Description
Senior CSV Automation Validation Engineer/Limerick/12 Months Contract/Up To 48 EUR Per Hr
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.
Key responsibilities/activities of the position
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.
Other Skills, Abilities and Education
Work within a team of validation engineers
Develop validation protocols for automated systems
Execute validation testing
Review PLC source code and logic to establish that automated systems will perform as required Develop and implement test plans for automated systems
Review documents prepared by other departments and contractor organisations
Report and investigate events and conditions which do not conform to Centocor expectations and requirements
Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports
Prepare reports of executed protocols for review by QA
Initiate and implement change control activities in accordance with site procedures
Education and Experience
Individual will have a degree qualification in science or engineering.
Individual will have a minimum of 5 years experience of validation activity in a project environment within the pharmaceutical or biotech industries.
Experience of working as part of a multidisciplinary team, and should be results focused with excellent communication and interpersonal skills Special Training or Certification:
Exposure to Emerson Delta V control system would be a advantage
Siemens S7 programming experience would also be an advantage
The Company
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services
If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.