Validation Engineer

Summary

Join Syner-G BioPharma Group and Sequoia Biotech Consulting, a leading life sciences consultancy, as a Validation Engineer. You will play a key role in developing and executing validation protocols for various processes, ensuring quality performance and compliance. Responsibilities include generating life cycle documentation, supporting validation activities for projects, writing technical documents, performing walkdowns and thermal mapping, and resolving regulatory issues. The ideal candidate possesses a Bachelor's degree in a related field, 4-7 years of experience in the biotech/pharmaceutical industry, and expertise in validation processes. Syner-G offers a competitive salary, robust benefits, flexible work options, and career development opportunities.

Requirements

• Possess a Bachelor’s degree in a related life science field
• Have 4-7 years of experience within the biotech, pharmaceutical, or medical device industry
• Possess knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis
• Have validation expertise in Equipment, CSV, Method, and Process
• Have protocol generation experience of automated production systems, with a concentration on computerized equipment and systems validation
• Have report writing experience for IQ, OQ, PQ, and CSV
• Possess strong verbal and written communication skills and the ability to discuss technical topics with non-technical people

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
• Manage punch lists for project closeout
• Provide technical problem-solving and project management support, with a strong emphasis on these skills
• Oversee the startup and commissioning of equipment, including CQV and process background, and manage teams executing these tasks
• Resolve troubleshooting issues that arise, coordinating with equipment vendors and automation contractors

Preferred Qualifications

• Possess experience with DeltaV systems
• Demonstrate expertise in process equipment, with less emphasis on utilities
• Have experience in solution preparation, including working with large tanks and mixers
• Be proficient in Clean-In-Place (CIP) and Sterilize-In-Place (SIP) processes
• Have familiarity with engineering drawings and Piping and Instrumentation Diagrams (P&ID)
• Possess knowledge of validation processes to resolve problems and keep teams moving forward

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”