Job Description

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　　We are searching for a Technical Writer II with applied knowledge from significant experience in technical/scientific writing. This member of our team is responsible for crafting and updating cGMP (Current Good Manufacturing Practices) documentation that supports the manufacture of life-saving clinical and commercial drug products. The technical writer will use standard batch record templates and collaborate with subject matter experts and clients to deliver high quality documents that enable Right-First-Time manufacturing. Additional responsibilities include identifying and correcting gaps or misalignment between batch records and Standard Operating Procedure (SOP), analyzing manufacturing deviations to identify ways to improve reference documentation (i.e., batch records, SOPs, job aids), and optimizing the lay-out, organization, and content of documents. This role is encouraged to possess a scientific background, preferably in biologics, proven organizational skills, and attention to detail.

　　What will you do?

　　We will draft and review documentation translating process knowledge from the Manufacturing Science and Technology (MSAT) engineers and Process Development groups into production records, validation protocols and technical documents for cGMP manufacturing and process validation.General knowledge of processing equipment and operations.We will review documentation generated by MSAT for grammatical errors, technical style, and general readability.We will respond to internal and client comments and proactively work with SMEs to deliver accurate documents that enable successful execution and data summary.We will work with Quality Assurance, Operations teams, and MSAT team to optimize templates.We will revise SOPs as needed to optimize processing and ensure alignment with current practices and processes.We will partner with other areas to ensure high quality and cGMP practices are retained when revising documents for process changes.We will identify and lead/implement error proofing activities with supervisionAbility to stand for long periods of time and gown into manufacturing areas to observe manufacturing process.

　　How will you get here?

　　Education

　　Bachelors degree in STEM with 3+ years related experience (preferred: GMP regulated Biologics / Pharma Industry).Equivalent combinations of education, training, and relevant work experience may be considered

　　Experience

　　Experience writing SOP and/or pharmaceutical batch record or validation documents is preferredDemonstrates a foundation in general scientific practices, principles and conceptsShown success working in cross functional teams, ability to work collaboratively, and provide pro-active communicationKnowledge of Good Manufacturing Practices and US/EU regulationsFollow Environmental, Health and Safety policies and procedures and ensure a safe and healthy workplace environmentOrganized, efficient, and results oriented with ability to work under pressure and meet tight deadlinesExpert in oral and written communication (verbal and written in English), as well as interpersonal skillsProficient in Microsoft Office applications