CQV Engineer - BlueChip Pharma - Ireland, Dublin - 9 Months

Meet Recruitment Ltd
United Kingdom
?50 per hour
04 Oct 2017
07 Nov 2017
Contract Type
Full Time
This multinational Bio-pharmaceutical company is looking for an experienced CQV Engineer to come in and deliver a high performance on this 9 month project. This full-time role is based at their manufacturing site in Dublin. This is a fantastic opportunity to get on board with a company that has a global presence in the industry and has a reputation as being a great company to work for. Company Background This company manufacture highly specialised aseptic bio-pharmaceutical products for the international market. Their products treat a wide range of therapy areas including oncology, pain management and endocrinology. Role Responsibilities Working as a CQV Engineer at this Bio-pharmaceutical manufacturing site your main responsibilities will be: - Full qualification and validation of on-site utilities and equipment in a pharmaceutical manufacturing environment including autoclaves and thermal mapping. - Working with the Engineering Director to review and update the Validation Master Plan. - Hands on writing and executing of FAT, SAT, DQ, IQ, OQ protocols of equipment and utilities. - Analysis and validation of third-party protocols and processes. This includes performing gap analysis and risk assessments of documentation procedures. - Work closely with other departments including the QA Manager to assess issues within the QMS. - Preparation of protocols, progress and final reports on all validation project. - Preparation and implementation of appropriate project control charts. This role is ideal for a CQV Engineer contractor that has experience working with a wide range of manufacturing equipment and facilities and is knowledgeable of overall GMP QA requirements to allow them to liaise with the Quality Manager when required. Skills Required - Bachelor's degree in science, pharmacy, biological science or engineering field is preferred. - Hands-on international validation experience in pharmaceutical/ biotech industry. - Wide range of qualification experience across different equipment and utility types. - Experience and the ability to carry out full IQ, DQ, CQ, OQ, and PQ. - Packaging and cold chain validation experience is preferred. - Excellent verbal and written communication skills, ability to work well in teams or independently and the ability to prioritise work and manage multiple projects while maintaining quality and compliance. Commutable Locations: Ireland, Dublin. Rate: Competitive
This job was originally posted as www.jobsite.co.uk/job/959253407