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. 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.
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.
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.
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.
Ensure all equipment installed is safe, effective and in compliance with industry standards.
Ensure all company and site engineering policies and procedures are adhered to.
Provide technical and compliance review of testing protocols and reports.
Lead or support major equipment related investigations and implement equipment CAPA and performance improvements.
Generate and execute documentation for cGMP validation, requalification and periodic review of systems, equipment & manufacturing processes, including validation plans, annual revalidation plans, risk assessments, IQ/OQ/PQ/QV protocols and reports to maintain the equipment in a validated state.
Write structured Engineering memo’s in support of investigation closures.
Provide routine equipment technical support and troubleshooting for resolution of manufacturing issues.
Provide technical training on process and equipment as required by Operations.
Develop and maintain productive links with process equipment & technology suppliers and vendors.
Support Compliance Inspections and enquiries from Regulatory Agencies.
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.
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.
Work to implement a culture of Right-First Time through partnerships with Operations, New Product Introduction teams and Technical Services.
Lead Method 1’s to determine root cause and implement corrective actions.
Implement process improvement projects.
Qualifications & Experience:
Minimum qualification of a Degree in Engineering or Science with particular emphasis on Process, Chemical and Mechanical disciplines.
Minimum of three years relevant experience in Engineering, Technical or Operations.
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.
GMP industrial experience, ideally covering Engineering, Projects and equipment qualification in a regulated environment.
Understanding of Pharma / Bio-pharma process equipment including: Process Vessels, Chromatography, Ultrafiltration, Autoclaves, CIP systems, Parts washers, and Clean Utilities.
Ability to direct technical aspects of equipment installation, start-up, troubleshooting and repair or to obtain appropriate outside repair services to accomplish same.
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.
Excellent communication and interpersonal skills and an ability to work independently.
QTS training for events, commitments and change controls.