Job Title: Sr Validation Engineer Role for Equipment Lifecycle Projects
This is a 12-month fixed-term contract position. It involves working in a hybrid environment as part of a dynamic team. As a Commissioning, Qualification and Validation (CQV) engineer for various capital and Equipment lifecycle projects, your role will be focused on ensuring the activities are completed safely, according to schedule and in compliance with GMP and Quality Requirements.
Key Responsibilities
* Commissioning and qualification support: Provide expert technical validation support to meet site objectives. This includes the full validation lifecycles process from initial design through qualification to validation maintenance.
* CQV project coordination: Coordinate qualification activities and maintain Equipment and utility systems in a validated state.
* Development of CQV strategies: Develop or qualify approaches and equipment family strategies.
* Quality risk assessments: Assist in the development of User Requirement Specifications (URS's) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).
* Plan and execute CQV activities: Development and approval of C&Q / Validation Plans, FAT, SAT IV/FTs, QRAES, IOQ's, PQ's etc. for the Vial and Syringe filling, formulation, inspection and utility areas in line with GMP's, regulatory requirements and corporate standards.
* Startup and commissioning: Ensure Startup of equipment/utilities is completed in a safe and coordinated manner.
* Interfacing with cross-functional teams: Liaise with Engineering, Commissioning and Qualification, manufacturing, planning and PD and external vendors regarding equipment User Requirement Specifications, Factory Acceptance Tests to ensure the quality by design principles are being followed.
* Process improvements: Assist in the development and improvements of the equipment validation lifecycle process while ensuring continued compliance to all necessary regulations.
* Regulatory inspections: Participate in regulatory inspections, regulatory filings and RTQ's (response to questions).
* SOP updates: Update and maintain Standard Operating Procedures (SOP's) in accordance with site and corporate requirements.
* Quality compliance: Take ownership for quality compliance in all activities you are responsible for, Ensuring approaches are aligned with current guidelines (ICH/ASTM).
* Site change control: Ensure the site change control procedure is adhered to.
Requirements
* Minimum 6 years experience in Science, Engineering or Validation, Commissioning and Qualification Management.
* Tertiary qualification at third level or equivalent in Engineering or science.
* Extensive knowledge and demonstrated experience managing Commissioning and Qualification for Pharmaceutical / Biotechnology projects.
* Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry.
* Experience of sterile / biotech equipment within the pharmaceutical industry is preferred.
* Experience qualifying filling, formulation and utility systems within the sterile manufacturing environment of drug product.
* Knowledge of safety, GMP and environmental regulatory requirements.
Benefits and Desired Skills
* Validation, Clean Utilities Experience.