Senior Validation Engineer

ZipRecruiter; Middlesbrough; On-site; GBP 50,000 - 80,000; Full time

Job summary

A leading company is urgently seeking two experienced Senior Validation Engineers for a high-impact, 3-month contract role focusing on the development and qualification of single-use technology process equipment. Candidates should have extensive experience in validation processes and a solid understanding of GMP regulations to drive documentation alignment across teams.

Qualifications

• Minimum of 5–7 years of experience in equipment validation or process engineering in the pharmaceutical/biotech industry.
• Proven expertise in single-use systems and validation practices.
• Deep understanding of GMP regulations and industry standards.

Responsibilities

• Lead SME meetings and align teams on validation documentation.
• Draft and finalize validation lifecycle documents (URS, SRA, DIRA, DQ).
• Provide expert guidance on validation strategies for single-use systems.

Skills

Strong communication

Coordination

Leadership

Education

Bachelor’s degree in Engineering, Life Sciences, or related field

Job description

Job Description

JOB SUMMARY

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.

EDUCATION/QUALIFICATIONS

• 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.