- Experience Level
- Experienced (non-manager)
As a Validation Engineer you will be responsible for validating/qualifying the systems, equipment and utilities used in the development and clinical manufacture of a range of solid dosage forms.
An individual contributor role that applies technical, control system and engineering knowledge to the design and validation of new equipment, systems, and utilities within the solid dose manufacturing area.
The role will also include some safety and management of the full asset lifecycle. You will help to design robust manufacturing solutions and demonstrate systems are running according to necessary specifications and operate within regulations to ensure data integrity and the production of quality products.
Colleague will work closely with operational and technical teams within department to validate equipment, utilities, and systems. Colleague will be expected to interact with Global Workplace Solutions, Quality Assurance and Environmental Health and Safety to support the manufacture of solid oral dosage forms for clinical supply.
Educated to degree level in Mechanical, Bio Engineering, Biomedical Engineering or Chemical Engineering. Colleagues with lesser qualifications and 10+ years of relevant Pharmaceutical experience will also be considered.
Comprehensive technical knowledge and subject matter expertise in equipment, facility and utility asset lifecycle management from initial design and procurement through to validation and operational use.
Working Knowledge of GAMP 5 regulations.
Understanding of facility design and associated building management systems.
Suitable understanding of engineering operations including instruments, controls and mechanical aspects of manufacturing equipment and associated services.
A working knowledge of GMP and demonstrated understanding of compliance and quality management including change control and data integrity.
Experience of Safe Systems of Work and risk assessment tools used in both Quality & Safety areas beneficial.
Comprehensive experience of planning and organizational skills in the project management of operational aspects of capital projects.
Good interpersonal, organisational and communication skills (both oral and written) and demonstrated skills in team matrix working.
Proven ability to deliver technical reports and presentations.
Knowledge of solid dose manufacturing techniques is desirable.
Schedules and executes validations/qualifications per Standard Operating Procedures (SOPs), protocols and regulatory guidelines.
Coordinates and communicates all testing with affected functional groups and evaluates test results.
Executes validation activities to include Change Control initiation, protocol preparation, scheduling, Factory Acceptance Testing, protocol execution, data review and final report generation.
Responsible for completion of fully system lifecycle activities associated with equipment, utilities, or facilities from project initiation through to retirement / redesignation.
Participate in development / improvements to the validation program as needed to remain current with cGMPs and industry standards.
Participates on teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.
Participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).
Participate and present data in Regulatory Agency, Customer, Corporate and Internal audits when necessary.