Regulatory Validation Specialist

5 days ago


Waltham, Massachusetts, United States Sequoia Biotech Consulting Full time

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. We are seeking a highly skilled Validation Engineer to join our team.

About Us

We provide fully integrated solutions across the development continuum, combining expertise in product development, regulatory strategy, quality, compliance, and commercial manufacturing. Our merger with Syner-G BioPharma Group has strengthened our ability to accelerate groundbreaking therapies and help clients navigate the complex life sciences landscape with greater agility and confidence.

We work across a diverse range of clients and projects, supporting many organizations through the most critical phases of the drug discovery, approval, product development, technology transfer, and commercial manufacturing process. We also equip our partners with the tools, knowledge, and expertise to streamline operations, enhance quality, and ensure compliance.

Our commitment to fostering a positive and engaging work environment for our employees has earned us numerous award-winning programs, including BioSpace's prestigious 'Best Places to Work' 2025 award. Join us in shaping the future where your talents are valued, and your contributions make a meaningful impact.

Job Description

The Validation Engineer will be responsible for driving overall quality performance and compliance throughout the organization by defining, implementing, and maintaining the validation program. Key responsibilities include:

  • Generating and executing life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment, and processes for qualification and verification.
  • Supporting validation activities for Basecamp and client Tech Transfer projects, including generation, execution, review, and closure of validation life cycle documents.
  • Writing, reviewing, and revising installation, operation, and performance qualification/verification-related documents.
  • Performing P&ID walkdowns and thermal mapping of temperature-controlled chambers, warehouses, and SIP processes.
Requirements

To be successful as a Validation Engineer, you will need:

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

We offer a comprehensive total rewards program that includes:

  • 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.

Compensation 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 job-related knowledge, skills, and experience. We are proud to be an Equal Employment Opportunity and Affirmative Action employers.



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