Technical Writer, Pharma, Engineering GMP Operations, Packaging Line Equipment Design Standard

100% Remote

• Develop master document packages for packaging equipment assets, consisting of requirements, traceability matrix, various design specifications, maintenance packages and SOPs. These will all be based on existing documents, but need refinement and alignment from various technical SMEs.
• Assist personnel in creation and revisions to documents (e.g., standards, best practices, guidance documents, procedures, job aids, equipment design and test packages) to ensure compliance to global programs, templates, monitor redlines, incorporate feedback, confirm/update references and resources.
• Act as SME for Veeva QualityDocs (training will be provided as necessary) and provide support for document submissions and approvals.
• Act as SME for Trackwise (training will be provided as necessary) and provide support to write investigations or change controls.
• Act as SME for Kneat (training will be provided as necessary) to help team members with developing job aids, SOPs and Kneat templates.
• Facilitate select meetings including agenda callouts, capturing minutes, and tracking action items
• Assist in managing the Teams Channel and associated SharePoint sites for the above listed teams

• Bachelor's degree in Engineering or related
• 7+ years' GMP Technical Writing experience in Life Sciences
• Packaging line equipment design experience
• C&Q (commissioning, qualification) engineering experience a plus
• TrackWise, Veeva experience preferred