CSV Project Lead
The role will be based at our offices in Send, Woking, Surrey but will require travel to various locations in the UK and possibly Europe in the future.
Scitech is an award winning company operating in the UK and Belgium specialising in Pharmaceutical and life science sectors, with a broad customer base including large corporate clients. The business covers design construction, which includes plant and process equipment. In addition to this the company also provides GMP quality management and validation activities.
Relevant degree/professional qualification or equivalent experience.
5 years’ related industry experience of which 3 years’ (preferred) of system life cycle development and testing, BMS / EMS, Packaging & Labelling systems, Laboratory systems, ERP / MRP, Warehouse & Distribution systems & Process control systems.
Key Skills and Competencies:
- Strong leadership skills and communication skills with the ability of working independently or team multi-tasking as required by client projects
- Expert support and oversight for planning, scheduling and co-ordination of CSV activities
- Familiar with validation change control process
Knowledge / familiarity of EU & US GxP regulations in relation to CSV in one or more of the following:
- IT & Automation systems for Enterprise applications – ERP, Warehouse Management, Document Management
- IT & Automation systems for Manufacturing applications – PLC, DCS, SCADA , MES
- IT & Automation systems for Laboratory applications – Analytical equipment, LIMS, PAT
- PC or server based applications
- Risk assessments
- Qualification document writing and testing: URS, RTM, Design Specifications, DQ, FAT, SAT, IQ, OQ, PQ and Reports
- Give guidance on CSV and IT/ Automation systems
- Represent the company as a CSV ‘expert’ and participate in relevant presentations e.g. GAMP
- Working at client sites required, mainly in the UK but overseas travel may be necessary.
The selection process will be as follows
- Review of CV and qualification
- Telephone intervie
- Personal interview at our office in Send with directors
To apply for this position or request more information, please email your CV to [email protected] with contact details and availability. Please do not respond if you are representing a recruitment agency.
Note: The UK Government requires individuals from countries outside the European Economic Area (EEA) to be in possession of a valid work permit to allow them to take up employment (for more information please visit the Government’s website http://www.ukba.homeoffice.gov.uk/workingintheuk ). Scitech Engineering do not provide sponsorship for visa applications, facilitate work permits or enable UK entry work visas for any role advertised. All applicants must hold a valid permit to work in the region required by the role, prior to application, in order to be considered.