Senior Validation Engineer (Cleaning Validation) Apply
XDC SG Senior Validation Engineer (Cleaning Validation) General:Lead and support all cleaning validation activities for the Singapore facilities for Drug Product and Drug SubstanceServe as SME and provide cleaning validation expertise to support the facility start-up and routine commercial manufacturing. Accountable for the timely and compliant completion of all cleaning validation related activities and milestonesPlan, manage and coordinate cleaning validation activities with internal and external resources/stakeholders Track the cleaning validation deliverables and ensure adherence to schedule for client projectsDevelop and implement cleaning validation strategies for Clean In Place (CIP) and Clean Out Of Place (COP)systems.Lead cleaning validation projects such as development and optimization of cleaning CIP cycles/recipes and / or cleaning COP cycles/recipes.Manage the process for periodic requalification of validated cleaning processes.Collaborate closely with colleagues within the Validation team and cross functional departments (QA, Manufacturing, QC).Author and review cleaning risk assessments, technical protocols and reports and supporting documentation as required.Identify requirements for laboratory studies/trials to support cleaning validation activities and to consult closely with manufacturing/QC to oversee the design and execution of studies (as required).Identify and implement improvements where feasible to cleaning processes.Lead the execution of cleaning trials and studies on the manufacturing floor.Provide on the floor support for troubleshooting cleaning related issues and lead manufacturing investigations into Cleaning Validation deviations.Will be flexible to take on additional tasks and responsibilities (other areas of validation) at the discretion of the Validation Lead. Qualification:EducationBachelor's degree or above in Engineering or Science discipline.ExperienceDemonstrated experience in cleaning validation or related validation experience in cGMP environment (5 years as a guide)Demonstrated hands-on experience in execution of cleaning validation / cleaning verification is preferred.Familiar with pharmaceutical CIP, COP and processes in drug substance and / or drug product. SkillsIn depth knowledge and experience of regulatory requirements and industry standardsExcellent verbal and written communication skills in English. Ability to read and converse in Chinese is a plus.Able to work independently with limited supervision in a fast-paced environment as well as collaborate with others in a team.Be careful, conscientious and meticulous in duties or work.Display a good working attitude, strong work ethic, and willingness to follow leadership directives.Strong collaboration, self-motivation, communication, problem-solving and technical writing skills.Demonstrated knowledge of pharmaceutical technology and processes This is a high-growth opportunity for a motivated individual in a fast-paced company. While starting as a key contributor, the successful candidate will spearhead new projects and mentor junior members.

