Technical Writer II
Company: Thermo Fisher Scientific
Posted on: August 5, 2019
Job DescriptionJob Title: Technical Writer II
Requisition ID: 96535BR
When you re part of the team at Thermo Fisher Scientific, you ll do
important work, like helping customers in finding cures for cancer,
protecting the environment or making sure our food is safe. Your
work will have real-world impact, and you ll be supported in
achieving your career goals.
Location/Division Specific Information
Pharma Services Group - Drug Product
How will you make an impact?
- Creates final, perfected Master Batch Records (MBR) suitable
for use in manufacturing from drafts or development reports
prepared by Formulation & Process Development (FPD)
- Unit Operations for MBRs include: tablet compression,
encapsulation, blend/mill/blend, granulation, pan-coating, hot melt
extrusion, spray drying, secondary drying, etc. Authors, edits, and
obtains approvals for documents generated for the manufacturing
group, including but not limited to; Standard Operating Procedures
(SOPs), deviations, investigations, Corrective and Preventive
Actions (CAPA), change controls and risk assessments.
- Deliver MBR, SOP and CAPA related trainings to manufacturing
- Performs manufacturing reviews of executed batch records and
uses observations to continuously improve documents and increase
What will you do?
- Authors & manages approval process for MBR.
- Authors & manages approval process for Investigations and
Deviations. Maintains and continuously improves library of MBR
templates for every unit operation.
- Drafts all packaging records from specifications for each
packaging configuration. Reviews executed batch records for Good
Manufacturing Practices (GMP) compliance (good documentation
practices, compliance to quality ALCOA principles Attributable,
Legible, Contemporaneous, Original, & Accurate) and catalogs
problems observed for future revisions to base templates for each
- Drafts & revises Standard Operating Procedures (SOPs) for the
Manufacturing group working with Manufacturing management, Process
Engineers, and Quality associates to produce high quality,
- Works with manufacturing management to author deviations,
change controls, and other documents as needed to support ongoing
- Provides clear and high quality technical rationale for actions
to be taken.
- Takes responsibility for overall management of manufacturing
documents including revisions, approval routing and timely status
reporting to manufacturing and quality management.
- Works with manufacturing operators to observe unit operations
in practice and uses knowledge gained to make master documents more
user friendly and reduce opportunities for errors or
How will you get here?
- Bachelor s degree in physical science or engineering preferred.
related and/or applicable field.
- 2 years of experience creating technical documents in an
environment governed by document standards or protocols such as
pharmaceutical, device, academia, healthcare or related field.
- Experience using Root Cause Analysis (RCA) techniques &
- Preferred Solid Oral Dosage manufacturing and technical
- Equivalent combinations of education, training, and relevant
work experience may be considered.
Knowledge, Skills, Abilities
- Ability to manage client expectations in a professional
- Knowledge of technical writing standards and protocols
- Familiarity with GMP, International Organization for
Standardization (ISO) or equivalent standards a plus.
- Familiarity with pharmaceutical equipment, processes,
formulations and Good Documentation Practices (GDP).
- Must be proficient with Microsoft Word and an expert/fast
- Skill with other Microsoft programs such as Excel, Visio,
PowerPoint also valuable.
- Must be extremely detail oriented and organized.
- Ability to progress and track multiple projects simultaneously
against tight deadlines is important for success.
- Effective oral and written communication, as well as good
collaboration and interpersonal skills.
Position requires ordinary ambulatory skills and physical
coordination sufficient to move about office and manufacturing
locations; ability to stand, walk, stoop, kneel, crouch
periodically for prolonged periods of time; manipulation (lift,
carry, move) of light to medium weights of 10-35 pound pounds; arm,
hand and finger dexterity, including ability to grasp and type for
prolonged periods of time; visual acuity to use a keyboard,
computer monitor, operate equipment, and read materials for
prolonged periods of time; ability to sit, reach with hands and
arms, talk, and hear for prolonged periods of time.
At Thermo Fisher Scientific, each one of our 70,000 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.
If you are an individual with a disability who requires reasonable
accommodation to complete any part of our application process, for
further assistance. 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. Associated topics: content, document,
documentation specialist, excel, file, log, msword, technical
writer, technical writing, writer Associated topics: content,
document, documentation specialist, excel, file, log, msword,
technical writer, technical writing, writer
Keywords: Thermo Fisher Scientific, Bend , Technical Writer II, Engineering , Bend, Oregon
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