Engineering Technical Writer

Industry :  BioPhrmaceutical

Summary of the Role:

Engineering Technical Writer – Supports the Engineering department change management, investigation, document control & general administration activities. Authors technical documentation with the support of Project Engineers.

Essential Duties and Requirements including but not limited to:

  • Provides support, information, and assistance to individuals, groups and management with the initiation, review, submission, and follow-up of documents such as Change Controls, deviations, risk assessments, impact statements and corrective/prevention action plans.
  • Author technical evaluations, test plans & relevant lifecycle documentation.
  • Facilitates reviews of and revises department related life cycle documents, SOP’s, plans and policies for each group within the Department.
  • Identifies opportunities for continuous improvement of compliance and leads improvement initiatives.
  • Acts as a liaison between Engineering and onsite quality and regulatory groups to define and address compliance related items.
  • Provides tracking and trending for maintenance of related compliance activities i.e. quality instances
  • Participates in and obtains results of department quality and regulatory audits.
  • Specifies and coordinates training, OJT and SOP, for Automation, Engineering and contracted personnel.
  • Maintains knowledge of current good manufacturing practices (cGMPs).

Education and Experience:

  • Primary degree in Science/Engineering discipline and 3+ years of related experience working in a cGMP environment (biopharmaceutical desirable) or in the operation of an industrial facility. May substitute relevant experience in lieu of education.
  • Ability to work on own initiative, without direct supervision from management.
  • Team player with an ability to work well across various departments on site as well as business partners.
  • Excellent written, presentation, communication and investigation skills.
  • Deadline focused individual.
  • Direct experience and in-depth knowledge of biopharmaceutical equipment desirable (Solution Prep, Bioreactor, Centrifuge, Chromatography, UFDF) desirable.

Duration: 1 year full time contract – combination of remote and on-site

Location: Limerick

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