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.