LotusWorks is an Engineering Services provider specializing in managing Commissioning, Construction Services, Calibration, Operations & Maintenance scopes of work within global manufacturing facilities. LotusWorks operates globally across EMEA and North America partnering with the world's leading manufacturers across the Semiconductor, Pharmaceutical & Biologics, Medical Device and Data Centre sectors. Our team of Engineering and Technical professionals is immersed in cutting-edge technologies and innovations. LotusWorks is committed to a diverse and inclusive workplace, integral to our people-first approach.
As a Validation Engineer II, you will lead and manage a team responsible for executing equipment and computerized system validation projects in a regulated medical device manufacturing environment. This role requires strong technical expertise, project leadership, and cross-functional collaboration to ensure compliance with global validation standards and drive continuous improvement.
Responsibilities:
- Responsible for the technical leadership and development of a validation project team.
- Responsible for the assignment of validation activities to the validation project team.
- Manage all aspects of Equipment & computerized system validation for any software systems used in the manufacture of medical devices.
- Prepare software validation protocols for the Equipment Engineering group. Execute these protocols and ensure sign-off is obtained at each stage.
- Creates and executes protocols and reports, reviews Equipment Function Spec's and provides direction and support on validation strategy and plans.
- Work with Quality department to ensure equipment validations are in line with global & Site validation standards.
- Ensure regulatory compliance with global software validation requirements.
- Ensure Computerized system validation procedure(s) is (are) kept up to date and maintained.
- Take responsibility for correctly carrying out and maintaining all validation and associated documentation for equipment.
- Provides software validation/compliance guidance and training to staff across various functions as required.
- Develops and enhances cross-functional team relationships and works cross-functionally to identify and resolve technical and organisational issues.
- Ensure best validation practices are employed by the Equipment Engineering Group so as to maximize effectiveness and minimise non-value added work.
- Communicates effectively & efficiently with cross-functional teams on project tasks
- Actively pursues continuous improvement.
- Complete project deliverables and monitor project schedule and scope changes to assure team can meet delivery requirements for related projects.
- Generates quotations, concepts and business cases for new and upgrade software systems.
- Project management of sustaining projects.
- Manages & mentors contract employees .
- Any other duties or responsibilities that may be assigned to you in your role
Skills Required:
- Minimum of 5 years’ experience in a Validation role within medical device, biotechnology or pharmaceutical manufacturing organization or equivalent.
- Proven track record and performance leading validation teams within manufacturing environment.
- Availability to travel as required.
- Ability to support weekend work as required.
Education / Licenses / Certifications:
- Level 8 qualification in Science/Engineering or Quality.
- Proof of education, licenses, and certifications will be required where applicable
Benefits:
- VHI Healthcare Cover
- Life Assurance
- Pension Contribution
- Training And Educational Assistance
- Annual GP Check-Up
- Extra Annual Leave
- Healthcare Screening
- Recognition Rewards
LotusWorks is an equal opportunity employer and prohibits discrimination and harassment of any kind. We are committed to creating a diverse and inclusive workplace where all employees feel valued, respected, and empowered.
