This is an excellent opportunity for someone who has worked in Quality or Manufacturing who has some exposure in Validation and is looking to progress within this field to become a fully trained Validation Engineer.
To plan and execute all validation activities required to ensure compliance the client (a Clinigen Group company) with regard to regulatory and internal expectations. To provide a service to them for the validation of new and existing computerised systems / equipment / facilities / processes, providing visibility of key validation lifecycle requirements.
- To ensure the Site Validation Master Plan (SVMP) is maintained accurately throughout the validation lifecycle and Validation Plans are implemented by working with multi-disciplinary teams across site
- Author or review and approve the development and implementation of Validation Plans
- To support the introduction of new computerised systems, equipment, facilities & processes through the creation of technical documentation including, but not limited to VP, URS, IQ, OQ and PQ
- To play a key role in assessing, reviewing and approving changes that may have an impact on the validation status of the computerised systems, equipment, facilities & processes
- Provide support in achieving / maintaining compliance with EudraLex – Volume 4, ICH, EMA and GAMP guidelines throughout the validation lifecycle
- Ensuring correct operation of change control for procedures and systems where there may be an impact on their validated state
- Providing consistent validation advice and inform validation working party members on changes in compliance or other regulatory expectations relating to validation of computerised systems, equipment, facilities & processes
- Assist the Operations and IT teams with the introduction of new computerised systems or processes from a validation perspective and ensure timely planning and support to their implementation
- Support the IT department with computerised system upgrades and service releases by providing additional validation qualification / testing where required
- Hands on experience of preparing and executing validation documentation in support of the Validation Manager for equipment and facilities such as Manufacturing / Quality Control equipment and Facilities temperature mapping
- Support the creation of business cases to justify Capital Investment
- Training out of new computerised systems, equipment, facilities & processes and procedures to all required personnel
- Work in close collaboration with the development team and business users to ensure that test protocols are fit for purpose by managing and identify risks
- Assist with regulatory inspections, to provide clear explanations for validation activities, protocols, and report.
- BSc (Hons) degree or equivalent in a scientific or engineering discipline
- Good planning, organisational and time management skills along with an ability to make decisions, solve problems, negotiate, influence and communicate effectively with others
- Hands on knowledge and experience of preparing and executing validation documentation throughout the computerised systems, equipment, facilities & processes validation lifecycle.
- Experience of computerised systems such as Enterprise Resource Planning (ERP), Chromatography Data Systems (CDS), QC Sample Manager and Aseptic Compounding systems
- Well-developed verbal, written, numeric and presentation skills (Must be extremely proficient in Microsoft Excel and Microsoft Word)
- Know the Company strategy and make sure what you do on a day to day basis is in line with the strategic objectives
- Ensure the work you do is of a high quality standard and procedures and policies are followed at all times
- Engage in personal professional development and attend mandatory training
- Present the Company in a positive way at all times with internal and external clients, customers and staff.
- Comply with the Company’s HR policies and the Health and Safety policy at all times
- Work flexibly and efficiently in order to meet internal and external customer needs, whilst maintaining the highest possible professional standards
- Bring new ideas and approaches with an open mind
- Maintain confidentiality and security at all times
Please apply ASAP for immediate consideration.