Qualification & Cleaning/Sterilization Validation SME (Subject Matter Expert)

Headhunter: LHH

Pharmaceutical Industry

6305 Zug - Schweiz

Senior Specialist / Project Manager

Hybrid

Experteer Overview

In this role you will lead qualification and validation efforts to ensure systems, processes, and documentation meet GMP standards and stay inspection-ready. You’ll act as the site SME on Qualification and Cleaning/Sterilization Validation, partnering with cross‑functional and global teams to define strategies and deliver compliant, high‑quality validation programs. The position combines technical expertise with leadership to drive improvement, standardization, and regulatory alignment. You will shape validation practices across the site and support regulatory inspections with expert guidance. This opportunity offers impact in a dynamic pharma setting, with a focus on quality, compliance, và

Responsibilites

Lead and supervise equipment qualification, CSV, and cleaning/sterilization validation projects
Coordinate with cross-functional and global stakeholders to implement best practices and ensure compliance
Define, plan, and execute validation strategies ensuring timely delivery
Develop and review qualification/validation documentation (SOPs, protocols, reports)
Ensure validation activities meet GMP and internal quality standards
Support regulatory inspections and act as a key contact for validation topics
Lead root cause investigations and support deviation/change management
Evaluate new equipment/technologies from a validation perspective
Harmonize, streamline, and drive simplification of validation practices across the site
Provide expert guidance and direction aligned with TLE leadership

Key requirements

Bachelor's or Master's degree in Engineering, Biotechnology, Biology, Microbiology, or related field
Minimum 5 years of experience in pharmaceutical or regulated environment
At least 2 years hands-on experience in: CSV, Equipment Qualification, Cleaning & Sterilization Validation
Strong knowledge of GMP regulations, industry standards, and regulatory expectations
Experience auditing, inspections, and compliance in pharma
Solid experience in Change Control and Deviation Management
Strong project management skills with delivery focus
Ability to lead cross-functional projects and drive implementation
Excellent communication and stakeholder management
Demonstrated ability to work in a global, cross-functional environment
Strong problem-solving and root cause investigation skills
Ability to drive process improvements, standardization, and simplification initiatives