Manufacturing Technical Writer

Celltrion Branchburg, LLC•Branchburg Township, NJ

13d•$71,250 - $116,000•Hybrid

About The Position

Celltrion Branchburg, LLC is seeking a Manufacturing Technical Writer to support the Manufacturing Process team(s) in authoring, reviewing, and approving GMP documentation. This role is crucial for the successful manufacture of commercial and clinical products in the BB50 Manufacturing Facility, playing a key part in product re-introductions and new product introductions. The position involves regular interaction with Operators, Process Engineering, TS/MS, Quality Assurance, Quality Control, and Logistics departments. A working knowledge of cGMPs, manufacturing operations, and documentation support systems like Regulus and Trackwise is essential.

Requirements

Technical proficiency of operations within an area and willingness to acquire technical proficiency in all areas of manufacturing.
Effective writing skills, demonstrated through authorship of batch records, standard operating procedures, and observations/deviations.
Team-first attitude.
Excellent organizational, communication, interpersonal, and written skills.
Ability to prioritize work, drive projects to completion, and collaborate with cross-functional groups to drive decisions supporting documentation completion.
Ability to wear appropriate clean room attire.
Ability to walk down systems when writing documents to ensure completeness.

Nice To Haves

Working knowledge of cGMPs, manufacturing operations and documentation support systems, such as Regulus and Trackwise.

Responsibilities

Ensuring production documentation, such as Process Batch Records, Standard Operating Procedures (including procedures that support the execution of Electronic Batch Records) and Forms, are accurate and available for use in a timely manner to support manufacturing operations.
Managing the Manufacturing Document Revision Tracking Spreadsheet(s) and ensuring modifications to batch records that apply to multiple products are integrated into each applicable production process.
Providing visibility of documentation review/approval schedules to the Process Team and driving the team to meet timelines.
Supporting continuous improvement efforts by streamlining batch records and standard operating procedures, as well as the review and approval process.
Owning document-related change control implementation summaries for the manufacturing department.
Authoring, reviewing, and approving technical reports.
Providing subject matter expertise and executing the routing and management of documents in the controlled quality documentation system.
Contributing to and adhering to the safety, environmental, and quality standards of the Corporation.
Providing guidance on the document revision process for the local Document Management System.
Facilitating PmatchesP exercise as needed.