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  Develop, review, and maintain manufacturing and digital documentation, including SOPs, digital work instructions, work instructions, batch records, and equipment maintenance logs.
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  Ensure documentation is current, accurate, properly controlled, and aligned with regulatory requirements, GMP/GxP standards, internal quality procedures, and approved digital workflows.
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  Support the creation and maintenance of controlled documents for product specifications, testing protocols, design history files, and digitized manufacturing processes.
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  Maintain compliance with data integrity principles such as ALCOA+ and internal quality standards, ensuring traceability between approved documents and digital execution tools.
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  Partner with Quality Assurance, Manufacturing, Engineering, and Digital Operations teams to ensure documentation and workflows meet company policies and industry regulations.
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  Assist with internal audits, document reviews, and inspection readiness activities by providing documentation support and traceability evidence aligned with regulatory and ISO standards.

Requirements

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  Bachelor’s degree in science, engineering,
  quality, or related technical field.
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  Experience in regulated manufacturing
  environments such as pharmaceutical, biotechnology, or medical devices.
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  Working knowledge of GMP/GxP requirements,
  document control practices, and data integrity principles such as ALCOA+.
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  Strong attention to detail, technical writing
  skills, and the ability to work cross-functionally with multiple departments.
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  Experience supporting digital manufacturing
  systems or electronic documentation platforms are preferred.