PE Global are currently recruiting for Validation Engineer III for one of our pharmaceutical clients in Cork. It is a permanent role with a competitive salary.
Responsibilities:
Specific Job Responsibilities:
Packaging Workstream
- New Product Launches
- Line to Line Product Transfers
- Packaging Projects
- Serialisation & Aggregation
- Primary & Secondary Packaging Line Qualification
- Supporting the Primary & Secondary Packaging Validation Matrix
- Operational Excellence Projects as required.
General Job Responsibilities:
- Generation, review and approval of all validation life-cycle documentation
- Generation of Product Annual Quality Reviews & System Periodic Reviews
- Deviation, change control assessment & technical support for routine manufacturing operations.
- Technical and Validation SME to support all regulatory/corporate inspections, internal audits and Regulatory Compliance Activities
- Proactive engagement in Goals/Objectives, 1:1, IDPs
- Coaching & development of junior team members.
- Participate in the governance of workstream projects, scheduling and delivery of activities in accordance with program timelines.
- Functional representative on cross-functional projects
- Supports and leads investigations of a larger magnitude.
- Articulation of technical issues and investigation outcomes to senior management.
- Executes test plans according to approved procedures, collects samples, tabulates test results, and organizes data packages.
- Compiles and analyzes validation data, prepares reports and makes recommendations for changes and/or improvements.
- May also investigate and trouble-shoot problems which occur, and determine solutions.
- Maintains master plans and SOPs pertaining to validation.
- 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.
Requirements
- Extensive understanding and application of validation principles, concepts, practices, and standards.
- Knowledge of EU-FMD, Serialisation & Aggregation- a distinct advantage.
- Proficient in current Good Manufacturing Practices (GMPs).
- Full working knowledge of equipment and systems.
- Full knowledge of industry practices.
- Strong verbal, written, and interpersonal communication skills are required.
- Investigation and report writing skills.
- Proficient in Microsoft Office applications.
- Specific Education & Experience Requirements:
- 4-5 years of relevant experience and bachelor’s degree in science or related field.
- 4+ years of relevant experience and a MS or MBA.
- 2+ years or relevant experience and a PhD.
If you are interested in this position, please forward your CV to tina.dorgan@peglobal.net or call 0214297900. Alternatively please feel free to connect with me on LinkedIn
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