CQV Engineer

at  WuXi Biologics

As CQV Engineer you will be responsible for the design and CQV activities for the upstream and downstream packages to enable start-up of the processing facility and for the ongoing CQV activities during sustaining operations. The CQV Engineer is responsible for ensuring that all manufacturing process systems perform and operate as per their design and validated state. The CQV Engineer ensures that all systems conform to relevant regulatory requirements as well as company specifications and standards. This role will support 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 CQV activities.

DEPARTMENT DESCRIPTION

As CQV Engineer you’ll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives.
In this role you’ll be reporting to the Associate Director of Process Engineering and Validation.

Experience:

• Ideally experienced in the PEV function within a ‘greenfield’ context of similar size and scale.
• Significant experience with relevant process engineering equipment, processes, and systems in a highly regulated manufacturing environment.
• Demonstrable ability to influence key stakeholders, build strong relationships, and execute the PEV business strategy.
• A minimum of 3 years’ experience working in a Biologics or similar GMP environment as part of an engineering, technical services, or operations function.
• Experienced in the execution of commissioning and qualification of process equipment (e.g., bioreactors, 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 in establishing the procedures, policies, and masterplans that define a CQV and revalidation program.
• Experience with equipment vendor package ownership and system design coordination.
• Experience with temperature mapping (e.g., vessel SIP, autoclaves, cold rooms, fridges, and freezers).
• Experience executing cleaning validation studies (e.g., spray ball coverage assessments, hold time studies, and swab sampling).
• Experience executing PPQ-related studies (e.g., process hold studies, chromatography resin, and UF/DF membrane management studies)

Technical and Engineering Knowledge:

• Technical and engineering knowledge of Upstream and/or Downstream biologics systems and processes.
• Knowledge and 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 discipline is required.
• A postgraduate qualification in an engineering or scientific discipline would be advantageous.
• A qualification in project management would be advantageous

Skills and Attributes:

• Excellent communication, interpersonal, and presentation skills.
• Collaborative and inclusive approach to work and with colleagues.
• Excellent problem-solving and troubleshooting skills.
• Flexible approach to work and a positive attitude, fitting well within the team dynamic.
• Ability to engage cross-functionally with a site-based team.
• Autonomous and a self-starter who uses their initiative to drive actions forward.
• Strong ethics in adhering to company procedures and policies, regulatory standards, and client expectations.
• Ability to drive a Continuous Improvement Culture within the Engineering team

• In this role, you will Manage the facility and equipment qualification – from design through to operational use.
• 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 qualified in compliance with industry standards and regulatory expectations.
• Authorship, review, approval and execution of testing protocols, reports, and policies.
• Act as steward for all company and site CQV and revalidation policies and procedures.
• Oversee the compliant execution and reporting of all revalidation activities for process and support systems.
• Support / lead technical transfer activities and associated PPQ studies.
• Responsible for project delivery, vendor enquiries and the troubleshooting and monitoring of process systems.
• Participate 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.
• Support the introduction of new process materials and components to the site.
• Support / lead the resolution of significant production related deviations and events.
• Ensure that new process systems are included in the maintenance and calibration program.
• Project management of process system upgrades and modifications.
• Perform additional duties at the request of the direct manager.
• Perform all duties in accordance with GMP requirements, SOPs and controlled documents
• 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.
  Your Profile: The ideal candidate for this position, will have the following:

Experience:

• Ideally experienced in the PEV function within a ‘greenfield’ context of similar size and scale.
• Significant experience with relevant process engineering equipment, processes, and systems in a highly regulated manufacturing environment.
• Demonstrable ability to influence key stakeholders, build strong relationships, and execute the PEV business strategy.
• A minimum of 3 years’ experience working in a Biologics or similar GMP environment as part of an engineering, technical services, or operations function.
• Experienced in the execution of commissioning and qualification of process equipment (e.g., bioreactors, 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 in establishing the procedures, policies, and masterplans that define a CQV and revalidation program.
• Experience with equipment vendor package ownership and system design coordination.
• Experience with temperature mapping (e.g., vessel SIP, autoclaves, cold rooms, fridges, and freezers).
• Experience executing cleaning validation studies (e.g., spray ball coverage assessments, hold time studies, and swab sampling).
• Experience executing PPQ-related studies (e.g., process hold studies, chromatography resin, and UF/DF membrane management studies).

Technical and Engineering Knowledge:

• Technical and engineering knowledge of Upstream and/or Downstream biologics systems and processes.
• Knowledge and 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 discipline is required.
• A postgraduate qualification in an engineering or scientific discipline would be advantageous.
• A qualification in project management would be advantageous.

Skills and Attributes:

• Excellent communication, interpersonal, and presentation skills.
• Collaborative and inclusive approach to work and with colleagues.
• Excellent problem-solving and troubleshooting skills.
• Flexible approach to work and a positive attitude, fitting well within the team dynamic.
• Ability to engage cross-functionally with a site-based team.
• Autonomous and a self-starter who uses their initiative to drive actions forward.
• Strong ethics in adhering to company procedures and policies, regulatory standards, and client expectations.
• Ability to 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 can 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 mission - 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 WuXiBiologicsCareers.com
WuXi Biologics is an equal opportunities employer