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 appropriately 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 ensures adherence to internal procedures and regulatory guidance. The role works with Quality Assurance and cross-functional teams on implementations and commissioning, supports change control, deviations, CAPAs, and lifecycle events, and assists with audits. It also supervises and develops direct reports, coordinates with internal departments and external vendors, provides training, and maintains validation plans, equipment records, quality documentation, and performance metrics. This position is with Bionique Testing Laboratories LLC, an FDA-registered, GMP-compliant contract testing facility in Saranac Lake, New York. The stated base compensation range is $95,000 to $110,000 per year.
Requirements
- Bachelor’s degree in a scientific, engineering, or related technical discipline, such as life sciences, chemistry, or engineering.
- Five or more years of relevant experience in quality assurance or validation within a GMP-regulated industry.
- Strong knowledge of validation principles for computerized systems, equipment, facilities, and utilities, and applicable regulatory guidelines.
- Demonstrated experience authoring and reviewing validation documentation.
- Excellent communication, analytical, and organizational skills.
- Ability to meet the described physical demands, including pushing, pulling, or lifting up to 25 pounds; standing, walking, and moving between offices and colleagues; and wearing required personal protective equipment.
- Must successfully pass a pre-employment physical and medical evaluation; specific immunizations may be required.
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, 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, such as new system implementations and equipment commissioning, and represent Bionique’s Quality Systems with internal or external stakeholders as appropriate.
- Participate in change control, deviation investigations, and CAPAs related to validated systems and equipment.
- Provide QA oversight during system lifecycle events, including upgrades, decommissioning, and requalification.
- Support internal and external audits related to validation and system or equipment compliance.
- Maintain current knowledge of applicable regulations, standards, and industry best practices.
- Supervise and coach direct reports, including setting 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, equipment master lists, and associated quality documentation.
- Monitor and report key performance indicators for validation activities.
- Perform additional duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
