Are you an experienced validation professional looking for a new challenge? Ipsen is excited to offer a permanent, hybrid working opportunity for a
Senior Validation Specialist
at our Wrexham site. In this role, you’ll have the flexibility to work both onsite and remotely, engaging in a variety of projects within aseptic and non-aseptic environments.
As the successful candidate, you’ll play a crucial role in driving the validation strategies that support the growth of our site and Ipsen’s innovative pipeline. This dynamic position offers the chance to work on exciting projects, ensuring compliance and excellence across our operations. We welcome individuals from diverse validation backgrounds to bring their unique expertise to our team.
At Ipsen, we are committed to fostering a collaborative and forward-thinking environment where your professional growth is supported. If you are passionate about validation and eager to make a significant impact, we would love to hear from you!
Apply now to join Ipsen and be part of a team dedicated to excellence and innovation.
Key Responsibilities
Validation Maintenance: Establish and maintain the validated status of site facilities, utilities, equipment, and processes in line with internal procedures and regulatory standards. Strategic Execution: Define and implement validation strategies for site projects, ensuring alignment with project timelines and customer expectations. Requalification Activities: Develop and execute testing strategies for requalification and revalidation activities, driving an integrated approach to commissioning and qualification. Subject Matter Expertise: Serve as a subject matter expert in specific validation areas, contributing to qualification and process improvement projects. Continuous Process Verification: Establish and manage the Continuous Process Verification (CPV) process, collaborating with the Process S&T Team and Quality function. Regulatory Compliance: Monitor regulatory trends, present validation packages during audits, and respond to audit observations. Risk Management: Utilize quality risk management principles to identify and document risks, ensuring a risk-based validation lifecycle. Leadership and Mentorship: Lead investigations, resolve nonconformance issues, and mentor junior team members to enhance departmental expertise. Documentation and Improvement: Generate, review, and approve technical documentation, and lead continuous improvement initiatives. Essential Requirements
Degree in Scientific, Pharmaceutical, or Engineering discipline or equivalent in experience. Proven experience in a qualification/validation role. Strong understanding of regulatory requirements and industry standards. Desired
Experience in biopharmaceutical or aseptic manufacturing environments. Familiarity with sterile manufacturing, lyophilisation, isolator technology, and biologics process development.
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Senior Validation Specialist
at our Wrexham site. In this role, you’ll have the flexibility to work both onsite and remotely, engaging in a variety of projects within aseptic and non-aseptic environments.
As the successful candidate, you’ll play a crucial role in driving the validation strategies that support the growth of our site and Ipsen’s innovative pipeline. This dynamic position offers the chance to work on exciting projects, ensuring compliance and excellence across our operations. We welcome individuals from diverse validation backgrounds to bring their unique expertise to our team.
At Ipsen, we are committed to fostering a collaborative and forward-thinking environment where your professional growth is supported. If you are passionate about validation and eager to make a significant impact, we would love to hear from you!
Apply now to join Ipsen and be part of a team dedicated to excellence and innovation.
Key Responsibilities
Validation Maintenance: Establish and maintain the validated status of site facilities, utilities, equipment, and processes in line with internal procedures and regulatory standards. Strategic Execution: Define and implement validation strategies for site projects, ensuring alignment with project timelines and customer expectations. Requalification Activities: Develop and execute testing strategies for requalification and revalidation activities, driving an integrated approach to commissioning and qualification. Subject Matter Expertise: Serve as a subject matter expert in specific validation areas, contributing to qualification and process improvement projects. Continuous Process Verification: Establish and manage the Continuous Process Verification (CPV) process, collaborating with the Process S&T Team and Quality function. Regulatory Compliance: Monitor regulatory trends, present validation packages during audits, and respond to audit observations. Risk Management: Utilize quality risk management principles to identify and document risks, ensuring a risk-based validation lifecycle. Leadership and Mentorship: Lead investigations, resolve nonconformance issues, and mentor junior team members to enhance departmental expertise. Documentation and Improvement: Generate, review, and approve technical documentation, and lead continuous improvement initiatives. Essential Requirements
Degree in Scientific, Pharmaceutical, or Engineering discipline or equivalent in experience. Proven experience in a qualification/validation role. Strong understanding of regulatory requirements and industry standards. Desired
Experience in biopharmaceutical or aseptic manufacturing environments. Familiarity with sterile manufacturing, lyophilisation, isolator technology, and biologics process development.
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