Senior Validaiton Engineer

Synerg; San Diego (CA); On-site; USD 110,000 - 160,000; Full time

Job summary

Syner-G is seeking a CQV Engineer with 7–11 years of experience to support commissioning, qualification, and validation activities for GMP-regulated facilities, utilities, equipment, and automation systems.

This role collaborates across Engineering, Construction, Automation, Operations, Quality, and project teams to ensure proper installation, testing, documentation, and release in line with requirements and timelines.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• 7–11 years of commissioning, qualification, and validation experience in GMP settings.
• Ability to review and generate CQV documentation and closeout packages.

Responsibilities

• Review design, vendor, turnover, and qualification docs for CQV execution.
• Execute IQ/OQ/PQ protocols and functional testing.

Skills

CQV experience

Commissioning

Qualification

Validation

Documentation

Cross-functional collaboration

Regulatory compliance

Education

Bachelor's degree in Engineering/Life Sciences

Tools

IQ

OQ

PQ

Job description

COMPANY DESCRIPTION:

A career here is life-enhancing.

At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here.

Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.

Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.

At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

For more information, visit www.Synergbiopharma.com

POSITION OVERVIEW:

We are seeking a CQV Engineer with 7–11 years of experience supporting commissioning, qualification, and validation activities for GMP-regulated facilities, utilities, equipment, automation systems, and manufacturing processes. This role is responsible for the execution of commissioning and qualification activities, including system walkdowns, protocol execution, documentation review, discrepancy management, and system turnover support. The CQV Engineer will work cross-functionally with Engineering, Construction, Automation, Operations, Quality, and project teams to ensure systems are installed, tested, documented, and released in accordance with approved requirements, project timelines, and regulatory expectations.

KEY RESPONSIBILITIES:

(This list is not exhaustive and may be supplemented or adjusted as needed.)

• Review approved design, vendor, turnover, and qualification documentation in preparation for commissioning and qualification execution activities.
• Support system walkdowns, field verification activities, construction completion reviews, and readiness assessments.
• Execute commissioning and qualification protocols, including IQ, OQ, PQ, functional testing, and other approved test documentation as applicable.
• Verify installation of equipment, utilities, instrumentation, controls, and automation systems against approved drawings, specifications, vendor documentation, and design requirements.
• Verify system functionality, alarms, interlocks, controls, instrumentation, and operational requirements during execution activities.
• Coordinate testing activities with Engineering, Construction, Automation, Operations, Quality Assurance, and equipment vendors to support execution schedules.
• Perform and document field testing activities and collect objective evidence required to support protocol execution and qualification deliverables.
• Identify, document, and track discrepancies, punch-list items, protocol exceptions, and deviations encountered during execution activities.
• Support investigations, issue resolution, corrective actions, retesting, and closure of execution-related deviations and discrepancies.
• Perform protocol data review and ensure documentation is complete, accurate, attributable, and compliant with GMP documentation requirements.
• Review turnover packages and verify supporting documentation required for system acceptance and qualification.
• Develop and complete qualification summary reports, turnover documentation, and system closeout packages.
• Support system release and handover activities to Operations and Quality upon successful completion of required CQV deliverables.
• Maintain execution status and communicate progress, constraints, project risks, and dependencies to CQV and project leadership teams.
• Participate in project meetings and collaborate with cross-functional stakeholders to ensure alignment with project schedules and milestones.
• Support regulatory inspections, audits, and quality initiatives as they relate to commissioning, qualification, and validation activities.

QUALIFICATIONS AND REQUIREMENTS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.

Technical Experience

• 7–11 years of commissioning,