Technical Writer II

Bend, OR

About the position

Support Manufacturing Department by leading technical transfer of products from Formulation and Process Development. Drafts and reviews Master Batch Records and contributes to manufacturing related deviation investigations.

Responsibilities

• Works with cross function project team to define product parameters and transfer processes from Formulation and Process Development to the cGMP plant.
• Authors Master Batch Records (MBRs) for all processes supported by the site, which are spray drying, secondary drying, oral solid dosage and packaging.
• Manages document approval work flows to enable a successful production schedule.
• Leads and authors Manufacturing related deviations and investigations using root cause analysis tools to determine CAPA.
• Reviews draft documents from other technical writers for cGMP compliance and technical efficiency.
• Maintains and continuously improves library of MBR templates for every unit operation.
• Reviews completed batch records and catalogs observations for future revisions.
• Learns new processes and materials that can improve site expertise and capabilities.
• Drafts & revises Standard Operating Procedures (SOPs) for the Manufacturing department.
• Trains the manufacturing team on SOPs and Batch Records.

Requirements

• Bachelor’s degree in STEM and/or 6+ years of relevant experience.
• A minimum of 6 years of cGMP pharmaceutical production or development experience required.
• A minimum of 2 years of experience crafting technical documents in a regulated cGMP environment required.
• Effective oral and written communication, as well as good collaboration and interpersonal skills.
• Extensive knowledge of cGMPs and FDA regulations.
• Experience with pharmaceutical equipment, processes, formulations and Good Documentation Practices (GDP).
• Strong math skills.
• Ability to manage client expectations in a professional manner.
• Knowledge of technical writing standards and protocols.
• Proficiency in Microsoft Office software (Word, Excel, PowerPoint).
• Must be extremely detail oriented and organized.
• Ability to progress and track multiple projects simultaneously against tight deadlines.

Nice-to-haves

• Experience in solid oral dosage forms highly preferred.
• Exposure to writing Deviation Investigations and Root Cause Analysis (RCA) techniques & implementation preferred.

Benefits

• COVID-19 Vaccination Update for U.S. & Canada Colleagues
• Equal Opportunity Employer