Validation Engineer

Sequoia Biotech; West Greenwich (RI); On-site; USD 70,000 - 110,000; Full time

Job summary

An innovative life sciences consultancy is seeking a Validation Engineer to enhance quality performance and compliance. In this pivotal role, you'll drive validation protocols across diverse projects, ensuring regulatory adherence and operational excellence. Your technical expertise will support critical phases of drug discovery and manufacturing, making a meaningful impact on human health. Join a team recognized for its commitment to fostering a positive work environment and career growth, where your contributions will shape the future of life-saving innovations.

Benefits

Career Growth Opportunities

Positive Work Environment

Financial Rewards

Leadership Development Programs

Qualifications

• 4-7 years of experience in biotech or pharmaceutical industry.
• Expertise in validation processes and regulatory compliance.

Responsibilities

• Generate and execute validation documentation for equipment and processes.
• Support validation activities and resolve regulatory observations.

Skills

Validation Expertise

FDA cGMP Knowledge

Technical Problem-Solving

Report Writing

Communication Skills

Education

Bachelor’s degree in a related life science field

Tools

DeltaV Systems

Job description

Join to apply for the Validation Engineer role at Sequoia Biotech Consulting

Company Description
Syner-G BioPharma Group and Sequoia Biotech Consulting recently merged in September 2024, uniting two industry leaders to create a new force in life sciences consulting. By combining our expertise in product development, regulatory strategy, quality and compliance, and commercial manufacturing, we are positioned to deliver fully integrated solutions across the development continuum.

We are helping to enhance human health. This merger strengthens our ability to accelerate groundbreaking therapies and help clients navigate the complex life sciences landscape with greater agility and confidence. Together, we form 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 work across a diverse range of clients and projects, supporting many organizations through the most critical phases of drug discovery, approval, product development, technology transfer, and commercial manufacturing. We also equip our partners with tools, knowledge, and expertise to streamline operations, enhance quality, and ensure compliance.

Syner-G BioPharma Group was recently honored with BioSpace's "Best Places to Work" 2025 award, for the second consecutive year, along with many other award-winning programs, making a career here truly life-enhancing. These recognitions reflect our commitment to fostering a positive and engaging work environment, emphasizing culture, career growth, development opportunities, financial rewards, leadership, and innovation.

At Syner-G and Sequoia, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

For more information, visit www.Sequoiabiotech.com/ or www.Synergbiopharma.com

Position Overview

Sequoia is seeking a Validation Engineer to assist with the development and execution of validation protocols for various 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.

Key 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 SOPs, validation/verification master plans, guidelines, execution plans, automation, engineering design, commissioning, qualification, 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 activities.
• Write procedures, investigations, protocols, reports, change controls, etc., to support Maintenance and Engineering departments.
• Perform P&ID Walkdowns and 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.
• 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).
• Manage punch lists for project closeout.
• Provide technical problem-solving and project management support, with a strong emphasis on these skills.
• Oversee startup and commissioning of equipment, including CQV and process background, and manage teams executing these tasks.
• Resolve troubleshooting issues, coordinating with vendors and automation contractors.
• Possess knowledge of validation processes to resolve problems and keep teams moving forward.

Qualifications And Requirements

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Education

• Bachelor’s degree in a related life science field.

Technical Experience

• 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 focus on computerized equipment and systems validation.
• Report writing experience for IQ, OQ, PQ, and CSV.

Knowledge, Skills, And Abilities

• Strong verbal and written communication skills, with the ability to discuss technical topics with non-technical audiences.

Additional Sections

The job description contains extensive, relevant information but could be more concise and better formatted for clarity and readability. The core responsibilities, qualifications, and company info are appropriate, but the presentation can be improved by removing redundant content, fixing formatting issues, and emphasizing key points. Therefore, the description requires refinement to enhance its effectiveness.