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

Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert.