Aiq engineer

The Analytical Instrument Qualification (AIQ) Engineer will be responsible for the execution of Laboratory Computer System Validation activities within the AIQ framework. The successful candidate will be part of the Lab Services Team which will deliver validation elements for lab systems. He/she is expected to be self-motivated and develop an understanding of the business. Experience of working in a pharmaceutical manufacturing operation or a regulated environment is desirable Responsibilities: * Work with ELM team colleagues to deliver validation elements of Laboratory capital projects. * End to End ownership of Change Controls and their results. * Author\Review\Approve qualification documents for lab systems. * Work with site teams on generation of requirements and\or configuration of specifications and IOQ test protocols. * Execution of IOQ protocols for lab analytical instruments. * Generation of risk assessments. * Be a key SME for the AIQ process for all GMP audits The Ideal Candidate * A BSc in Engineering, Computer Science, or other technical degree * 5+ years rsquo; experience in a Computer Systems Validation role. * Excellent facilitation, problem solving, and decision-making skills. * Proven ability to analyse and define business problems, develop business cases, and identify appropriate process and technological solutions is critical. * Expert Knowledge of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals in particular Annex 11 21CFR Part 11. * Excellent written and oral communication skills and acute attention to detail. * Be a strong teammate who is results and target oriented