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