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Job ID: JOB-12474
Senior Validation Engineer – Co Clare

My client in Clare is seeking an experienced Senior Validation Engineer to come on board.

Key Responsibilities:

Develop and maintain site master validation plan, procedures, work instructions and templates in line with corporate and regulatory requirements for validation of processes, equipment, equipment software, test methods and utilities Plan and develop annual site validation project schedule with different business centre managers and ensure validation project objectives and resources are agreed, and drive the achievement of this schedule through continuous monitoring of schedule progress, effective risk and issue management and prioritization of validation activities in line with the project schedules and plant priorities.

Lead, integrate & project manage validation tasks and develop strategies on all validation projects with multifunctional project teams ensuring project objectives are clear and understood, and can be completed as effectively as possible, on-time and compliant to company and regulatory quality and validation standards.

Provide guidance and support to all departments to ensure they understand and comply with the requirements of cGMP as applied to the validation program set down by company procedures, work instructions and guidelines.

Prepare, review and execute site validation protocols (equipment, utilities, processes, cleaning, test methods and software) and final reports ensuring compliance to all relevant corporate and regulatory quality and validation procedures/work instructions and standards

Participate in the preparation of user requirement specifications to ensure that they comply with Validation and GMP requirements as required

Execute/co-ordinate re-validation/qualification activities as required

Direct and support activities of validation engineers and provide development feedback and opportunities to assist in their daily activities.

Review/Approve change controls and assess impact of changes that affect validated systems and define validation requirements

Represent validation at both internal and external audits.

Maintain on-going understanding and knowledge of the latest regulatory requirements for validation in compliance with EU/U.S. regulations and guidance documents

Provide technical expertise during investigations, gap analysis, risk assessment and change control process.

Participate in and support the DBS improvement initiatives and tools including Kaisen events, PSP efforts, Visual Daily Management and Visual Project Mapping

Co-ordinate/supervise contractor activities as required.

Administer validation files and ensure that Validation Logging System is maintained, tracking Validations, Validation Files and ensuring accessibility when required. Organize / provide validation related training for site personnel as appropriate

Qualifications:

Bachelor’s degree in field with 5+ years exp. Validation or Quality related field OR

Master’s degree in field with 3+ years exp. Validation or Quality related field OR

Doctoral degree in field with 0-2 years exp. Validation or Quality related field

For further information on this role please contact Anna McGowan on 086 4667369 /anna@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Anna McGowan

JOB-12474

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