Validation Engineer

Company Description
Sequoia Biotech Consulting is a leading life sciences consultancy, dedicated to empowering organizations to overcome complex challenges and accelerate the speed to market, scale, and quality of life-saving innovations. Our multidisciplinary team of scientists, engineers, quality experts, and business professionals specializes in optimizing product development, technology transfer, and commercial manufacturing. Additionally, we equip our partners with the tools, knowledge, and expertise to streamline operations, enhance quality, and ensure compliance.
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What you will be doing :
Sequoia is seeking a Validation Engineer to assist with the development and execution of validation protocols for various types processes. The Validation Engineer will be responsible for driving overall quality performance and compliance throughout the organization by defining, implementing and maintaining the validation program.
Is this job for you?

• Generates and executes life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment and processes for (re)qualification/(re)verification.
• Supporting 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).
• Writes, reviews and revises a variety of Installation, Operation and Performance qualification/verification related documents, including any of 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.
• Writes reports to summarize validation/verification/commissioning and/or revalidation/verification/commissioning activities.
• Writes procedures, investigations, protocols, reports change controls, etc. to support the Maintenance and Engineering departments
• Performs P&ID Walkdowns. Performs Thermal mapping of temperature controlled chambers, warehouses, and SIP processes.
• Supports the resolution of regulatory observations or manufacturing site issues.
• Executing periodic reviews and requalification for temperature chambers.

Who you are:

• 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 required
• Validation expertise in Equipment, CSV, Method, and Process
• Protocol generation experience of automated production systems, with a concentration of computerized equipment and systems validation
• Report writing experience IQ, OQ, PQ, and CSV
• Strong verbal and written communication skills and ability to discuss technical topics with non-technical people is strongly desired

We Provide a Comprehensive Total Rewards Program Not Limited To:

• Excellent healthcare options: Medical, vision, prescription & dental.
• Family Focus & Balance: Parental leave, flexible time-off, and Employee Assistance Program.
• Financial Security: 401(k) with employer matching.
• Tuition Reimbursement: Continuing education for every season of your career.
• Employee Recognition Programs.

Compensation: Our compensation reflects the cost of labor across several US geographic markets. The base pay for this position ranges from $88,423.04 yearly in our lowest geographic market up to $125,935.84 yearly in our highest geographic market. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.
Legal Statement
Sequoia Biotech provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws.