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: Validation Oversight: Lead and manage qualification or validation strategies for computerized systems (CSV), laboratory information management systems, lab equipment, and utilities. Review and approve validation documentation including URS, risk assessments, IQ/OQ/PQ protocols, test scripts, and final reports. Ensure adherence to internal SOPs and global regulatory guidelines (e.g., 21 CFR Part 11, Annex 11, GAMP 5). Quality Assurance (QA) Support: Coordinate with QA in cross-functional project teams (e.g., for new system implementations or equipment commissioning) and may represent Bionique’s Quality Systems with internal or external stakeholders. Participate in change control, deviation investigations, and CAPAs related to validated systems and equipment. Provide QA oversight during system lifecycle events such as upgrades, decommissioning, and requalification. Audit & Compliance: Support internal and external audits (regulatory agencies, clients) related to validation and system/equipment compliance. Maintain up-to-date knowledge of applicable regulations, standards, and industry best practices. Team & Stakeholder Collaboration: Supervise and coach direct reports including establishing goals, performance management, career development planning, and providing support and guidance on an ongoing basis throughout the employment lifecycle to achieve goals Collaborate closely with all internal departments and external vendors to ensure timely and compliant validation activities. Train personnel on validation and compliance practices as needed. Documentation & Metrics: Maintain validation master plans (VMP), equipment master lists, and associated quality documentation. Monitor and report key performance indicators (KPIs) for validation activities. Additional duties as assigned Qualifications: Bachelor’s degree in a scientific, engineering, or related technical discipline (e.g., life sciences, chemistry, engineering). 5+ years of relevant experience in quality assurance or validation within a GMP-regulated industry. Strong knowledge of validation principles (CSV, equipment, facilities, utilities) and applicable regulatory guidelines. Demonstrated experience in authoring and reviewing validation documentation. Excellent communication, analytical, and organizational skills. Familiarity with quality systems such as LabVantage, ZenQMS, BlueMountain, Veeva, or similar is a plus. Certification (e.g., ASQ, ISPE) or training in GAMP, risk-based validation, or data integrity is a strong advantage. Physical Demands and Work Environment: Prolonged periods of sitting on a chair, working at a desk, and working on a computer and/or telephone Pushing/Pulling/Lifting up to 25 pounds Standing/Walking/Mobility: must be able to stand to open files and operate office and laboratory equipment for prolonged periods; mobility to move between offices and colleagues required Must successfully pass a pre-employment physical and medical evaluation; specific immunizations may be required Must be able to wear required personal protective equipment (PPE) Compensation: The base compensation range for this role is between $95,000/yr - $110,000/yr. As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment. Be cautious of fraudulent communications claiming to be from Asahi Kasei. Incidents have occurred in which individuals impersonating Asahi Kasei recruiters have contacted people on LinkedIn requesting personal information. If someone does not have a verification badge, that person is not authorized to engage in recruitment activities on behalf of Asahi Kasei. Please also note that we never ask applicants to make any payments in the recruitment process. If you receive any suspicious messages or recruitment outreach that does not meet these criteria, please do not respond, and report the matter directly to LinkedIn. Asahi Kasei in North America emphasizes recruiting key talent within the region. Across our multiple business units, we focus on growth, innovation, and initiative to help develop our people and give them the resources they need to succeed. Part of our mission is to be a good corporate citizen, dedicating our time to employees, customers, and communities around us. As an employer, Asahi Kasei offers a comprehensive benefits package, growth opportunities throughout our companies, and a diverse environment to enhance your career. About Asahi Kasei The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 46,000 employees around the world, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Material, Homes, and Health Care. In North America, Asahi Kasei currently has over 23 business units and 10,000 employees. Our People Asahi Kasei recognizes that our people are our greatest strength. We operate with an emphasis on developing our employees and promoting from within. Our broad spectrum of companies within the Material, Homes, and Health Care sectors allows employees to collaborate across locations and industries. The possibilities for employees will continue to grow as we accelerate new business activity internally and externally through mergers and acquisitions. For assistance in submitting your application or with the careers site, please reach out to Asahi-WFP@ak-america.com. Please note we do not accept resumes or applications via email. Don't see an opening that matches your skills? Setup job alerts by selecting Sign In, located in the upper right of the page, to create an account.

Systems and Equipment Validation Manager.

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