As a seasoned validation expert, you will serve as the subject matter expert on CSV activities for a Drug Product Facility Project. This high-profile role demands strategic leadership and oversight of the entire CSV scope, ensuring compliance with site standards and regulatory requirements.
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You will be responsible for preparing plans, protocols, reports, risk assessments, qualification and validation documentation for the digital and automation scope. Developing and implementing a practical, effective CSV strategy that ensures compliance is crucial to this position.
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A successful candidate will have at least 7+ years' experience leading the full validation lifecycle of automation and digital systems for a new facility from strategy and planning through qualification, compliance, and operational handover.
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In addition to your technical expertise, strong leadership ability, excellent interpersonal and communication skills, and robust project experience are essential for success in this role.
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Key Responsibilities:
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- Be the Subject Matter Expert (SME) for CSV activities on behalf of client.
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- Provide strategic leadership and oversight for the entire CSV (CSA) scope of the project.
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- Prepare plans, protocols, reports, risk assessments, qualification and validation documentation for the digital and automation scope on the project.
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- Develop and implement a practical, effective CSV strategy that ensures compliance with site standards and regulatory requirements.
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Qualifications:
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- Bachelor's degree in Engineering, Computer Science, Life Sciences or similar.
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- Minimum 7 years' experience working on validation.
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- Experience working with Rockwell systems FT Batch, FT View, Control Logix & Plant Pax.
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- Experience working with Werum Pas-X.
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Benefits:
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This role provides a high degree of autonomy to allow the successful candidate to reach their full potential. You will develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment.
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You will have the opportunity to work with large corporate clients on exciting capital projects, contributing to the design, build, operate and optimize critical process automation systems.
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