VALIDATION ENGINEER-SYSTEMS INTEGRATION
Excellent opportunity to join an independent automation systems integrator, dedicated to increasing the visibility of real-time information to improve the performance of manufacturing and processing companies. We specialise in the design and implementation of the following systems and services: Management Information Systems, Process Control Systems, Regulatory Compliance Training, Project Management & Engineering Services and Vision Systems.
Must have skills. At least 5 years experience in Validation (Computer System/Process/Project/Equipment/Cleaning etc.) within the Biotech/Med Device/ Pharmaceutical (FDA/MHRA regulated industries). Strong cGMP, GAMP and GxP knowledge with knowledge of FDA 21 CFR Part 11, Annex 11 regulation. Must have strong ability to organize and manage multiple tasks in a fast-paced environment. Demonstrated understanding and hands-on experience generating and reviewing validation lifecycle documents. Strong interpersonal skills, excellent review and analytical skills. Strong commitment to customer service and satisfaction are essential. Capable of building, cultivating and maintaining strong trusting client relationships. Strong written and verbal communication skills. Self-motivated and a quick learner of business processes and technologies. A working knowledge of or hands-on experience with Pharmaceutical, Biotech and Med Device production processes. Ability to discuss technical aspects of validation and GxP testing with clients. Strong attention to detail regarding documentation is a must. Must be well organized and capable of working effectively within a multi-disciplinary team.
The successful Validation Engineer will be responsible for ensuring that all manufacturing processes, packing operations, equipment, cleaning, utilities/facilities, computer and analytical methods are fully validated to meet the expected and operational requirements and GMP regulatory requirements. Applicants must have the presence to promote the company image and ensure that this is enhanced by successful implementation of systems. This will be an interesting and varied role, and the opportunity to progress within the team will be available to the right candidate. Appropriate training will be provide where required and in line with business requirements.
There are no specialist Health & Safety issues related to this role.
Permanent (unless otherwise stated in the job title above).
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