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Validation Engineer
Montgomeryville, PA
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A manufacturer ultrapure water systems located in Montgomeryville, PA is seeking a Documentation Engineer to join their team. This person will create, organize, manage, and maintain accurate and accessible documents to support organizational operations, validation, and knowledge sharing. Will work with subject matter experts within the Engineering and Technical Services Team to draft materials such as submittal packages, O&M manuals, technical guides, validation packages, and system specifications, to provide clarity and details to support each high purity water system design. This is a customer-facing role requiring organization, attention to detail, and technical competence in ultrapure water systems.
Job Responsibilities:
Collaborate with engineering team to author, execute, and support Validation packages for any 'won' opportunities that require validation (IQ/OQ/PQ, SAT/FAT); Execute written validation documentation for any systems that require validation at division locations and/or customer sites (Some travel required, estimated to be 10-20% and primarily in the Northeast USA); Create Submittal and O&M packages for any 'won' capital project opportunities with engineering team support; Collaborate with engineering team to generate documentation that may be required on a per job basis; Work with engineering and production teams during QC testing of large capital systems to ensure accuracy of any documentation required, system tagging, and system drawings prior to shipment; Respond in a timely manner to all team member and/or customer questions (zoom, email, phone) with engineering team's support.
Job Requirements:
Bachelor of Science degree in engineering or engineering technology preferred; Technical writing, validation specialist, or quality assurance experience preferred; Minimum of 1-3 years of experience in an engineering documentation role with a strong preference within high purity water or related industry such as pharmaceutical, biotech, medical device, or semiconductor; Preferred 1-3 years of experience with validation documentation and execution with a strong preference within the high purity water industry. #IND