Validation Lead
6 months ago
Team Horizon is seeking a Lead Validation Engineer Lead 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 who are 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 offer competitive salaries, benefits & career progression opportunities
What you will be doing:
You will be responsible for providing validation oversight and take full ownership of the validation requalification and/or projects supporting the manufacturing operations.
Lead 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.
Act as a key member of multi-department teams as the Validation Subject Matter Expert (SME) bringing new products/processes on-line or troubleshooting and/or improving existing products/processes.
Lead validation efforts with cross functional teams to deliver Validation projects and to schedule.
Support in execution of validation/qualification studies when required.
Contribute in areas such as regulatory submissions, change control, periodic review, investigation/deviation management, CAPA’s, policy writing and Validation Master Plan’s.
Present validation systems at internal and external audits and support quality assurance programmes in conjunction with the Validation Management.
Conduct validation activities in compliance with US and EU regulations, ISO standards, Corporate Policies and EHS requirements.
Support and develop direct reports to ensure their training and development needs are met and encourage their continued growth within the organisation.
Perform other duties when required.
What you need to apply:
Minimum of a Bachelor's degree (or equivalent) in Science or Engineering and 5+years’ experience in a pharmaceutical or medical device manufacturing facility.
Experience of people management and project management will be a distinct advantage.
Must possess knowledge of pharmaceutical and/or medical device regulatory requirement for FDA and IMB regulated environments.
Carry out 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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