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  • Validation Engineer

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    3 months ago

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    5 days ago

    Boston, Massachusetts, United States Trinity Consultants - Advent Engineering Full time

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    Boston, Massachusetts, United States VALIDATION ASSOCIATES LLC Full time

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    3 months ago

    Boston, United States CAI Full time

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    1 month ago

    Boston, United States AM Technical Solutions, Inc Full time

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Associate Validation Engineer

1 month ago

Boston, United States Massachusetts Maritime Academy Full time

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

Bachelors 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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