Global Recruiters of Dublin (GRN Dublin) is hiring: Cleaning Validation Engineer

Overview

Senior Recruiter/Business Development Manager at Global Recruiters of Dublin | Certified Sourcing Professional. Lead the development and execution of cleaning validation design, qualification, and validation protocols for various equipment and systems.

Responsibilities

• Lead the development and execution of cleaning validation design, qualification, and validation protocols for various equipment and systems.
• Responsible for all phases (stages 1, 2 and 3) of the cleaning validation activity, including requirements gathering, validation planning, protocol generation, test execution, design documentation, and system release.
• Execute validation activity in a timely manner, planning and proactively pursuing details to ensure project completion without avoidable delays.
• Evaluate System Change Controls for Validation Impact. Support Change Qualification through the creation of relevant Change Actions.
• Support the development of Standard Operating Procedures for new processes and equipment.
• Interpersonal skills to manage interactions and achieve results across a range of functions within the site. It may also extend to external communication with system vendors.
• Serve as Principal Investigator for cleaning validation-related excursions.
• Contribute to the continuous improvement of validation processes and procedures.
• Support other areas of validation, as needed, including equipment, sterilization, utilities, and facilities.

Qualifications

• Bachelor’s degree in engineering or relevant sciences and 6+ years of validation experience, with specialization in cleaning validation.
• Knowledge and experience with all phases/stages (1, 2 and 3) of cleaning validation, including maximum carryover calculations for limits assessment, HBEL, ADE/PDE, NOEL, VRL, cycle development, rinse and swab method analytical and recovery studies, sample collection, worst case assessment for equipment and products, spray ball coverage testing, continued cleaning process verification after equipment release.
• Experience with cleaning validation of Formulation/Filling vessels, Filling equipment (e.g., manifolds/needles), CIP skids and Parts Washer.
• 6+ years’ experience with sterile injectables, combo-devices, or biologics.
• Experience with personnel training for visual inspection and swab qualification.
• Advanced degrees or certifications relevant to the role is a plus.
• Knowledge of regulatory requirements (cGMP, FDA, WHO, etc.).
• Experience authoring, approving, and executing cleaning validation protocols for major pharmaceutical manufacturing facilities, utilities, and equipment.
• Self-directed with problem-solving, analytical, and technical skills.
• Ability to think strategically and tactically (detail-oriented).
• Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment.
• Experience in a process improvement environment, including change management and participating in Lean/Six Sigma project teams.

Preferred Qualifications

• Experience with single-use components in drug product formulation, process validation, sterile filtration, and aseptic filling applications.
• Start-up experience preferred.

Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Industries: Pharmaceutical Manufacturing

Benefits

• Medical insurance
• 401(k)