Senior Validation Engineer

synerg; San Diego (CA); Presencial; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

Syner-G is seeking a Sr. Validation Engineer with 7–11 years of experience to lead validation activities across equipment, utilities, facilities, and computerized systems in GMP‑regulated environments. This role develops, executes, and manages validation lifecycle documentation while ensuring regulatory compliance and quality standards.

The Sr. Validation Engineer will act as a subject matter expert, support complex projects, and mentor junior staff, collaborating with cross‑functional teams to

Formación

• 7–11 years of experience in biotech, pharmaceutical, or medical device industries.
• Strong knowledge of FDA cGMP requirements, risk-based validation, and FMEA.

Responsabilidades

• Lead validation lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, utilities, facilities, cleaning, and shipping systems.
• Oversee validation activities for internal and client tech transfer projects; author, execute, review, and close validation documents (IQ, OQ, PQ, risk assessments, validation plans).
• Write, review, and revise qualification and verification documents (SOPs, validation master plans, URS, FRS, design specs, commissioning tests).
• Prepare comprehensive summary reports for validation, verification, commissioning, and requalification activities.
• Develop and support procedures, investigations, protocols, reports, and change controls for Maintenance, Engineering, and Quality functions.
• Lead P&ID walkdowns to verify installation, configuration, and system readiness.
• Perform and oversee thermal mapping of temperature-controlled chambers, warehouses, and SIP processes.
• Support resolution of regulatory observations, audit findings, and manufacturing site issues related to validation.
• Lead periodic reviews and requalification activities for temperature-controlled systems and other validated assets.
• Provide technical mentorship and guidance to junior validation staff.
• Collaborate cross-functionally to ensure validation activities align with project timelines and operational needs.

Educación

Bachelor's degree in a life science, engineering, or related technical field

Herramientas

Computerized systems validation (CSV)

Descripción del empleo

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 Sr. Validation Engineer with 7‑11 years of experience to lead validation activities across equipment, utilities, facilities, computerized systems, and manufacturing processes within GMP‑regulated environments. This role is responsible for developing, executing, and managing validation lifecycle documentation while ensuring compliance with regulatory expectations and internal quality standards. The Sr. Validation Engineer will serve as a subject matter expert, support complex technical projects, and provide guidance to junior team members.

KEY RESPONSIBILITIES

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

• Lead the generation and execution of validation lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, utilities, facilities, cleaning processes, shipping systems, and other GMP‑regulated assets.
• Oversee validation activities for internal and client tech transfer projects, including authoring, executing, reviewing, and closing validation documents such as risk assessments, validation plans, IQ, OQ, PQ, test methods, and validation reports.
• Write, review, and revise qualification and verification documents, including SOPs, validation master plans, execution plans, URS, FRS, design specifications, FAT documentation, verification protocols, and commissioning test procedures.
• Prepare comprehensive summary reports for validation, verification, commissioning, and requalification activities.
• Develop and support procedures, investigations, protocols, reports, and change controls for Maintenance, Engineering, and Quality functions.
• Lead P&ID walkdowns to verify installation, configuration, and system readiness.
• Perform and oversee thermal mapping of temperature‑controlled chambers, warehouses, and SIP processes.
• Support resolution of regulatory observations, audit findings, and manufacturing site issues related to validation.
• Lead periodic reviews and requalification activities for temperature‑controlled systems and other validated assets.
• Provide technical mentorship and guidance to junior validation staff.
• Collaborate cross‑functionally to ensure validation activities align with project timelines and operational needs.

QUALIFICATIONS AND REQUIREMENTS

Education

Bachelor's degree in a life science, engineering, or related technical field.

Technical Experience

• 7‑11 years of experience in the biotech, pharmaceutical, or medical device industry.
• Strong knowledge of FDA cGMP requirements, FMEA, and risk‑based validation principles.
• Advanced validation expertise in equipment, computerized systems (CSV), analytical methods, and process validation.
• Extensive experience generating protocols for automated production systems, with emphasis on computerized equipment and systems validation.
• Demonstrated experience writing and reviewing IQ, OQ, PQ, and CSV reports.
• Experience supporting audits, regulatory inspections, and