Our client is looking for a Quality Assurance Validation Specialist to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures.Responsibilities:- Act as Quality Assurance approver for qualification/validation lifecycle documents.- Serve as a quality assurance resource for assessing validation requirements, non-conformance, impact assessments, root cause analysis.- Will serve as the Quality SME for all validation activities across the site including but not limited to Steam in Place(SIP), Cleaning Validation & CTU (Controlled temperature Unit) Performance qualification.- Provide Quality Assurance Validation support for Steam In Place (SIP) of buffer and media preparation systems, upstream (bioreactors) and downstream equipment trains & Autoclave loads.- Provide Quality Assurance Validation support for the Cleaning Validation Program. Cleaning (CIP) cycles/ for buffer and media preparation systems, upstream (bioreactors) and downstream equipment trains, parts washers and supporting process equipment.Qualifications and experience:- This role requires a minimum of 3 years experience in, Quality Assurance,Technical Operations or Engineering within the Biopharma / Pharmceutical industry. - A self-starter and results-focussed, the successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.- Experience working in regulated environment with exposure in the Regulations & guidance's - GMP, CGMP, GAMP, 21 CFR Part 11- Must have at least 3 years of experience in commissioning, qualification, and validation activities in in a regulated environment. - Technical knowledge of Cleaning validation/verification, quality systems and regulatory requirements.- Experience in review and approval of Cleaning Validation studies. - Experience in review of temperature mapping studies. Ex CTU's, Autoclaves, SIP systems.