TECHNICAL WRITER (ENGINEERING) required by CareerWise Recruitment for our multinational BioTech client in Limerick, initial 12 month contract on offer.
The TECHNICAL WRITER (ENGINEERING) supports the Engineering department change management, investigation, document control and general admin activities. Authors technical documentation with the support of Project Engineers.
Role of this position
- Provides support, information, and assistance to individuals, groups and management with the initiation, review, submission, and follow-up of documents such as Change Controls, EOE's, NOE's, DNF's, risk assessments, impact statements and corrective/prevention action plans. Will 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 and PERs.
- Maintains knowledge of current good manufacturing practices (cGMPs).
- 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.
Please call Conor Twomey today for further information on 087-0907204 or email: email@example.com
CareerWise Recruitment (In Search of Excellence)