Job Description
CSV Engineer Location:Ringaskiddy, Cork - 3 days a week on-site Duration: 12 months Hours: 39 per week Imagine your next project working as a CVS Engineer for Johnson & Johnson Innovative Medicine. Responsible for developing a process for and performing of validation of computer and/or automation systems compliance current Good Manufacturing Practices (cGMPs) and all other regulatory and/or guidance requirements such as Annex 11, GAMP and 21 CFR Part 11. Roles and Responsibilities Develop a process for the validation of computer and automation systems ensuring compliance to required regulatory requirements. Coordinates and executes training of required personnel on the computer and automation systems validation procedures and methodology. Keeps systems and processes developed for computer and automation systems validation up to date and compliant. Gives guidance on all activities related to computer and automation systems validation. Support activities include, but are not limited to, SOP creation, documentation review and approval Including change controls, assessment plans, risk assessment reports, compliance plans, user requirements, system and user acceptance testing protocols, traceability matrix, error reports/defect report forms and summary reports. Compiles and analyses validation data and makes recommendations for changes and/or improvements. May also investigate and trouble-shoot problems which occur and determine solutions. Maintains all documentation pertaining to computer systems validation. Participates on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups. Contributes directly to the completion of projects through the management of assigned contract personnel, development and execution of validation change control documents, and development and review of protocols, reports and data tables generated by peers and contract personnel. As required, prepares summaries of validation testing for regulatory submissions and presents validations to regulatory agencies. Coordinates assigned projects and represents department on project teams. Serves as an information resource for computer systems validation to validation engineers, contractors and vendors. Resolves computer systems validation issues of moderate scope with limited direct supervision. How to succeed Bachelors degree in a technical, scientific or related field is preferred. Min 6 years of related industry experience Min 3 years of experience in CSV system development life cycle is required. Validation experience with ERP, MES, LIMS, and Quality Systems is preferred. Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11 is required. Strong knowledge of system development life cycle is required. Knowledge/familiarity with U.S. and Global regulatory registration of drug products is preferred. Strong leadership skills and the ability to work in cross-functional team environments, as well as independently, and to manage multiple and competing projects are required. The ability to travel up to approx. 10% (domestic and international) is required. Benefits This role offers a very competitive hourly rate. This contract will run for 12 months and has a strong chance of extension. You are welcome here Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are. About Johnson & Johnson Innovative Medicine Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow. Our diverse portfolio spans multiple therapeutic areas Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way. Application process We are looking to process the first round of applications within the next 2 working days. We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE, LTD & Umbrella options are available. Diversity, Equity & Inclusion For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means You Belong. Skills: Strong leadership skills Thorough knowledge of cGMP regulations Validation experience with ERP, MES, LIMS