Technical Writer Iii - Carlsbad, United States - Thermo Fisher Scientific

Mark Lane

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Mark Lane

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Description

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale.

Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer.

We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.


Location/Division Specific Information

Work Location:
Carlsbad, CA (on-site)


Group:
Life Sciences Solutions Group


Division:
Biosciences Division


How will you make an impact?


As a Technical Writer, you will be an important part of a cross-functional team tasked with aiding the site's operational team in problem-solving, process implementation, and investigative management, both independently and collaboratively.

In this role, you will provide critical support to the manufacturing operational team by addressing daily quality issues and leading various initiatives, agendas, and projects.


What will you do?

  • Develop precise and concise work instructions tailored to technical and scientific manufacturing procedures.
  • Innovate and formulate procedures that align with product specifications and uphold thorough quality standards.
  • Analyze historical production records and manufacturing documents to capture relevant data and insights into existing processes.
  • Prepare investigation and root cause analysis reports per established quality standards.
  • Develop close collaboration with manufacturing department personnel to resolve optimal document formats and identify methods, protocols, and standard methodologies to integrate into the instructions.
  • Create and maintain documents using an electronic document management system.
  • Ensure adherence to SKU data standards and supply chain prerequisites that impact SKU configuration.
  • Collaborate with team members to efficiently distribute workloads, lead project progress, and conduct thorough reviews of colleagues' work to ensure accuracy.
  • Be responsible for the design of validation documents and lead their implementation to completion.
  • Lead initiatives for the implementation of Corrective and Preventive Actions (CAPA) to rectify deviations and address customer complaints.

How will you get here?

Education

  • Bachelor's degree in Sciences or Engineering

Experience

  • 2+ years of experience developing and editing engineering documentation for production workflows and manufacturing records.
  • Confirmed experience evaluating and editing SOP's and other documentation for accuracy and comprehension
  • Proven ability to write multiple Work Instructions and Validation Reports that align with product specifications and regulatory standards
  • 3+ years of experience in a manufacturing environment or similar role
  • 2+ years of experience in an ISO or cGMPregulated manufacturing environment
  • 2+ years of experience in technical writing
  • Proficiency with ERP systems and a basic understanding of cost accounting and standard manufacturing financials
  • Familiarity with Practical Process Improvement (PPI) Systems and tools (or equivalent Continuous Improvement and Lean Systems)
  • Previous experience working with multifunctional teams on projects of varying complexity
  • Understanding of manufacturing processes and interdepartmental responsibilities

Knowledge, Skills and Abilities

  • Proficient in Microsoft Office Software, particularly Excel, Word, and PowerPoint
  • Collaboration skills and the ability to effectively influence others
  • Excellent verbal and written communication skills
  • Thrives in a fastpaced work environment
  • Consistently meticulous and precise in performing responsibilities
  • Maintains a positive demeanor towards the job and colleagues
  • Results driven and datafocused
  • Proficient in understanding manufacturing operational flows, including but not limited to Formulations, Protein Purification, Antibody Manufacturing, Filling, and Assembly/Packaging
  • Possesses robust project management skills
  • Proactively anticipates needs and identifies solutions to problems

This position has not been approved for relocation assistance.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us.

As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.

#StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

  • Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex,

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