CK Group is recruiting for a Validation Engineer to join a company in the Pharmaceutical industry at their site based in Macclesfield on a contract basis for 12 months. The hourly rate on offer is between £65 - £70 per hour LTD.
The Company:Our client is a global pharmaceutical company with a major presence in the UK. Their purpose is to deliver life-changing medicines and to do this they are completely science-led and like to share this with the scientific, healthcare and business communities within the UK.
This role is located in Macclesfield which is East of Cheshire, on the River Bollin. It is close to the county borders of Greater Manchester to the north, Derbyshire to the east and Staffordshire to the south. It is a gateway to the Peak District and Cheshire Plains, and has breath-taking countryside, parks, rivers, canals, reservoirs and woodland to explore.
Execution of qualification of moist/dry heat sterilizers, including writing of protocols, data review and completions of associated reports.
Working in a team, you will plan and manage a schedule of autoclave/steriliser qualifications across two departments (18 units including autoclaves, ovens and sterilisation cycle of other process equipment). You will need to ensure that this work is completed in a timely manner whilst minimising the loss of production time You will develop the appropriate qualification programmes, execute them and complete the associated reports to meets the standards required by regulatory authorities. From the qualification data, you will define the acceptable range of parameters for routine operation of the sterilisers to provide a high degree of assurance that all loads are correctly sterilised. You will be responsible for providing expert advice on the diagnosis and correction of problems associated with sterilisation issues to maximise the efficiencies of the manufacturing operation. Working proactively, you will assist the installation and validation of new sterilisers, write validation protocols and procedures to meet increasingly more demanding regulatory standards aimed at providing higher levels of sterility assurance. You may also be required to manage the scheduled irradiation sterilisation revalidation requirements and associated activities and respond to any related radiation sterilisation issues. As a validation engineer, you will be responsible for identifying and progressing other similar Site activities (e.g. incubator and cold room temperature mapping) that could be managed by the Sterile Manufacturing Support Team in order to provide further efficiency gains for the Site. A lead role in developing and delivering education and awareness to colleagues, you identify key requirements and activities associated with effective steriliser qualification and ongoing compliance. You will proactively maintain knowledge of current best practice and developments in state-of-the-art sterilisation processes.
Must have Deep knowledge of ISO 14937, ISO 17665, EN 285, USP general chapter 1211, 1229 and 1035
- Good verbal and written communication at all levels and effective influencing skills, particularly at first line manager level and with other members of the Sterile Manufacturing Support Team.
- You must have good numeracy and literacy skills with a systematic approach to problem solving and a process engineering mind-set. Ideally you will hold a scientific/technical degree or equivalent.
- An inherent attitude to look for innovative technical solutions is essential to incorporate sterilization technology into lean manufacturing.
- High standards and attention to detail with a self-motivating and critical approach are also required.
- You will have experience of working in a GMP environment.
- Ability to understand the operation of sterilisers, the theory behind the sterilisation processes and the application of current international standards and regulatory requirements for sterile product manufacture.
Hours of work : If you are required to do shift they will be: Earlies = 6:00 - 13:45 / Lates = 13:15 - 21:00
For more information or to apply for this position, please contact Kate Edwards on 0191 3706487 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 46925 in all correspondence.