Validation Engineer

Description

Worldwide Clinical Trials is seeking an IT System Validation Specialist to join our team in Austin, TX. The Validation Specialist will coordinate and perform processes associated with the validation and maintenance of systems used to support the business process of Worldwide and representing Worldwide at sponsor audits and regulatory inspections.Key Responsibilities Responsible for overseeing the validation of Worldwide systems. Responsible for the authoring of validation documentation. Responsible for developing validation strategies for new, proposed, or modified systems. Responsible for ensuring that systems remain in a validated state. To assist in training and mentoring staff in the technical competencies of validation and in contributing to validation projects. Responsible for the cataloguing and tracking of project specific validation documentation. Assist Worldwide business functions and management by reviewing and providing input on validation issues. To develop and implement SOPs and other procedural documents. To assist in the creation of training materials, guides and templates. To represent Worldwide in vendor audits and regulatory inspections. To develop strategies to ensure Worldwide systems remain auditready. To conduct vendor audits to support the implementation of thirdparty systems. Ensure that recommendations are addressed and applicable actions completed. To represent Worldwide in meetings with sponsors and vendors. Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily allinclusive. OTHER SKILLS AND ABILITIES Selfmotivated individual who can positively contribute to a team environment. Excellent interpersonal, verbal and written communication skills. Ability to handle and lead several highly complex projects simultaneously. Excellent ability to work independently, take initiative, and have a flexible approach with respect to work assignments and new learning opportunities. Able to adjust to new, different or changing requirements and is also able to work to tight deadlines. Be able to demonstrate particular attention to detail and possess the ability to multitask. Be able to create and deliver training materials on the subject of validation to use within Worldwide. REQUIREMENTS Experience of Microsoft Word to create documentation templates (inc. Macros). Experience of document authorship and control. At least 5 years experience of validation processes. At least 5 years experience of working within organisations employing GAMP, GxP, ISO standards. Experience of creating and maintaining training materials and delivering training. Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience. Desirable but not required Substantial relevant pharmaceutical industry, CRO, clinical or medical experience