Engineering & Electronics
Senior Validation Engineer
PE Global is currently recruiting for a Senior Validation Engineer on behalf of our client based in Cork. This is an initial 12 month contract role.
The primary purpose of this job is to support major Manufacturing Engineering Projects.
The position is part of a team within the Engineering department that contributes to the overall business metrics. This position will provide project leadership on continuous improvement, and risk mitigation initiatives and will also include liaison with outside suppliers and other Design & Manufacturing sites to ensure all goals and targets of the manufacturing process are achieved
- Competent in process validation requirements on new manufacturing processes, equipment introductions & process changes.
- Responsible for performing process validation (OQ & PQ) by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements.
- Utilize six sigma statistical analysis and experimental design tools to characterize processes and support process validation activities
- Write, execute, and review all validation documents.
- Defines the requirements for Process Validation in alignment with approved SOPs.
- Executes test plans according to approved procedures, tabulates test results, and organizes data packages.
- Compiles and analyses data prepares reports and makes recommendations for changes and/or improvements.
- May also investigate and trouble-shoot problems which occur and determine solutions.
- Coordinates and executes validation change control and preparation of protocols and reports
- Participates on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups.
- As required, prepares summaries of validation testing for regulatory submissions, and presents validations to regulatory agencies.
- Independently applies validation principles to work assignments, reviews and approves documents and resolves problems.
- Coordinates assigned projects and represents department on project teams.
- Resolves validation issues of moderate scope with limited direct supervision.
Education and Experience:
- Degree qualified in a relevant Engineering / Science discipline, with 5+ years relevant experience in regulated industry, FDA, ISO, etc.
- Extensive understanding and application of validation principles, concepts, practices, and standards particularly in relation to Process Validation.
- Six Sigma Black Belt certified is preferred.
- Experience in Statistical analysis & experimental design is essential.
- Proficient in Minitab, MS Office and technical report writing skills
- Experience in medical device industry is preferred
- Proficient in current Good Manufacturing, Engineering, Practices etc (GxP).
- Strong written, verbal, and interpersonal communication skills are required.
***Interested candidates should send an updated CV to firstname.lastname@example.org or alternatively call 021 4297 900***