POSITION SUMMARY:

The Validation Lead will report to the Associate Director for Validations. The individual would be actively involved in providing support CAPEX projects for clients Cell and Gene Therapies Facility in South Boston. The lead will be responsible for providing Validation technical expertise and guidance on creation, review, and execution of qualification protocols and collaborate with Global Engineering, Facilities Operations, GIS, QA and PMO.

KEY RESPONSIBILITIES:

• Draft and implement a Site Validation Master Plan (SVMP) in line with clients procedures and policies at the start of the project.
• Author URS in collaboration with Engineering and Process Development and other applicable teams.
• Support implementation of validation strategy and approach to qualification of utilities, equipment, and the facility as defined by Validation management to meet industry regulations and standards.
• Support Project Manage all Validation tasks and ensure timely completion of Validation activities.
• Draft and review IQ, OQ and PQ protocols and execute them when required in compliance with GDP guidelines and internal quality standards.
• Provide support to non-engineering Staff, including those from R&D and Manufacturing, to ensure successful technology transfer and continuous improvement.
• Execute assigned duties on time and pro-actively telegraph delays and other issues to validation management and other relevant stakeholders.
• Comply with all regulatory, corporate, and Quality System policies.
• Completes clients assigned training and ensures that they are 100% compliant 100% of the time.
• Supports right-the-first time culture for all documents distributed across the organization.
• Performs risk assessments, if required.

IDEAL CANDIDATES:

• Receptive to change – Adapts (quickly) to changing circumstances.
• Minimum Bachelor's degree in an Engineering (Chemical, Biomedical, Industrial, Biotechnology) or related discipline with 10-12 years of relevant Validation experience or Masters in related field with 8-10 years of Validation experience.
• Self-motivated and must be able to work independently with minimal supervision and direction.
• Experience in writing procedures and developing and executing protocols in GMP industry.
• Understanding and application of technical principles, theories, and concepts in the field, CFR, Annex, GMP, ISO, GAMP, ANSI.
• Excellent technical problem solving and troubleshooting skills.

Additional Information:

42 North Solutions/ 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.