Systems and Equipment Validation Manager
Read straight from Asahi Kasei's careers page, verified 1d ago.Seekless can tailor your résumé to it.
Seekless can write your résumé for this posting first.
Before you apply
SalaryNo pay range posted
LocationSaranac Lake, NY
Work modeon-site
Typefull-time
SenioritySenior
Company size10,000+ people
PostedOct 16, 2026 · 3w ago
Verified live1d ago
The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.
Bionique Testing Laboratories LLC (Bionique) has been a leading global provider of mycoplasma testing services for the biopharmaceutical industry for over 35 years. Bionique offers the full breadth of services from lot and Final Drug Product release testing per regulatory guidelines to a GMP compliant Real-Time PCR assay to support clients’ needs from concept to clinical trials and commercialization for biopharmaceutical and cell therapy products. Bionique’s experience and expertise extends to development and validation of rapid microbiological methods to support abbreviated release timelines. Additional services such as regulatory and compliance consultancy add to Bionique’s unique position in this niche analytical testing space. Located in Saranac Lake, NY, Bionique is an FDA registered and GMP compliant contract testing facility. Bionique aims to offer unsurpassed quality mycoplasma testing services to meet the specific scientific and regulatory needs of each client and partner.
Company:
Bionique Testing Laboratories LLC
Job Description:
Summary:
The Manager for Systems and Equipment Validation is responsible for overseeing the qualification or validation lifecycle of computerized systems, equipment, utilities, and related processes to ensure compliance with regulatory requirements (e.g., FDA, EMA, ICH, GAMP, GMP, ISO). This role ensures that validation activities are properly planned, executed, and documented, and that quality standards are maintained throughout the system and equipment lifecycle.
Key Accountabilities and Responsibilities: