Validation Lead, GMP Equipment & CSV

BioSpace; Raleigh (NC); On-site; USD 110,000 - 150,000; Full time

Job summary

Syner‑G seeks a Sr. Validation Engineer with 7–11 years of experience to lead validation activities across equipment, utilities, facilities, and GMP-regulated processes. You will develop, execute, and manage lifecycle documentation while ensuring regulatory compliance and quality standards.

You will act as a subject matter expert, support complex technical projects, and mentor junior team members. Expect cross-functional collaboration and opportunities to drive continuous improvement in a global

Qualifications

• Bachelor’s degree in a life science, engineering, or related technical field.
• 7–11 years of experience in 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.
• Experience generating IQ/OQ/PQ and CSV reports; audits and remediation experience.

Responsibilities

• Lead validation lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, utilities, facilities, and GMP-regulated assets.
• Oversee validation activities for internal and client tech transfer projects and related validation documents.
• Write, review, and revise qualification and verification documents and test procedures.
• Prepare comprehensive summary reports for validation, verification, commissioning, and requalification activities.
• Mentor junior validation staff and provide cross-functional collaboration.

Skills

Communication

Leadership

Documentation

Problem solving

Mentoring

Education

Bachelor's degree in life science, engineering, or related

Job description

Syner‑G seeks a Sr. Validation Engineer with 7–11 years of experience to lead validation activities across equipment, utilities, facilities, and GMP-regulated processes. You will develop, execute, and manage lifecycle documentation while ensuring regulatory compliance and quality standards.

You will act as a subject matter expert, support complex technical projects, and mentor junior team members. Expect cross-functional collaboration and opportunities to drive continuous improvement in a global