Job Title: Validation Engineer
Department: Technical Operations
Position Reports to: Technical Operations Lead
Provide Validation engineering leadership in the area of sterilization science and technology to the ongoing requirements of the Parenterals Operating Unit. The Validation engineer is responsible for providing engineering and equipment qualification support to the operating unit ensuring that the equipment is safe, available, and efficient and that all issues are resolved to support the manufacture and timely disposition of product.
This role focuses on maintaining the validated state of our sterilization processes, leading and resolving technical issues within the Operations Unit, implementation of CAPAs and process/equipment improvements, supporting the Engineering Technician population in the provision of routine technical support.
The Validation engineer is responsible for providing technical expertise during audits and also to present/defend engineering systems, applicable change controls, investigations and equipment qualification packages pertaining to the validated status to the regulatory agencies if required.
• Subject matter expert for Parenterals validation process (Isolator VHP, Autoclave and SIP)
• Maintain the validated status of the equipment in the Parenteral facility by coordinating, planning, executing and reporting on the requalification schedule.
• Generate and execute documentation for cGMP validation, requalification and periodic review of systems, equipment & manufacturing processes, including validation plans, risk assessments, protocols and reports to maintain the equipment in a validated state.
• 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 and/or authorship of testing protocols, reports and applicable manufacturing SOPs.
• Support investigations to providing appropriate root cause analysis, product/process impact assessments and effective CAPA implementation
• Provide routine equipment technical support and troubleshooting for resolution of manufacturing issues related to Validation.
• Provide technical training on process and equipment within Validation program.
• Develop and maintain productive links with process equipment & technology supplier and vendors.
• Provide technical expertise during audits and also to present/defend engineering systems, applicable change controls, investigations and equipment requalification packages pertaining to validated status to the regulatory agencies if required.
Minimum qualification of a B. Sc. Degree in Engineering, Science or equivalent with particular emphasis in Biochemical, Chemical or Mechanical discipline.
Previous experience in a Pharmaceutical Validation Role is essential. The ideal candidate will have significant aseptic manufacturing experience in a validation role supporting parenteral manufacturing.
Extensive knowledge of Aseptic Manufacturing including Sterilization Science and technology (VHP and Steam Sterilization).
In depth understanding of process/equipment engineering for all unit operations and potential impact of equipment on product.
Note: Specific experience with autoclaves, SIP processes and Vaporised Hydrogen Peroxide processes is highly desired.
Extensive knowledge of production operations, scheduling, design, planning, process evaluation, equipment selections calculations etc.
Experience working with automated control systems.
Experience of direct interaction with regulatory agencies during audits.
Excellent communication and interpersonal skills and an ability to work independently.