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Associate Validation Engineer

Boston, MA, United States

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

Responsibilities

Perform equipment qualifications including Commissioning, IQ, OQ and PQ

Travel both locally and internationally to help serve various clients

Write, review, approve, and execute validation protocols

Create reports summarizing results and statistics

Develop and communicate expectations for quality performance, continuous improvement, and quality systems

Assist developers and domain experts in designing, performing, and improving verification tests

Ensure validation program meets GMP, FDA, and ISO regulations

Work with scientists, technicians, engineers, and project management to deliver validated equipment and facilities

Interact with cross-disciplinary teams in order to meet project milestones and end goals

Collaborate with key stakeholders and client teams to help define needs and achievable solutions and/or justifications for equipment requirements and related validation

Experience with thermal mapping, assisting or self performing periodic reviews.

Qualifications

Bachelor’s degree in a related life science field

1-3 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 concentration of computerized equipment and systems validation

Report writing experience IQ, OQ, PQ, and CSV

Strong verbal and written communication skills and ability to discuss technical topics with non-technical people is strongly desired

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