Über diese Sr. Validation Engineer Stelle bei Valspec
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.
Join a great team supporting world-class life sciences clients throughout Northern California. Apply today!
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.
Join a team where your contributions matter, your development is prioritized, and your success is shared.
When receiving e-mails from a Proconex or Valspec recruiter, you will only receive e-mails from addresses ending in @proconexdirect.com, @proconex.net or @valspec.net. Any other domains are impersonations and should be ignored.
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.
Any third-party unsolicited resume submission(s) will immediately become the property of Valspec. Valspec will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.
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.
