Randstad Technical Writer in Cambridge, Massachusetts

Technical Writer

job details:

  • location:Cambridge, MA

  • salary:$35 - $45 per hour

  • date posted:Friday, March 9, 2018

  • job type:Contract

  • reference:24179

job description

Chat with me now! - https://flashrecruit.com/jobs/298781

Manufacturing Support - Technical Writer

Job Summary

This role is an exciting opportunity to be a critical part of a high growth organization that is radically changing the biotech industry. Currently, the client is building a state-of-the-art, LEED certified, cGMP manufacturing facility in Norwood, MA. This 200k sq. foot campus is critical as we continue to move more of our therapies into the clinic and require in-house manufacturing. The client is seeking a cGMP Manufacturing Support team member focusing on technical writing for our new site in Norwood, MA.

The individual in this role will be part of a cohesive team responsible for producing high quality mRNA-based medicines for evaluation in human clinical trials. The Manufacturing Support Technical Writing team member uses knowledge of cGMP regulations and biopharmaceutical production processes to create and revise standard operating procedures, batch records, specifications, forms and other critical documentation. They will work directly with subject matter experts to ensure content accuracy, improve efficiency and documentation practices.

Job Responsibilities

Heavy documentation, revising and creating SOPs, writing and formatting standard operating procedures and batch records, good comms, word skills, some GMP background and process development - this is budgeted to September, but there is always a chance it can be extended. How documents fit into vision of overall scheme, might be quality control or assurance documents, communicate with groups on their needs, meeting deadlines is critical, ask the right questions when you don't understand

  • Practices and promotes safe work habits and adheres to safety procedures and guidelines

  • Conducts document revisions and/or document management

  • Utilizes manufacturing process knowledge and documentation skills to identify areas of improvement or gaps within documentation and resolve issues and drive continuous improvement

  • Participates in cross functional teams to drive completion of document revisions or creation with a focus on prioritization and timelines for completion

  • Participates in cross-functional continuous improvement teams with Engineering, Validation, Quality Assurance, Quality Control, Facilities, and Manufacturing Science and Technology

  • Works independently with minimal supervision and direction

  • Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion

  • Creates and presents trending and metrics reports

Education & Qualifications

  • Years of experience range from 2-6 years, but someone more senior than that we can work with.

  • Bachelor's degree in Engineering or Life Sciences is preferred

  • High school diploma/GED or Biotech Certification with 2-4 years of experience, or Bachelor's Degree with 1-2 years of experience in biopharmaceutical operations

  • Understanding of biologics drug substance operations or a similar complex specialized environment

  • An understanding of regulatory requirements and their applications in a cGMP environment

  • Experience with electronic documentation systems for controlled documents in a cGMP environment

  • Excellent written and oral English language skills

  • Strong skills in the use of Microsoft Word including formatting Demonstrated ability to lead cross functional teams and deliver results with minimal supervision

  • Ability to manage multiple competing priorities in a fast-paced environment

  • Understanding of lean manufacturing methodologies and operational excellence


  • Medical, Dental, and Vision Insurance

  • 401K Plan with Company Match

  • Life and AD&D Insurance

Chat with me now! - https://flashrecruit.com/jobs/298781