Sr. Validation Engineer

Valspec; San Francisco (CA); Hybrid; USD 140,000 - 210,000; Full time

Benefits offered by this job

ESOP company

Premium medical coverage

401(k) with company match

Tuition reimbursement

Performance incentives

Job summary

Valspec is seeking a Senior Validation Consultant (CSV) to lead validation strategies for Emerson DeltaV DCS and GMP platforms in Northern California. You will drive CSV lifecycle activities, author critical documents, and coordinate cross-functional teams to ensure regulatory compliance and product quality.

The role emphasizes leadership, risk-based validation, data integrity, and collaboration with QA, manufacturing, and automation teams to deliver compliant validated systems on major

Qualifications

• Bachelor's degree and 10+ years of CSV experience in FDA-regulated environments
• Led validation programs for Emerson DeltaV DCS platforms
• Strong CSV lifecycle and risk-based validation knowledge
• Experience with GMP manufacturing systems and automation platforms
• Authoring/executing validation protocols and test documentation
• Understanding of GAMP 5, 21 CFR Part 11, and data integrity principles
• Experience with deviation management, CAPA and change control
• Ability to lead cross-functional teams and client-facing communications

Responsibilities

• Lead CSV activities for Emerson DeltaV DCS and GMP systems.
• Develop and execute validation strategies per FDA, GAMP 5, CFR 21 Part 11, Annex 11.
• Authors and reviews Validation Plans, VMPs, risk assessments, URS, FS, traceability, IQ/OQ, VSRs.
• Collaborate with automation and engineering teams to ensure lifecycle compliance.
• Review vendor FAT/SAT, testing records, and design deliverables.
• Lead validation execution and coordinate testing across stakeholders.
• Assess changes and support change control for validated systems.
• Support data integrity assessments and electronic records/signatures.
• Facilitate deviation investigations and remediation activities.
• Coordinate with C&Q, QA, Manufacturing and Automation teams.
• Track deliverables, schedules, milestones; report to leadership.
• Mentor junior validation engineers and contribute to planning.
• Engage in client discussions regarding validation scope and strategy.

Skills

Leadership

Regulatory knowledge

Cross-functional teamwork

Client-facing communication

Risk-based validation

Documentation rigor

GAMP 5 familiarity

Education

Bachelor's degree in Engineering, Computer Science, Life Sciences, or related technical discipline

Tools

Emerson DeltaV DCS

OSI PI

SCADA/MES familiarity

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.

Senior Validation Consultant (CSV)

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.

Key Competencies

• Technical Leadership
• Computer System Validation (CSV)
• Emerson DeltaV Expertise
• 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.

Why Join Valspec?

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
• Tuition reimbursement
• Unique performance incentives
• And more — all designed to support your growth, well-being, and future.

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.