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- Tasks: Lead validation activities and draft essential lifecycle documents for biopharmaceutical equipment.
- Company: Join a dynamic team focused on innovative single-use technology in the biotech industry.
- Benefits: Enjoy a high-impact contract role with opportunities for professional growth and collaboration.
- Why this job: Be a key player in shaping biopharmaceutical processes while working with cross-functional teams.
- Qualifications: Bachelor’s degree and 5-7 years of experience in validation within pharma/biotech required.
- Other info: This is a 3-month contract role with potential for future opportunities.
The predicted salary is between 43200 - 72000 £ per year.
We are urgently seeking two experienced Senior Validation Engineers for a high-impact, 3-month contract role focused on the development and qualification of single-use technology process equipment. This role requires individuals who can independently lead validation activities and function as Subject Matter Experts (SMEs) to drive alignment and document completion across multiple stakeholders.
The successful candidates will be instrumental in drafting, coordinating, and completing lifecycle documents such as User Requirements Specifications (URS), System Risk Assessments (SRA), Data Integrity Risk Assessments (DIRA), and Design Qualification (DQ) documents.
MAIN RESPONSIBILITIES- Lead and facilitate SME meetings to align cross-functional teams on validation requirements and documentation strategies.
- Draft, review, and finalize validation lifecycle documents (URS, SRA, DIRA, DQ) in compliance with internal procedures and regulatory expectations.
- Provide expert guidance on validation strategies for single-use systems used in biopharmaceutical manufacturing.
- Ensure timely execution and approval of documentation to meet project timelines.
- Collaborate with engineering, quality, manufacturing, and regulatory teams to ensure alignment and compliance.
- Support risk assessments and design reviews for process equipment.
- Escalate issues and recommend mitigation plans where necessary to ensure project continuity.
- Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
- Minimum of 5–7 years of experience in equipment validation or process engineering within the pharmaceutical/biotech industry.
- Proven expertise in single-use systems and associated validation/documentation practices.
- Deep understanding of GMP regulations and industry standards (FDA, EMA, ICH).
- Demonstrated experience leading SME meetings and validation lifecycle documentation.
- Strong communication, coordination, and leadership skills.
- Experience working in fast-paced, project-driven environments.
- Prior experience with regulatory audits and inspections.
Senior Validation Engineer (Middlesbrough) employer: Project Delivery Partners
Contact Detail:
Project Delivery Partners Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Validation Engineer (Middlesbrough)
✨Tip Number 1
Network with professionals in the biopharmaceutical industry, especially those who have experience in validation engineering. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in single-use technology.
✨Tip Number 2
Familiarise yourself with the specific regulatory requirements and standards relevant to the role, such as GMP regulations and FDA guidelines. This knowledge will not only help you in interviews but also demonstrate your commitment to compliance and quality assurance.
✨Tip Number 3
Prepare to discuss your previous experiences leading SME meetings and drafting validation lifecycle documents. Be ready to provide examples of how you've successfully navigated challenges in cross-functional teams and ensured alignment on validation strategies.
✨Tip Number 4
Research StudySmarter and our values, particularly how we approach innovation in the biopharmaceutical sector. Tailor your discussions during interviews to reflect how your expertise aligns with our mission and how you can contribute to our projects.
We think you need these skills to ace Senior Validation Engineer (Middlesbrough)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in equipment validation and process engineering, particularly within the pharmaceutical or biotech industry. Emphasise your expertise in single-use systems and any relevant regulatory knowledge.
Craft a Compelling Cover Letter: In your cover letter, explain why you are the perfect fit for the Senior Validation Engineer role. Mention specific experiences that demonstrate your ability to lead validation activities and your familiarity with drafting lifecycle documents like URS and DQ.
Showcase Your Leadership Skills: Provide examples of how you've successfully led SME meetings and collaborated with cross-functional teams. Highlight your communication and coordination skills, as these are crucial for this role.
Highlight Relevant Qualifications: Ensure you mention your educational background and any certifications related to engineering or life sciences. Also, include your years of experience in the field and any specific training related to GMP regulations and industry standards.
How to prepare for a job interview at Project Delivery Partners
✨Showcase Your Expertise
As a Senior Validation Engineer, it's crucial to demonstrate your deep understanding of single-use systems and validation practices. Be prepared to discuss specific projects where you've successfully led validation activities and how you ensured compliance with GMP regulations.
✨Prepare for Technical Questions
Expect technical questions related to User Requirements Specifications (URS), System Risk Assessments (SRA), and Design Qualification (DQ) documents. Brush up on these topics and be ready to explain your approach to drafting and reviewing these critical documents.
✨Highlight Leadership Skills
Since the role involves leading SME meetings and coordinating with cross-functional teams, emphasise your leadership experience. Share examples of how you've facilitated discussions and driven alignment among diverse stakeholders in previous roles.
✨Demonstrate Problem-Solving Abilities
Be prepared to discuss how you've handled challenges in past projects, particularly regarding risk assessments and design reviews. Highlight your ability to escalate issues and recommend effective mitigation plans to ensure project continuity.
