Team Horizon is seeking a Lead Validation Engineer for our client’s manufacturing facility in the West of Ireland. In this role, you will lead a team to successfully deliver the validation programme of activities in support of manufacturing operations and coordinate the development and maintenance of the company’s validation program in compliance with all applicable regulatory and company requirements.
Why you should apply:
* Join a company that is committed to helping create healthier communities worldwide through education, outreach, and better access to treatment.
* Be part of a diverse, inclusive, and authentic workplace that offers competitive salaries, benefits, and career progression opportunities.
What you will be doing:
* Providing validation oversight and taking full ownership of the validation requalification and/or projects supporting manufacturing operations.
* Leading a team of Validation Engineers in the completion of validation activities, providing guidance and direction in the preparation and execution of validation activities, such as process validation, equipment/utilities/facilities qualification, sterilization validation, and cleaning validation.
* Acting as a key member of multi-department teams as the Validation Subject Matter Expert (SME) to bring new products/processes online or troubleshoot and/or improve existing products/processes.
* Leading validation efforts with cross-functional teams to deliver Validation projects on schedule and supporting the execution of validation/qualification studies when required.
* Contributing to areas such as regulatory submissions, change control, periodic review, investigation/deviation management, CAPAs, policy writing, and Validation Master Plans.
* Presenting validation systems at internal and external audits and supporting quality assurance programmes in conjunction with the Validation Management.
* Conducting validation activities in compliance with US and EU regulations, ISO standards, Corporate Policies, and EHS requirements.
* Supporting and developing direct reports to ensure their training and development needs are met and encouraging their continued growth within the organisation.
* Performing other duties as required.
What you need to apply:
* Minimum of a Bachelor's degree (or equivalent) in Science or Engineering and 5+ years of experience in a pharmaceutical or medical device manufacturing facility.
* Experience in people management and project management will be a distinct advantage.
* Knowledge of pharmaceutical and/or medical device regulatory requirements for FDA and IMB regulated environments.
* Supervisory responsibilities in accordance with the organization's policies and applicable laws.
* Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
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