Manufacturing Technical Writer

Brand Description

The Manufacturing Technical Writer supports the Manufacturing Process team in authoring, reviewing, and approving of 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 in the BB50 Manufacturing Facility.

Key Objectives/Deliverables

• Manage for Results / Strategic Planning:
  • Ensure production documentation is accurate and available for use, authored, reviewed, approved, and released in a timely manner to support manufacturing operations.
  • Facilitate PmatchesP exercise as needed.
  • Own the Manufacturing Document Revision Tracking Spreadsheet(s) and ensure modifications to batch records that apply to multiple products are integrated into each applicable production process as each product is introduced/re-introduced into the facility.
  • Provide visibility of documentation review/approval schedule to Process Team and drive Process Team to meet documentation review/approval timelines.
  • Support continuous improvement efforts both from a quality and efficiency perspective by streamlining batch records and standard operating procedures as well as review and approval process.
  • Own document related change control implementation summaries for manufacturing department as required.
  • Author, review and approve technical reports as required.
  • Subject matter expertise and execution of routing and managing documents in the controlled quality documentation system.
  • Contribute and adhere to safety, environmental, quality standards of the Corporation.
  • Provide guidance on the document revision process for the local Document Management System.

Basic Requirements

• Must have a technical proficiency of operations within an area and be willing to acquire technical proficiency of operations within all areas of manufacturing.
• Must be able to write effectively as demonstrated through authorship of batch records, standard operating procedures, and observations / deviations.
• Must exhibit a team first attitude.
• Must possess excellent organizational, communication, interpersonal, and written skills.
• Must be able to prioritize work, drive projects to completion and collaborate with cross functional groups to drive decisions to support documentation completion.
• Must meet the physical requirements of the job; must have the ability to: a. Wear appropriate clean room attire. b. Walk down systems when writing documents to ensure completeness.

Pay

The anticipated compensation for this role is $71,250 - $116,000. This is a banded role, and candidates will be placed within the range based on experience, skills, internal equity, and market considerations.

Benefits

• Paid time off (holidays, vacation, and additional leave)
• Medical, dental, and vision insurance
• Life insurance
• A company-matched retirement savings plan
• Wellness programs
• Short- and long-term disability benefits

Schedule

This role requires up to 10% travel, on-call availability, and may involve shift work. Hybrid work flexibility may be available based on business needs.

Qualifications

This role is exempt.