Validation Engineer

Summary

Join Syner-G BioPharma Group and Sequoia Biotech Consulting, a leading life sciences consultancy, as a Validation Engineer. You will contribute to the development and execution of validation protocols for various processes, ensuring quality performance and compliance. Responsibilities include generating and executing life cycle documentation, supporting validation activities for projects, writing technical documents, and performing P&ID walkdowns and thermal mapping. The ideal candidate possesses a Bachelor's degree in a related life science field, 4-7 years of experience in the biotech/pharmaceutical industry, and expertise in FDA cGMP, FMEA, and Risk Analysis. Competitive compensation, a robust benefits package, flexible work arrangements, and career development opportunities are offered. Syner-G BioPharma Group was recently honored with BioSpace's prestigious "Best Places to Work" 2025 award.

Requirements

• Bachelor’s degree in a related life science field
• 4-7 years of experience within the biotech, pharmaceutical, or medical device industry
• Knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis
• Validation expertise in Equipment, CSV, Method, and Process
• Protocol generation experience of automated production systems, with a concentration on computerized equipment and systems validation
• Report writing experience for IQ, OQ, PQ, and CSV

Responsibilities

• Generate and execute life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment, and processes for (re)qualification/(re)verification
• Support validation activities for Basecamp and client Tech Transfer projects, including generation, execution, review, and closure of validation life cycle documents (RA, VP, IQ, OQ, PQ, TM, VR)
• Write, review, and revise a variety of Installation, Operation, and Performance qualification/verification related documents, including any or all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures
• Write reports to summarize validation/verification/commissioning and/or revalidation/verification/commissioning activities
• Write procedures, investigations, protocols, reports, change controls, etc., to support the Maintenance and Engineering departments
• Perform P&ID Walkdowns. Perform Thermal mapping of temperature-controlled chambers, warehouses, and SIP processes
• Support the resolution of regulatory observations or manufacturing site issues
• Execute periodic reviews and requalification for temperature chambers

Preferred Qualifications

Strong verbal and written communication skills and the ability to discuss technical topics with non-technical people

Benefits

• Market competitive base salary and annual incentive plan
• Robust benefit offerings
• Ongoing recognition and career development opportunities
• Generous flexible paid time off program
• Company paid holidays
• Flexible working hours
• Fully remote work options for most positions and the ability to work “almost anywhere”