Syner-G BioPharma

Syner G BioPharma Group offers leading CMC & Regulatory Affairs solutions for biopharma, specializing in strategic CMC 360 services, global regulatory affairs, and quality compliance to support successful drug development.

Professional Services

Industrials

51-250 (150)

Founded 2007

7 open positions

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Sr. Validation Engineer

21 minutes ago

United States

Full-time

Senior

QA Engineer

Quality Assurance and Testing

Apply Now

Syner-G BioPharma

Professional Services

51-250

Founded 2007

View All Jobs 7

Description

Lead the generation and execution of validation lifecycle documentation for GMP-regulated assets.
Oversee validation activities for internal and client tech transfer projects.
Author, execute, review, and close validation documents including risk assessments, plans, IQ/OQ/PQ, test methods, and reports.
Write, review, and revise qualification, verification, and commissioning documents such as SOPs, URS, FRS, design specifications, and protocols.
Prepare summary reports for validation, verification, commissioning, and requalification activities.
Develop and support procedures, investigations, 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.
Provide technical mentorship and guidance to junior validation staff while collaborating cross-functionally on timelines and operational needs.

Requirements

Bachelor’s degree in a life science, engineering, or related technical field.
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 and computerized equipment validation.
Demonstrated experience writing and reviewing IQ, OQ, PQ, and CSV reports.
Experience supporting audits, regulatory inspections, and remediation activities.
Strong verbal and written communication skills.
Highly organized with strong documentation and analytical skills.
Ability to lead validation workstreams, manage multiple priorities, work independently, and mentor junior engineers.
Experience with investigations and root-cause analysis is preferred.

Benefits

Market competitive base salary with annual incentive plan.
Expected salary range of $114,000 to $137,000 yearly.
Robust benefit offerings.
Generous flexible paid time off program.
Company-paid holidays.
Flexible working hours.
Fully remote work options for most positions.
Career development and ongoing recognition opportunities.

Interested in this position?

Apply directly on the company website

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