As a Senior CSV Engineer you will be involved in the design, construction and qualification activities for the upstream and downstream packages to enable start-up of the processing facility and for the ongoing process engineering activities during sustaining operations.
The Senior CSV Engineer is responsible for ensuring that all manufacturing process systems perform and operate as per their design. The Senior CSV Engineer ensures that all systems, conform to relevant regulatory requirements as well as company specifications and standards. The Senior CSV Engineer will oversee the implementation of both manufacturing process and utility/infrastructure changes including new system introductions and existing system improvements and enhancements. This includes design, vendor selection, change control, project management and qualification activities.
In this role will report to the PEV Associate Director
Essential Duties and Responsibilities
Manage the engineering equipment design - provide design and coordination support between the site and the package vendors.
Ensure the site is continuously aligned with EudraLex GMP and all applicable cGMP guidelines.
During the project phase, be responsible for equipment tracking and managing the schedule from design through to system release to operations.
Ensure all equipment and processes are safe, effective and in compliance with industry standards and regulatory expectations.
Authorship, review and approval of testing protocols and reports.
Act as owner for all CSV related policies and procedures.
Responsible for oversight of project delivery, vendor enquires and the troubleshooting and monitoring of process systems.
Lead CSV elements on project teams through all phases of projects - conceptual and detailed design, equipment procurement, construction, installation, start up, commissioning and qualification, and system release.
Responsible for initiation and completion of deviations, CAPAs, and change controls for process systems including investigations relating to equipment or process performance.
Ensure that new process systems are included in the plant maintenance and calibration program.
Project management of process system upgrades and modifications.
Perform all duties in accordance with GMP requirements, SOPs and controlled documents.
Act as a mentor and coach to specialist CSV engineers within the PEV team.
Will be flexible to take on additional tasks and responsibilities at the discretion of the PEV Associate Director.
Will act as a role model for the Engineering function and the wider organisation in adherence to the
WuXi corporate core values and PROUD culture.
Experience
A minimum of 8 years’ experience working in a Biologics or similar GMP environment as part of an engineering, technical services or operations function.
Knowledge and experience with facility start-up projects (brown field or green field) would be an advantage.
Experienced in the execution and coordination of CSV deliverables for process equipment (e.g. bioreactors and process vessels, chromatography, ultrafiltration, autoclaves, parts washers).
Experience in troubleshooting and providing technical and engineering solutions for GMP manufacturing operations and equipment in a biologics processing environment.
Experience operating in a fully automated Delta V facility.
Experience of equipment vendor package ownership and system design coordination.
Knowledge
Technical / engineering knowledge of Upstream and / or Downstream biologics systems and processes.
Knowledge / experience in the qualification of GMP utilities and associated systems and processes (e.g. WFI, Clean Steam, CIP, SIP).
Qualifications
B. Eng or B. Sc in Chemical / Process engineering or relevant science or engineering discipline is required.
A postgraduate qualification in an engineering or science discipline would be advantageous.
A qualification in project management would be advantageous.
Behavioural Competencies
Excellent communication, interpersonal and presentation skills.
Collaborative and inclusive approach to work and your colleagues.
Excellent problem solving and troubleshooting skills.
Ability to lead /direct cross function teams and strong project management skills.
Flexible approach to work and a positive attitude will be a good fit within the team dynamic.
Engage cross functionally in conjunction with a site-based team.
Autonomous and a self-starter who will use their initiative to drive actions forward.
Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our clients’ expectations.
Drive a Continuous Improvement Culture within the Engineering team.
As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential!
If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our vision - Any drug can be made, and any disease can be treated - don’t miss out on this opportunity to join us and reach beyond yourself and discover your true potential. Apply Now!
Would you like to know more before you apply? Please visit us at https://www.wuxibiologics.com/join-us/
WuXi Biologics is an equal opportunities employer.