Tech Support Opportunities at Parexel
Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Senior Validation EngineerJob ID 51829BR Nottingham, England, United Kingdom
This role is based in our new modern state of the art office in Nottingham city centre which has excellent transport links and has a great working environment and the feel of an innovative technology company.
Would you be interested in a role where you are involved with helping bring lifesaving drugs to market? At PAREXEL, we revolutionise medicine by cutting the time this takes; the time it takes for our friends and family to get access to the drugs they need.
The primary role of the Test Lead/Senior Tester is to perform validation activities and ensure the quality of the software being developed and released. You would have oversight over and lead on major platform deliverables taking ownership of the validation strategy from conception to completion ensuring quality and safety of deliverables.
Write and execute test scripts for study level eCPS deliverables, including, but not limited to, unit/module, performance, integration, stress and capacity testing as well as participating in study level design reviews as necessary. Provide internal eCPS consulting services, where required, to the R&D, Engineering, Medical Imaging and IVRS operations departments.
- Develop and provide validation documentation activities for study level deliverables across the various platforms owned by eCPS, including, but not limited to, development and review/approval of test scripts, traceability matrices, test plans, validation summary reports, release memos and ongoing validation processes.
- Assist in the completion of associated documentation milestones including but not limited to SOPS, requirements specifications, design specification, User and Operations Manuals, Security administration processes, and network Qualifications.
- Manage multiple study deliverables, ensuring that all are completed in a timely manner and within the deadlines set, actively working with management and other internal teams to communicate any barriers or challenges,
- Execute test scripts accurately.
- Raise and manage any defects, using the appropriate software solution and follow through to resolution.
- Provide ongoing validation support and consulting on validation tasks and associated release milestones and deliverables for development and operations groups, including involvement with study level end to end and UAT, according to departmental processes.
- Ensure compliance to SOPs.
- Maintain a positive, results orientated work environment, building partnerships and modelling teamwork, communicating to the team in an open, balanced and objective manner
- Participate in formal staff review processes e.g. performance and salary reviews to corporate standards and timescales.
- Support study initiatives, including assessing the scope of validation work required, developing test strategies and providing work estimates and durations at a senior level.
- Reviewing and approving validation documentation for complex study deliverables
- Support team compliance to SOPs and departmental processes.
- Actively contribute towards existing and new processes, including development, implementation and acting as a team champion for these.
- Undertake a range of duties to support the leadership, management and development of the team where needed.
- Minimum of 5-8 years’ relevant experience within the pharmaceutical, biotechnology or biopharmaceutical industry with 2-3 years experience in leading resources and projects
- Working knowledge of cGMP guidelines, FDA 21 CFR Part 11, 210/211, EU's Annex 11 guidelines and other international regulatory requirements.
- Sound industry knowledge, project proficiency, and autonomy expected. May be considered a Subject Matter Expert (SME) in related disciplines.
- Lead and manage various validation activities and author/review related documents including validation plans, risk assessments, 21 CFR compliance assessments, qualification protocols, and summary reports.
- Lead qualification protocol execution, and manage protocol deviations investigation and corrective action activities
- Participate in user/system requirements gathering, design qualification, and CAPA investigations.
- Collaborate closely with supplier quality and system owners in defining the role of software suppliers. Assist in evaluation and oversight of supplier activities and documentation related to system qualification.
- Requires excellent analytical skills with systematic approaches to problem solving. Must be able to break down complex problems and tasks into activities capable of being performed by personnel.
- Ability to communicate effectively at all levels in verbal and written form, including technical/business writing.
- Proficient in Microsoft Word and Excel, Project and other desktop computing software.
- Able to establish and manage multiple cross-functional teams simultaneously.
- Minimum of a BS in Sciences/Engineering (other degrees accepted provided the individual has relevant experience
Apply today to begin your journey!
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