Job Title: Technical Writer II

Job REQ: 180731BR

Location / Division Information:

St. Louis MO / Pharma Services Biologics

How you will make an impact.

The Technical Writer position requires the coordination and writing of cGMP manufacturing batch records for clients. In addition, responsiblities are: addressing client comments and revisions to the documents, supported by subject matter experts. Additional responsibilities will include Standard Operating Procedure (SOP) updates to ensure agreement with the manufacturing batch records. You will be expected to possess a scientific background, preferably in biologics, solid organizational skills, and attention to detail.

What you will do.

• Responsible for the translation of processes from the Process Engineering and Process Development groups into batch production records to support cGMP manufacturing.
• Respond to internal and client comments and proactively work with SMEs to ensure comments are incorporated.
• Continually review existing templates of batch production records to generate products of consistent quality.
• Work with Quality Assurance, Operations teams, and Process Engineers to optimize templates as the need arises.
• Revise SOPs as needed to optimize processing and ensure alignment with current practices and processes.
• Collaborate cross-functionally to ensure the success of the processes and programs as needed
• Partner with other areas to ensure good quality and cGMP practices with process changes
• Live the Thermo Fisher Scientific 4Is values every day. Be proactive.
• Willingness to Gown In, on occasion, to manufacturing area to view processes.

How will you get here?

Education

Bachelors/BA in STEM or related field required

Experience

• 3+ years of industry experience, preferably in a cGMP environment. Experience writing SOP and/or pharmaceutical batch record documents is preferred.
• Proven success working in cross functional teams, ability to work collaboratively, and provide pro-active communication is required.
• Industry software (SAP, Documentum, SuccessFactors) skills preferred

Knowledge, Skills, Abilities

• Excellent understanding of cGMP and other regulatory requirements in the operation of cleanrooms
• Understanding of cGMP quality systems (e.g. change management) preferred
• Ability to work both independently and collaboratively.
• Ability to self-motivate, prioritize work and time.
• Organized, efficient, and results oriented
• Ability to follow-up on commitments and detail oriented.
• Expert in oral and written communication (verbal and written in English), as well as social skills.
• Computer literate with Microsoft Office tools, including report writing and graphing.

At Thermo Fisher Scientific, each one of our 90,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.