Celltrion Branchburg, LLC is seeking a Manufacturing Technical Writer to support the Manufacturing Process teams by authoring, reviewing, and approving GMP documentation, including Process Batch Records, Standard Operating Procedures (including procedures that support the execution of Electronic Batch Records), and forms to support the manufacture of commercial and clinical products at the BB50 Manufacturing Facility. This role plays a key part in product re-introductions as well as new product introductions and will routinely interact with Operators, Process Engineering, TS/MS, Quality Assurance, Quality Control, and Logistics. A working knowledge of cGMPs, manufacturing operations, and documentation systems such as Regulus and Trackwise is essential.
Celltrion Branchburg, LLC is seeking a Manufacturing Technical Writer to support the Manufacturing Process teams by authoring, reviewing, and approving GMP documentation, including Process Batch Records, Standard Operating Procedures (including procedures that support the execution of Electronic Batch Records), and forms to support the manufacture of commercial and clinical products at the BB50 Manufacturing Facility. This role plays a key part in product re-introductions as well as new product introductions and will routinely interact with Operators, Process Engineering, TS/MS, Quality Assurance, Quality Control, and Logistics. A working knowledge of cGMPs, manufacturing operations, and documentation systems such as Regulus and Trackwise is essential.
Key responsibilities and deliverables: - Ensure production documentation is authored, reviewed, approved, released, and aligned with relevant Technology Transfer Documents in a timely manner to support manufacturing operations. - Own the Manufacturing Document Revision Tracking Spreadsheet(s) and ensure modifications to batch records apply to multiple products as each product is introduced or re-introduced. - Provide visibility of the documentation review/approval schedule and help the Process Team meet timelines. - Support continuous improvement by streamlining batch records, SOPs, and the review/approval process. - Own change control summaries for manufacturing documentation as required. - Author, review, and approve technical reports as needed. - Manage routing and control of documents within the quality documentation sys
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Key responsibilities and deliverables: - Ensure production documentation is authored, reviewed, approved, released, and aligned with relevant Technology Transfer Documents in a timely manner to support manufacturing operations. - Own the Manufacturing Document Revision Tracking Spreadsheet(s) and ensure modifications to batch records apply to multiple products as each product is introduced or re-introduced. - Provide visibility of the documentation review/approval schedule and help the Process Team meet timelines. - Support continuous improvement by streamlining batch records, SOPs, and the review/approval process. - Own change control summaries for manufacturing documentation as required. - Author, review, and approve technical reports as needed. - Manage routing and control of documents within the quality documentation sys
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