Technical Writer I

Thermo Fisher Scientific - Saint Louis, MO

Full-time - Entry Level

Saint Louis, MO

Computer and Electronic Product Manufacturing

About the position

We are searching for a Technical Writer I with a good background in 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 I will use standard batch record templates and collaborate with subject matter experts to deliver high quality documents that enable Right-First-Time manufacturing. Additional responsibilities include 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. In this position, you will draft documentation, with supervision, 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. You will review documentation generated by MSAT for grammatical errors, technical style, and general readability. Additionally, you will respond to internal and client comments and proactively work with SMEs to deliver accurate documents that enable successful execution and data summary. You will partner with other areas to ensure high quality and cGMP practices are retained when revising documents for process changes. Identifying errors and participating in error proofing activities will also be part of your responsibilities. The role requires the ability to stand for long periods of time and gown into manufacturing areas to observe the manufacturing process.

Responsibilities

• Draft documentation, translating process knowledge from MSAT engineers and Process Development groups into production records, validation protocols, and technical documents for cGMP manufacturing and process validation.
• Review documentation generated by MSAT for grammatical errors, technical style, and general readability.
• Respond to internal and client comments and proactively work with SMEs to deliver accurate documents that enable successful execution and data summary.
• Partner with other areas to ensure high quality and cGMP practices are retained when revising documents for process changes.
• Identify errors and participate in error proofing activities.
• Observe manufacturing processes by standing for long periods and gowning into manufacturing areas.

Requirements

• Bachelor's degree in STEM field preferred; equivalent combinations of education, training, and relevant work experience may be considered.
• Minimum 4 years related experience in GMP regulated Biologics / Pharma Industry, or equivalent experience if no degree.
• Experience writing SOP and/or pharmaceutical batch record or validation documents is preferred.
• Demonstrates a foundation in general scientific practices, principles, and concepts.
• Shown success working in cross-functional teams, ability to work collaboratively, and provide pro-active communication.
• Knowledge of Good Manufacturing Practices and US/EU regulations.
• Follow Environmental, Health and Safety policies and procedures and ensure a safe and healthy workplace environment.
• Organized, efficient, and results-oriented with ability to work under pressure and meet tight deadlines.
• Expert in oral and written communication (verbal and written in English), as well as interpersonal skills.
• Proficient in Microsoft Office applications.