AIT Procedural Lead
SimoTech requires an experienced AIT Procedural Lead for a large-scale biopharmaceutical project in Dublin. Candidates must have at least 5 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 to implement site strategy and processes for AIT Procedures and Work Instructions to ensure systems have required operation and maintenance activities in place and are maintained in validated state.
- 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.
- Lead workshops with cross functional team to develop SOP and understand requirements.
- Create SOP to align with requirements.
- Ensure Procedure alignment with directives and regulatory requirements.
- Support retrospective mapping effort to obsolete and reference update impacted SOPs as a result of implementation of AIT Framework.
- Bachelors or Master’s Degree in Engineering, Information Systems, Computer Science or the Life Sciences.
- At least 5 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.
Only Candidates eligible for work permits for Ireland/EU can be considered for this role.