​​​​​​The Validation Engineer will provide oversight of qualification and validation of a new cGMP manufacturing facility and related equipment.  The individual will be responsible for supporting a compliant validation program at Vedanta, including the implementation of new equipment and requalification of existing equipment per the equipment lifecycle program as well as supporting (evaluating, executing, and/or overseeing) validation activities for cleaning processes, facilities, utilities, and computer systems. 

• Generate system impact assessments, equipment risk assessments, user requirement specifications, and other engineering lifecycle documents for various equipment.
• Develop and execute Facility, Utilities, Systems, and Equipment commissioning and qualification protocols as required.
• Participate in FAT, SAT, as well as installation/operation of equipment prior to validation.
• Perform periodic reviews of qualified equipment, and develop and execute requalification protocols, as applicable.
• Support cleaning validation activities utilized in current and future processes.
• Support on-going validation projects; interact with all other departments for validation-related issues.
• Lead small to medium validation projects from inception to completion.

• Bachelor’s degree in a scientific discipline, engineering, or a related field.
• 5 years of experience in Validation, Quality Assurance, or a technical support role.
• Strong communication and technical writing skills. Prior validation experience and authoring validation documents is a must. Experience managing and writing deviations, CAPA, and change control is preferred.
• Solid understanding of relevant FDA/EMA/ICH validation requirements.
• Experience with Veeva Vault QMS or similar software is preferred.
• Strong analytical, organizational, and critical thinking skills.
• Flexibility to take on other duties as assigned.
• Ability to work in a fast-paced setting and adjust to a changing environment.

Full benefits package is offered and can be discussed during the interview process.

This position is a direct placement with our client.

US Work Authorization required

No c/c or 1099

Please attach a WORD resume to your submission

All of your information will be kept confidential according to EEO guidelines.