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.

For more information, visit www.sequoiabiotech.com/.

Validation Engineer

Position Overview: We are looking for a talented and detail-oriented Validation Engineer to execute and oversee validation activities within our clients' pharmaceutical manufacturing facilities. The Validation Engineer will be responsible for planning, executing, and documenting validation protocols, ensuring that equipment, processes, and systems operate efficiently, reliably, and in compliance with regulatory requirements.

Responsibilities:

Validation Planning:

• Develop validation master plans and protocols for equipment, processes, and systems used in pharmaceutical manufacturing.
• Collaborate with cross-functional teams to ensure validation activities align with project timelines and regulatory requirements.

Validation Execution:

• Execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for manufacturing equipment and processes.
• Conduct risk assessments and validation studies to identify potential issues and implement corrective and preventive actions.

Documentation and Reporting:

• Maintain accurate and detailed validation documentation, ensuring compliance with regulatory standards and internal procedures.
• Prepare validation reports summarizing findings, conclusions, and recommendations for stakeholders and regulatory submissions.

Change Control and Impact Assessment:

• Assess the impact of proposed changes to equipment, processes, or systems on validation status.
• Manage change control processes, ensuring that changes are properly evaluated, documented, and validated to maintain compliance.

Collaboration and Training:

• Collaborate with engineering, quality, and production teams to implement validation requirements for new equipment and processes.
• Provide training and guidance to staff on validation procedures, documentation practices, and regulatory compliance requirements.

Continuous Improvement:

• Stay updated on industry trends, regulatory guidelines, and best practices related to validation activities.
• Identify opportunities for process improvements and implement best practices to enhance validation efficiency and effectiveness.

Qualifications:

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, or related field.
• Experience in commissioning, qualification, and validation in a regulated industry
• Hands-on startup, commissioning, and qualification experience with one or more of the following systems: HVAC, Water-for-Injection, Autoclaves, Glasswashers, CIP, Bioreactors, Chromatography systems, Filtration systems
• Strong project management skills, including the ability to manage multiple projects simultaneously.
• Excellent problem-solving abilities and attention to detail.
• Effective communication skills and ability to work collaboratively in a team-oriented environment.

Salary Range

$69,000-$213,000 USD

Additional Information

Sequoia offers a comprehensive suite of benefits including, medical, dental, vision coverage, 401K, and company paid life-insurance.

Sequoia is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.