Systems and Equipment Validation Manager
About The Position
The Systems and Equipment Validation Manager oversees the qualification and validation lifecycle of computerized systems, equipment, utilities, and related processes to ensure compliance with regulatory requirements, including FDA, EMA, ICH, GAMP, GMP, and ISO. The role ensures validation activities are planned, executed, and documented properly, and that quality standards are maintained throughout system and equipment lifecycles. The manager leads validation strategies for computerized systems, laboratory information management systems, laboratory equipment, and utilities; reviews and approves validation documentation; and provides quality assurance support for projects and lifecycle events. The role also supports audits, maintains validation plans and records, monitors performance indicators, and collaborates with internal departments and external vendors. It supervises and coaches direct reports, supports their performance and career development, and trains personnel on validation and compliance practices as needed.
Requirements
- Bachelor’s degree in a scientific, engineering, or related technical discipline, such as life sciences, chemistry, or engineering.
- At least 5 years of relevant experience in quality assurance or validation within a GMP-regulated industry.
- Strong knowledge of validation principles, including CSV, equipment, facilities, and utilities, and applicable regulatory guidelines.
- Demonstrated experience authoring and reviewing validation documentation.
- Excellent communication, analytical, and organizational skills.
Nice To Haves
- Familiarity with quality systems such as LabVantage, ZenQMS, BlueMountain, Veeva, or similar.
- Certification, such as ASQ or ISPE, or training in GAMP, risk-based validation, or data integrity.
Responsibilities
- Lead and manage qualification or validation strategies for computerized systems (CSV), laboratory information management systems, laboratory 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, including 21 CFR Part 11, Annex 11, and GAMP 5.
- Coordinate with QA in cross-functional project teams, including new system implementations and equipment commissioning, and represent Bionique’s Quality Systems with internal or external stakeholders as needed.
- 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.
- Support internal and external audits related to validation and system/equipment compliance.
- Maintain current knowledge of applicable regulations, standards, and industry best practices.
- Supervise and coach direct reports, including establishing goals, managing performance, planning career development, and providing ongoing support and guidance.
- Collaborate with internal departments and external vendors to ensure timely and compliant validation activities.
- Train personnel on validation and compliance practices as needed.
- Maintain validation master plans (VMP), equipment master lists, and associated quality documentation.
- Monitor and report key performance indicators (KPIs) for validation activities.
- Perform additional duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
