Job Title: Senior Validation Specialist
Location: Hybrid (Remote/Onsite at North Wales facility)
Type: Permanent, Full-time
Are you an experienced validation professional ready for your next big challenge? We are looking for a Senior Validation Specialist to join a leading biopharmaceutical company and play a crucial role in advancing our innovative projects and groundbreaking therapies.
In this exciting role, you’ll have the flexibility to work both remotely and onsite at our state-of-the-art facility in North Wales. You’ll be leading validation strategies that drive excellence in both aseptic and non-aseptic environments, making a real impact on our products and processes.
What You’ll Do:
- Lead Validation Efforts: Ensure ongoing validation of site facilities, utilities, and equipment, meeting industry standards and regulatory requirements.
- Strategic Execution: Define and implement validation strategies for critical projects, ensuring alignment with timelines and expectations.
- Requalification Activities: Develop testing strategies for requalification and revalidation, ensuring robust performance.
- Continuous Process Verification (CPV): Collaborate with cross-functional teams to manage and improve CPV processes.
- Regulatory Compliance: Present validation packages during audits and maintain up-to-date knowledge of regulatory trends.
- Risk Management: Use quality risk management principles to drive a risk-based validation lifecycle.
- Mentorship & Leadership: Lead investigations, solve nonconformance issues, and mentor junior team members to enhance expertise.
- Drive Continuous Improvement: Champion initiatives for enhancing operational efficiency and technical documentation.
What You’ll Bring:
- A degree in a Scientific, Pharmaceutical, or Engineering discipline (or equivalent experience).
- Proven experience in a validation or qualification role, with a strong understanding of regulatory requirements.
- A collaborative mindset, paired with the ability to lead and innovate.
- Experience in aseptic manufacturing or biopharmaceutical environments (preferred).
What’s in it for You?
- Hybrid working model: enjoy the flexibility of remote work with the opportunity to engage in hands-on projects onsite.
- Be part of a cutting-edge, forward-thinking team where your contributions drive real change.
- Leadership and growth opportunities in a supportive, collaborative environment.
Ready to take the lead in shaping our future? If you’re passionate about validation and want to work on meaningful projects with a top-tier biopharma company, we want to hear from you!
Apply now and make a difference in the world of healthcare.