AIT Technical Writer
SimoTech requires an experienced AIT Technical Writer for a large-scale biopharmaceutical project in Dublin. Candidates must have at least 3 years’ experience in GXP regulated environment, working within the biotechnology or pharmaceutical industry.
- Reporting to the AIT Compliance Lead and working with cross functional team representing IT Infrastructure, Process Automation, MES, Laboratory Systems and Enterprise Systems
- Work closely with AIT Compliance Lead to implement site strategy and processes for AIT Procedures and Work Instructions (WI) to ensure systems have required operation and maintenance activities in place and are maintained in validated state.
- Work within the site strategy of the AIT Framework to deliver a suite of WIs to meet the twin requirements of supporting the A&IT Systems and the SOP Simplification Initiative.
- Work across all AIT functions to develop a common approach to SOPs and delivery of same
- Responsible for the assigned SOP deliverable(s) to support the defined AIT Framework
- Work with cross functional team to develop WI and understand requirements
- Create WI to align with requirements
- Ensure Procedure alignment with directives and regulatory requirements
- Support retrospective mapping effort to obsolete and reference update affected documentation related to the implementation of AIT Framework.
- To develop/modify training material with System Owners to support the SOP’s and Work Instructions.
- Bachelors Degree in Engineering, Information Systems, Computer Science or the Life Sciences.
- At least 3 years’ experience in GXP regulated environment
- Experience in the development of procedures for the management of AIT systems in the pharmaceutical environment.
- Experience of Pharmaceutical Industry Regulations (cGMP/cGLP). Knowledge of 21 CFR 11 and EU Annex 11 compliance requirements.
- Strong Technical Writing skills
- Proven success working well in a team environment
- Experience in IT Infrastructure, Process Automation, Laboratory Systems and Enterprise Systems desirable
By submitting my data (C.V.), I consent to SimoTech collecting and storing my personal data, as outlined in the SimoTech Privacy Statement which I have read.