Reporting to the Site Engineering C&Q Manager the C&Q Engineer will support the execution of the Site’s Commissioning and Qualification Requirements. This person will drive the flawless and compliant execution of the assigned processes to meet customer and business needs while ensuring the processes are in compliance with regulatory requirements.
Roles and Responsibilities
Provide input into all aspects of qualification i.e. from design through to the commissioning and qualification execution phases
Participate in the design of systems and equipment to ensure that they comply with GMP requirements. Develop qualification documentation as required (e.g. specifications, plans, protocols, procedures).
Review and approve documents prepared by the C&Q team, other departments and contractor organisations (e.g. commissioning test plans, impact assessments, change controls).
Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports.
Prepare reports of executed protocols for review by QA.
Initiate and implement change control activities in accordance with site procedures.
Track and resolve exceptions during qualification activities.
Prioritize qualification activities in line with the site schedule.
Co-ordinate qualification activities with engineering, construction and commissioning activities.
Co-ordinate qualification activities with contractors and vendors as required.
Co-ordinate qualification document review and approval.
Commission and qualify equipment such as skids, vessels, fridges, freezers, incubators, BSC units, isolators as per site procedures.
Commission and qualify utility systems WFI, Clean Steam, Process Gas, HVAC as per site procedures.
How to Succeed
BSc qualification (Science or an Engineering related discipline)
At least 2 -5 years’ experience and a proven track record within a cGMP regulated environment
Experience of commissioning & qualifying GMP systems such as Utilities (water for injection, clean steam, process gases, HVAC, SIP/CIP), fridges, freezers, LAF, BSC units, autoclaves and isolators – as well as Process Equipment – Bioreactors, UF/DF, centrifuge, Chromatography systems.
Experience of Digital validation systems ( eg Kneat)
Temperature Mapping Experience
Experience of Analytical equipment qualification
Ability to work under pressure and meet deadlines.
Ability to work in a team.
Strong initiative and the ability to proactively identify required tasks.
This role offers a very competitive hourly rate. This contract will run for 12 months.
about Johnson & Johnson Innovative Medicine
Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.
Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.
We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.
Application Process
We are looking to process the first round of applications within the next 2 working days.
We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE, LTD & Umbrella options are available.
Diversity, Equity & Inclusion
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.
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