent written, verbal, and client-facing communication skills.

Preferred Qualifications

• Previous consulting experience supporting large pharmaceutical or biotechnology clients.
• Experience validating manufacturing automation systems, SCADA platforms, MES systems, historians, and integrated process controls.
• Familiarity with OSI PI, Syncade, Rockwell, Siemens, Honeywell, or related manufacturing systems.
• Experience supporting large capital projects, facility expansions, or new manufacturing sites.
• Proven ability to lead multiple validation workstreams simultaneously.
• Technical Leadership
• Computer System Validation (CSV)
• Risk-Based Validation
• Regulatory Compliance
• Client Relationship Management
• Strategic Problem Solving
• Cross-Functional Collaboration

Why Join Valspec?

At Valspec, you'll work alongside industry experts delivering high-impact projects for leading life sciences organizations. We offer challenging technical work, a collaborative culture, and opportunities to influence critical manufacturing and quality initiatives that help bring life-changing therapies to patients.

At Valspec, we offer more than just a job — we provide a career experience rooted in a standout culture, collaborative environment, and a strong sense of ownership. As an Employee Stock Ownership Plan (ESOP) company, every team member has a stake in our success, fostering a shared commitment to excellence and innovation. We also offer a highly competitive benefits package, including:

• Premium medical coverage
• 401(k) with company match
• And more — all designed to support your growth, well-being, and future.

Join a team where your contributions matter, your development is prioritized, and your success is shared.

Candidates must be legally eligible to work in the United States without company sponsorship. Also, we are not interested in working on a corp-to-corp basis with other companies at this time.

Valspec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.

The application deadline for this role is November 7, 2026