Position located in Andover, MA

Responsibilities of the Validation Engineer:

• Will be responsible for providing quality and technical support for qualification and validation activities related to analytical methods.
• Will support and facilitate the development of project plans, qualification protocols and reports for all stages of the qualification process.
• Provide quality oversight for transfer of analytical methods.
• Provide quality oversight for method verification/qualification/validation protocol, exception, and report reviews.
• Adhere to regulatory guidance, policies, and procedures for qualification and validation of analytical methods.
• Independently coordinate and directly interface with multiple departments both internally and with our contract manufacturing and testing organizations.
• Use risk management principles for qualification and remediation efforts.
• Provide regular updates directly to Management.

Requirements of the Validation Engineer:

• B.S. (or equivalent 4-year degree) in Engineering or Science Related Field.
• Minimum of 5 years validation experience supporting pharmaceutical cGMP manufacturing and/or technical support operations.
• Direct experience in analytical method qualification and validation using FDA, USP and ICH guidance required.
• Experience with method development, qualification and/or validation for clinical and commercial in-process and release testing required.