The Mechanical Technician will report to the Senior Production Engineering Manager, this role is responsible for the reliable and GMP compliant operation of the Production related equipment on Manufacturing and Packaging machinery and supporting systems within the facility at Hatfield.
“To ensure that operations carried out within your area of responsibility are carried out in accordance with the requirements of the Quality System, GMP Guidelines and Industry Standards.”
General Responsibilities (Safety, Quality, Customer, Cost and Innovation)
Standard clauses for all employees:
To ensure that operations conducted are performed in accordance with the requirements of Corporate Standards, Eisai Quality System, GMP and GDP Guidelines and Industry Standards.
Duties are performed to ensure:
- A safe working environment is maintained for self and other employees, ensuring all near miss incidents and accidents are reported in accordance with procedures.
- The Quality of products manufactured and released is assured through adherence to all procedures.
- Opportunities to improve operations and reduce cost are identified and progressed through the continuous improvement and demand innovation initiatives.
- Company philosophies of hhc is at the forefront of daily activities.
- All stakeholder and customer expectations are understood and met through communication.
- Performance is in line with personal and Company objectives with demonstrated behavior’s and competencies.
Job Specific Responsibilities
- Maintenance, fault finding and repair of all Production Manufacturing and Packaging equipment, such that production priorities are met and the equipment performs to its optimum capability and maintains GMP compliance.
- Application of Good Manufacturing and Engineering Practices in all areas of responsibility
- Develop, follow, review and update procedures, job plans, certificates and standards.
- Setting maintenance regimes for equipment, implementing preventative, run time and reactive maintenance strategies
- Supervision of external contractors and equipment Vendors
- Modification to plant, manufacturing equipment and services.
- Assessment of critical spare requirements, ordering parts, planning shutdowns and workloads.
- Equipment failure reports.
- Co-ordination and participation in the development of risk assessment and method statements associated with specified work.
- Deviation investigations to define Corrective and Preventative actions and prevent re-occurrence.
- To fully understand and comply with all relevant Site SOP’s, cGMP and safety standards.
- Multi-disciplined, flexible attitude to team working.
- Identifying and implementing change control notifications
- Provide support to the production, technical and quality teams where required.
- Operation of the Computerised Maintenance Management System (CMMS).
- Advising on equipment selection, working with the Technical department to ensure robust solutions are implemented to ensure reliability.
- Commissioning activities to confirm that equipment will operate in accordance with design intent and to ensure installation and qualification tasks are executed smoothly
Skills and Qualifications
- Fault finding skills
- Aptitude for neat, clear and concise documentation.
- Multi-disciplined.
- Good communication and interpersonal skills
- Adaptable and flexible to cope with the changing needs of the production.
- A determination to understand breakdown/failure root cause and prevent reoccurrence.
- Ability to prioritise and plan own work.
- Computer literacy.