What are the responsibilities and job description for the Sr. Cleaning Validation Engineer/Manager position at ELIQUENT Life Sciences?
About Company:
Who Are We?
ELIQUENT Life Sciences is a leading global consulting group delivering regulatory affairs, pharmacovigilance, quality, and compliance solutions that support pharmaceutical, biotechnology, medical device, and combination product companies across therapeutic modalities, phase-based pathways, and major global markets.
Why explore your future at ELIQUENT?
ELIQUENT Life Sciences is a trusted global consulting firm helping life sciences companies navigate regulatory complexity and bring breakthrough therapies to market. Founded by former regulators and industry experts, we offer end-to-end support in regulatory affairs, pharmacovigilance, and quality compliance. Our team is driven by a shared mission to improve global health through innovation, collaboration, and integrity. At ELIQUENT, you will be part of a purpose-led organization where your expertise contributes to meaningful impact and your growth is supported every step of the way.
About the Role:
- 10 years in pharma/biotech/medical device validation - some biologics experience is required.
- Strong multi-discipline validation expertise, including:
- Cleaning Validation
- Utilities (PW, WFI, HVAC, compressed air)
- Equipment Qualification (IQ/OQ/PQ)
- Computer Systems Validation (CSV, GAMP 5, Part 11)
- Shipping/Distribution Validation
- Proven leadership / people management experience
- Deep knowledge of:
- FDA 21 CFR Part 11, 210/211
- EU GMP Annex 11
- ICH Q7 / Q10
- Strong technical writing and document review skills
- Experience supporting FDA inspections / audit readiness
- Bachelor’s required; advanced degree preferred