Global Device Engineering Lab Manager

Laboratory Equipment Management

Manage the full lifecycle of laboratory equipment and instrumentation, including procurement, qualification (IQ/OQ/PQ), Computer System Validation (CSV), commissioning, maintenance, and retirement.

Coordinate equipment vendors and service providers to ensure timely installation, calibration, maintenance, repair, and technical support.

Develop and maintain preventive maintenance schedules and calibration programs in accordance with manufacturer recommendations, quality requirements, and regulatory standards, on Blue Mountain RAM.

Establish and maintain equipment work instructions, operating procedures, and technical documentation.

• Investigate equipment-related deviations, including out-of-calibration events, and implement appropriate corrective and preventive actions.

Maintain laboratory asset records and equipment inventory within Blue Mountain RAM and SAP.

Deliver equipment-specific training and support to laboratory personnel to ensure safe and effective equipment operation.

Quality Management

Maintain compliance with cGMP, quality systems, data integrity requirements, and corporate standards across all laboratory activities.

Support and manage Quality System processes, including Change Control, Out of Specification (OOS) investigations, equipment qualification, CSV, and laboratory labeling requirements.

Own and maintain laboratory SOPs and controlled documentation, ensuring alignment with current regulatory and business requirements.

Monitor laboratory compliance metrics and generate periodic reports to support management review and continuous improvement activities.

Collaborate with Quality Assurance and cross-functional teams on audit preparation, address audit observations, deviations, CAPAs, and compliance initiatives.

Promote a quality-focused culture through adherence to procedures, documentation standards, and best practices.

Environmental Health & Safety (EHS)

Ensure compliance with site EHS policies, regulatory requirements, and corporate safety standards within the laboratory environment.

Coordinate and maintain laboratory risk assessments for equipment, testing activities, chemicals, and operational processes.

Manage the safe handling, storage, and disposal of chemicals, pharmaceutical materials, gases, and laboratory waste.

Maintain Safety Data Sheets (SDS), chemical inventories, and PPE stock levels to support safe laboratory operations.

Act as an active participant in EHS committees, audits, inspections, and incident investigations.

Collaborate with Facilities and Engineering teams to support gas management, chemical storage, and laboratory safety systems.

Drive a proactive safety culture through hazard identification, risk mitigation, training, and continuous improvement initiatives.

Laboratory Operations Management

Oversee day-to-day laboratory operations, ensuring efficient, effective, and compliant execution of laboratory activities.

Drive operational excellence through Gemba walks, Tier Board management, Kaizen, Kanban, and continuous improvement initiatives.

Manage laboratory supplies, consumables, and service requirements to ensure uninterrupted laboratory operations.

Coordinate laboratory contractors and service providers, ensuring appropriate permits, documentation, and site requirements are met.

Manage laboratory shipping and logistics activities, collaborating with Trade Compliance teams to support timely import and export processes.

Partner with Engineering, Facilities, Finance, Quality, and other cross-functional stakeholders to support laboratory infrastructure, utilities, compliance, and business requirements.

Monitor laboratory performance, identify opportunities for improvement, and implement sustainable solutions to enhance efficiency, productivity, and service delivery.

Foster a culture of accountability, collaboration, continuous improvement, and operational excellence while supporting the ongoing growth of laboratory capabilities.

Education / Experience / Skills

Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering or related technical discipline with a minimum of 10 years of related experience in both GxP and non-GXP environments.

Experience with Blue Mountain RAM, SAP, and MasterControl.

Excellent organizational, communication and documentation skills and ability to meet deadlines.

Excellent at balancing leadership with collaboration in a fast-paced goal-driven environment.

Quality-minded and Disciplined - maintains QA and EHS standards and promotes a culture of compliance.

Proactive and strives for continuous improvement, using data to make informed decisions.

Positive and resilient - maintains focus and momentum while navigating competing priorities and business demands.

About Keenova

At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support-showing up in big moments and small to help patients find comfort and confidence.

We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men's health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference.

We are Keenova-keen to solve, keen to serve.

Learn more at .

Keenova provides equal employment opportunities to applicants and employees without regard to race; color; gender; gender identity; sexual orientation; religions practices and observances; national origin; pregnancy, childbirth, or related medical conditions; protected veteran status; disability; or any other category protected by law. Additional information on Keenova's hiring practices may be found by clicking