Laboratory Operations Manager – Quality & EHS

Keenova Therapeutics plc; Dublin; On-site; EUR 70,000 - 110,000; Full time

Job summary

Keenova Therapeutics plc in Dublin, Ireland seeks a Laboratory Manager to lead and optimize engineering labs, ensuring compliant operation of equipment, QA and EHS in GxP and non-GxP settings. The role oversees lab infrastructure, calibration, documentation and continuous improvement to support medical device development.

You will drive equipment lifecycle, vendor coordination, training, and safety programs while partnering with QA, Facilities and cross-functional teams to deliver high-quality

Qualifications

• Bachelor degree with minimum 10 years in both GxP and non-GxP environments.
• Experience with RAM, SAP and MasterControl is a plus.
• Excellent organizational, communication and documentation skills and ability to meet deadlines.
• Balance leadership with collaboration in a fast-paced setting.
• Quality-minded and disciplined, promoting QA and EHS standards.

Responsibilities

• Manage the full lifecycle of laboratory equipment and instrumentation, including procurement, qualification (IQ/OQ/PQ), 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.
• Establish and maintain equipment work instructions, operating procedures, and technical documentation.
• Investigate equipment-related deviations, including out-of-calibration events, and implement CAPAs.
• 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.
• 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.

Skills

Leadership

Communication

Documentation

GxP knowledge

Education

Bachelor of Science degree

Tools

Blue Mountain RAM

SAP

MasterControl

Job description

Keenova Therapeutics plc in Dublin, Ireland seeks a Laboratory Manager to lead and optimize engineering labs, ensuring compliant operation of equipment, QA and EHS in GxP and non-GxP settings. The role oversees lab infrastructure, calibration, documentation and continuous improvement to support medical device development.

You will drive equipment lifecycle, vendor coordination, training, and safety programs while partnering with QA, Facilities and cross-functional teams to deliver high-quality