OVERALL ROLE OBJECTIVE
An opening has arisen for a GMP Equipment Validation Engineer to join TC BioPharm Ltd (TCB), an established, fast-growing immunotherapy company developing future cancer and infectious disease treatments. Based at their manufacturing facility in the central belt of Scotland, the successful candidate will report directly to the Facilities Manager. Our unique culture, values and working environment attracts, retains, and inspires people to give their best.
The post holder will provide support to the facilities department. They will be responsible for supporting services, ensuring the smooth introduction and validation of new equipment and maintaining validation of existing equipment. The post holder will work within the Facilities team and support Quality, Manufacturing and Product Development teams to ensure operational excellence. The post holder will work with their Manager, to ensure that all facility activities are appropriately scheduled and conducted as well as ensuring that the facility meets regulatory requirements to comply with company manufacturing licenses.
RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
- Planning and performing IQ, OQ and PQ of Incubators, fridges, freezers and room thermal mapping activities
- Effective use of software used in the performance and documentation of validation and calibration of equipment.
- Preparation and management of validation plans, protocols and reports
- Adherence to TCB Quality policies and procedures
- Support Production team in validation activities for processes and equipment
- Management and supervision of contractors
- Performing general Facilities duties
- Generation of solutions to problems and input to validation system improvement.
- Fulfil team duties and where appropriate training others.
QUALIFICATIONS
- An Engineering degree would be advantageous however time skilled engineers with validation experience working within a life sciences environment will be considered
SKILLS & EXPERIENCE
- A minimum of 3 years’ experience within a GMP regulated environment.
- Experience in performing IQ, OQ and PQ of Incubators, fridges, freezers and room thermal mapping activities
- Knowledge and expertise of software used in the performance of validation and calibration of equipment.
- Ability to prepare plans, protocols and reports
- Ability to follow processes and procedures
- Ability to think outside the box and generate solutions.
- Must be an active champion of change.
- Excellent written/oral communication and interpersonal skills
- Excellent Microsoft Office skills
- Thorough approach and high attention to detail
- Strong time management and organisational skills
If you are looking to work within a challenging, dynamic, and rewarding environment, then TCB represents an excellent career move. This is an opportunity to be part of a growing, ambitious business where people development is critical to future success. As we continue to expand, there will be career opportunities on a truly global scale.
TCB is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.
Together with a competitive salary, we offer a comprehensive range of benefits and an excellent working environment.
Full-time, permanent role, working 37.5 hours per week Monday to Friday. Some ad hoc irregular working hours may be required.