GMP Facility Lead Darlington, North East England, England
Job description
About CPI
CPI helps make great ideas and inventions a reality. We’re a team of intelligent people using advances in science and technology to solve the biggest global challenges in healthcare and sustainability.
Through our incredible people and innovation infrastructure, we collaborate with our partners in industry, academia, government, and the investment community to accelerate the development and commercialisation of innovative products.
From health technologies and pharmaceuticals to sustainable food and materials innovations, we turn the entrepreneurial spirit and radical thinking of our people and partners into incredible impact that makes our world a better place.
Why this role is important for CPI’s work
CPI have an exciting opportunity to join the National Biologics Manufacturing Centre as a GMP Facility Lead. Joining the growing team, you will get the the chance to develop the GMP manufacturing clean rooms, whilst working alongside and with support from the established GMP Operations Team.
You will be responsible for supporting the cGMP manufacturing suites within the brand new, state-of-the-art, New RNA Centre of Excellence and Training Academy in Darlington, participating with all cGMP production manufacturing operations on site.
As the GMP Facility Lead, you will be working within the newly established RNA manufacturing division, assisting with completing manufactures to customers time lines & requirements. You will also be working alongside the established Technical Development Team, where you will actively contribute to a culture of continuous improvement of the GMP Clean rooms & Facility set up. Ensuring the Facility maintenance is carried out to a GMP standard.
Reporting into the Head of Operations, you will be expected to manage and oversee the coordination of the daily activities, ensuring cleaning, environmental monitoring and maintenance schedules are up to date and maintained to GMP high standards. You will also be contributing extensively to development and improvement activities, identifying, and addressing future needs of the team to deliver on area strategy.
You will ensure the required quality and safety standards are achieved and maintained with respect to cGMP operating procedures, all cGMP batch manufacturing documentation, area housekeeping in cGMP suites, SHE (Safety, Health & Environment), ensuring compliance with regulatory (MHRA Orange Guide etc) and legislative requirements.
An article explaining the exciting work happening at the RNA* centre can be found here: *Accelerating innovation in RNA
Key tasks in the GMP Facility Lead role will include (but are not limited to the below):
- Lead the area house Keeping for the GMP Facility, carrying out regular area patrols.
- Be the system Owner for the Building Management System (BMS) from a GMP perspective.
- Be the system Owner for the Environmental Monitoring System (EMS) from a GMP facility monitoring perspective.
- Identify KPIs and build business cases to improve the processes and systems in the GMP shared areas.
- Accountable for ensuring procedures across the GMP shared areas are compliant and tailored to business and collaborator needs.
- Act as a point of contact for team members’ queries and escalations with regards to any facility issues within the GMP areas.
- To actively engage in hazard studies / SRA studies and discussions, as appropriate to role level.
- To keep self-up to date with external developments in areas of specialism, and/or legislative and SHE related changes, ensuring application of new best practice and/or knowledge within the team.
The person we are seeking
We are looking for an individual with experience of working within a GMP, clean room environment Grade D & C. You will be capable of generating, reviewing, and approving GMP documentation such as Standard Operating Procedures, Batch records, cleaning schedules, non-conformance reports and out of specification results and can demonstrate evidence of building knowledge sharing and network building practice across teams and organisations to achieve desired results.
It is essential you are able to take responsibility for diverse or complex technical activities where it is necessary to use own initiative and judgement, implementing innovative solutions in business-critical situations. You must also have experience of Pharmaceutical manufacturing. You should at least be educated to degree level in a Scientific discipline or have relevant industry experience within a GMP environment.
It would be advantageous if you have experience of:
- Using TFF and Bioreactors with in a manufacturing or R & D environment
- Aseptic technique environmental monitoring back ground, OR
- Familiar with electronic Quality Management systems and electronic Environmental Monitoring.
What does CPI* offer you?*
At CPI, we offer a wide range of benefits to our employees, this includes:
- Up to 36 days holiday, including bank holidays – Plus a holiday purchasing scheme
- Generous pension scheme
- Life assurance and accident insurance schemes
- Flexible working
- Learning and Development Opportunities
- Free parking
Find out more about our culture and benefits.
Additional information
CPI is an organisation based in the UK. Commencement of employment is conditional to demonstrating right to work in the UK, sponsorship may be available.
Job Types: Full-time, Permanent
Salary: £32,000.00-£42,400.00 per year
