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Technical Writer II

Company: Thermo Fisher Scientific
Location: Bend
Posted on: August 5, 2019

Job Description:

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) scientists.
  • 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 team.
  • Performs manufacturing reviews of executed batch records and uses observations to continuously improve documents and increase efficiency.
    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 unit operation.
  • Drafts & revises Standard Operating Procedures (SOPs) for the Manufacturing group working with Manufacturing management, Process Engineers, and Quality associates to produce high quality, compliant documents.
  • Works with manufacturing management to author deviations, change controls, and other documents as needed to support ongoing operations.
  • 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 deviations.

    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 & implementation.
  • Preferred Solid Oral Dosage manufacturing and technical expertise.
  • Equivalent combinations of education, training, and relevant work experience may be considered.

    Knowledge, Skills, Abilities
  • Ability to manage client expectations in a professional manner.
  • Knowledge of technical writing standards and protocols preferred.
  • 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 typist.
  • 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.

    Physical Requirements:
    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.

    Apply today!

    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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