Contract Validation Engineer Job Cork
Hourly rate contract - Medical Device company - Process Validation Engineer in cork
- The primary purpose of this Contract Validation job in Cork is to support a major Manufacturing Engineering Project involving the start up of a new facility - Very exciting new job in Cork!
- 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 company Design & Manufacturing sites to ensure all goals and targets of the manufacturing process are achieved
Principle Accountabilities of the Validation Process Engineer include:
- Competent in validation requirements on new equipment introductions & process changes.
- Responsible for performing process validation studies by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements.
- Process Validation for the transfer of processes within the facility.
- Defines the requirements for Process Validation studies in alignment with approved SOPs.
- Executes test plans according to approved procedures, performs sampling, tabulates test results, and organizes data packages.
- Compiles and analyses validation 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 draft protocols, reports and data tables.
- 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
- Ability to manage multiple assignments or projects with sound analytical, troubleshooting, and problem solving skills.
- Excellent communication skills (written and oral).
- Problem solving skills - to assist in maintaining project progress and on design issues.
- Decision Making - required to make decisions on technical issues.
- Degree of responsibility - must be capable of taking direction and taking responsibility and ownership for systems.
- Excellent planning & organisation skills.
- Extent of confidentiality - discretion is essential in view of contact with outside parties, product development strategies, regulatory and sales information.
- Continuous Improvement Focus
- Extensive understanding and application of validation principles, concepts, practices, and standards particularly in relation to Process Validation.
- Proficient in current Good Manufacturing Practices (GMPs).
- Full knowledge of industry practices.
- Strong verbal, written, and interpersonal communication skills are required.
- Investigation and report writing skills.
- Degree qualified in a relevant Engineering / Science discipline, with 5+ years relevant experience.
- Experience in Statistical analysis is essential.
- Experience in regulated industry, FDA, ISO, etc.
- Demonstrated leadership skills and the ability to make effective decisions
For further information on this Contract Validation Engineer in Cork please contact Anna on 091730022 / email@example.com or if you want to discuss other contract engineer jobs in Ireland please get in touch!
Please Note: HERO Recruitment will not forward your details to any company without your prior approval