Cpl in partnership with our client Pfizer are looking to hire a CQV Engineer.
Experience in and an Understanding of isolator regulations and testing requirements.
To provide process and equipment engineering and technology support to the ongoing requirements of the Bulk Drug Substance, Vaccine Conjugation, Aseptic Processing and New Product Introduction Groups. This role will also involve qualification of an isolator.
The process equipment engineer is responsible for providing engineering and equipment qualification support to the operating units ensuring that the equipment is running as intended and that all equipment issues are resolved to support the manufacture and timely disposition of product.
This role focuses on resolving technical and engineering issues, implementation of CAPAs and process/equipment improvements, providing routine technical support and trouble-shooting, investigation closeout and maintaining the qualification status of the physical plant and equipment.
The process equipment engineer is responsible for project management and / or execution of assigned projects, which may include the coordination of internal company resources and vendors as part of the execution of projects. The process equipment engineer is responsible for providing technical expertise during audits and also to present / defend engineering systems, applicable change controls, investigations and equipment qualification packages to the regulatory agencies as required.
Responsibilities: The Process Equipment Engineer will report to a Manager in the Equipment Technology Team and should have the ability to:
o Ensure all equipment installed is safe, effective and in compliance with industry standards.
o Ensure all company and site engineering policies and procedures are adhered to.
o Provide technical and compliance review of testing protocols and reports.
o Lead or support major equipment related investigations and implement equipment CAPA and performance improvements.
o Lead or support minor to medium sized capital projects.
o Generate and execute documentation for cGMP validation, equipment & manufacturing processes, including validation plans, risk assessments, IQ/OQ/PQ/QV protocols and reports for the initial qualification of new equipment
o Write structured Engineering memo's in support of investigation closures.
o Provide routine equipment technical support and troubleshooting for resolution of manufacturing issues.
o Provide technical training on process and equipment as required by Operations.
o Develop and maintain productive links with process equipment & technology suppliers and vendors.
o Support Compliance Inspections and enquiries from Regulatory Agencies.
o Provide technical expertise during audits and also to present/ defend engineering systems, applicable change controls, investigations and equipment requalification packages to the regulatory agencies as required.
o Lead / represent Engineering on project teams where responsibilities would include SME technical oversight and the management and resolution of technical issues or changes arising throughout the project lifecycle whilst ensuring overall project objectives of scope, cost and schedule are adhered to.
o Work to implement a culture of Right-First Time through partnerships with Operations, New Product Introduction teams and Technical Services.
o Lead Method 1’s to determine root cause and implement corrective actions.
Qualifications and Experience required
o Minimum qualification of a Degree in Engineering particular emphasis on Process and Chemical disciplines or equivalent.
o Minimum of 5 years relevant experience in Engineering, Technical or Operations.
o Experience in qualification of isolators
o Understanding of isolator regulations and testing requirements.
o Experience working in an Engineering or Technical discipline with exposure to one or more of the following:
- Drug Product Aseptic processing
- Bulk Drug Substance manufacture
- Vaccine Conjugation
- Small molecule API
- Medical Devices
o GMP industrial experience, ideally covering Engineering, Projects and equipment qualification in a regulated environment.
o Ability to direct technical aspects of equipment installation, start-up, troubleshooting and repair or to obtain appropriate outside repair services to accomplish same.
o Demonstrated ability to provide technical solutions for complex problems through equipment and process understanding. Proficient in the use of structured problem solving tools such as Process Mapping, RCA (Root cause analysis), FMEA's (Failure Mode effects analysis) etc.
o Excellent communication and interpersonal skills and an ability to work independently