Commissioning Engineer Monday Friday 08:00 17:00 The company is a UK leading organisation specialising in providing mains water and sewerage services in the English...
Carbon60 are currently looking to recruit an experienced NPI Validations Specialist/Engineer for a 10 month fixed term contract for the leading Pharmaceutical companies in the UK. Located in Castle Barnard this is an excellent opportunity to be in an integral part of a team focusing on the introduction of a new product within the new state of the are manufacturing facility.
In the role you will be exposed to a wide variety of new technologies for aseptic manufacturing, state of the art isolator technology including a high level of automation, robotics and digital, data and analytic systems. The role will be hands on in support of their installation and qualification.
Key Responsibilities include, but are not limited to:
- To support project / product completion in line with established timescales, through collaboration with teams and cross functional stakeholders (R&D, Technical and Quality teams), providing QA compliance leadership, active risk management, and problem solving.
- To contribute to an effective quality assurance and documentation oversight service which ensures that all operations comply with company GMP Standards and Product Quality Specifications.
- Contributing to the development of processes, review/approval of SOPs, maintenance plans and generation/approval of reports
- Supporting a continuous improvement culture within the team through the GSK Production System (GPS)
- Planning validation activities to ensure customer and business needs are met in alignment with the overall project plans and objectives; accountable for the validation and validation maintenance for Processes, Facilities, Equipment, and integration with CSV systems
- Supports Level 1 self-inspections
- Previous experience working within a highly regulated pharmaceutical or Biotech manufacturing environment.
- Able to complete IQ, OQ and PQ.
- Able to create summary reports, protocols and plans.
- Relevant engineering qualification ideally quality focused.
- Strong organisation skills.
- Happy to liaise with senior managers across various departments.
- Proven history completing site based validation projects.
- Demonstrable experience analysing complex data/information and making risk-based decisions as a result
For more information on this position please call the Carbon60 Engineering team or apply now.
Interviews for this role will be held week commencing 10th of February.
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. Carbon60 is a trading name of Carbon60 Limited an Employment Business/Agency.