Key skills
Leadership
About this role
Role Overview
- Lead the development, execution, and validation of cleaning procedures for equipment, production lines, and facilities.
- Write and review cleaning validation protocols and reports in compliance with regulatory requirements.
- Coordinate and conduct sampling (e.g., swab, rinse, and surface) and analytical testing to validate cleaning processes and confirm cleaning effectiveness.
- Develop and maintain cleaning validation schedules to ensure timely completion of required validations.
- Review cleaning validation data, ensuring it meets established acceptance criteria, and make recommendations for process improvements.
Requirements
- Minimum 7 years of quality assurance experience with an undergraduate degree in engineering, science or related field.
- Minimum of 3 years of experience in contamination control and cleaning validation, preferably in a pharmaceutical or biotech manufacturing environment.
- Proven leadership experience in pharmaceutical, API/intermediate, drug product, biologics or related FDA industry.
- Strong knowledge of cGMP, FDA, EMA, ICH guidelines, and other regulatory standards related to contamination control and cleaning validation.
- Proficiency with risk assessment tools such as FMEA.
- Previous experience working in cross-functional and project-based environments.
- Experience creating metrics for driving continuous improvement.
- Certification in contamination control is highly desirable.
Benefits
- Comprehensive health & wellness benefits.
- Access to mental health resources and wellness programs.
- Generous PTO and holiday pay policies.
- Eligibility for performance-based bonuses.
- Attractive 401(k) Plan with company match.
- Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship.
- Tuition Assistance for Undergraduate and Graduate degree programs.