Job description:

Reporting to the Associate Director for Process Engineering and Validation, the CQV Engineer plays a pivotal role in designing and executing critical Commissioning, Qualification, and Validation (CQV) activities for upstream and downstream processes, ensuring the seamless launch and sustained operational excellence of our processing facility. The CQV Engineer ensures that all manufacturing systems operate in accordance with design specifications, validated protocols, regulatory standards, and company directives. This role encompasses the orchestration of system enhancements, new introductions, vendor collaboration, change management, project leadership, and CQV oversight.

Key Responsibilities:

Lead the end-to-end qualification of facilities and equipment, managing the lifecycle from design to operational deployment.

Oversee equipment tracking and schedule management during project phases, ensuring timely system releases to operations.

Assure equipment and processes meet safety, effectiveness, and compliance standards set by industry norms and regulations.

Author, review, approve, and execute testing protocols, reports, and policies.

Champion company and site CQV and revalidation policies, maintaining procedural adherence.

Supervise compliant execution and reporting of revalidation initiatives for process and support systems.

Guide or lead technical transfers and Process Performance Qualification (PPQ) studies.

Manage project delivery, vendor interactions, and troubleshoot process systems.

Collaborate in multidisciplinary project teams across all project phases.

Initiate and conclude deviations, Corrective and Preventive Actions (CAPAs), and change controls, including related investigations.

Support introduction of new process materials and components.

Lead resolution of substantial production-related deviations and incidents.

Ensure inclusion of new process systems in maintenance and calibration programs.

Project-manage process system upgrades and modifications.

Undertake additional duties as assigned by direct manager, aligned with Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and controlled documents.

Embrace flexibility to embrace additional tasks and responsibilities per PEV Associate Director's discretion.

Model exemplary behavior for the Engineering function, reflecting WuXi's core values and PROUD culture.

Person Specification:

Technical Competencies:

Ideally, prior involvement in PEV in a 'greenfield' context of similar magnitude.

Substantial familiarity with process engineering equipment, systems, and processes within a tightly regulated manufacturing context.

Demonstrated capability to influence stakeholders, build robust relationships, and execute in line with PEV business strategy.

Experience:

Minimum of 3 years' experience in Biologics or equivalent GMP environment, within engineering, technical services, or operations.

Proficiency in commissioning and qualification of process equipment, including bioreactors, chromatography systems, ultrafiltration, autoclaves, and parts washers.

Expertise in troubleshooting and delivering engineering solutions for GMP manufacturing in biologics processing.

Hands-on experience within fully automated Delta V facilities.

Track record in developing CQV and revalidation program protocols, policies, and masterplans.

Familiarity with equipment vendor package ownership and system design coordination.

Advantageous Experience:

Exposure to temperature mapping (e.g., vessel SIP, autoclaves, cold rooms, refrigerators, freezers).

Participation in cleaning validation studies (e.g., spray ball coverage assessments, hold time studies, swab sampling).

Involvement in PPQ-related studies (e.g., process hold studies, chromatography resin, UF/DF membrane management studies).

Knowledge:

Technical and engineering comprehension of Upstream and/or Downstream biologics systems and processes.

Understanding/experience in GMP utility qualification and correlated systems/processes (e.g., WFI, Clean Steam, CIP, SIP).

Qualifications:

Required: B.Eng. or B.Sc. in Chemical/Process Engineering or relevant scientific discipline.

Advantageous: Postgraduate qualification in engineering or scientific field.

Advantageous: Qualification in project management.

Behavioral Competencies:

Effective communication, interpersonal, and presentation proficiencies.

Inclusive and collaborative approach to work and colleagues.

Strong problem-solving and troubleshooting capabilities.

Positive attitude, adaptability, and aptitude for team dynamics.

Engages cross-functionally with site-based teams.

Self-driven, autonomous, and proactive in driving actions.

Adheres to company procedures, policies, regulatory norms, and client expectations.

Fosters a Continuous Improvement Culture within the Engineering team.

Join Our Vision:

As we expand our global footprint, we seek individuals ready to embrace change and challenges, contributing to the creation of a new future. Go beyond yourself and uncover your true potential!

If you thrive in a dynamic, fast-paced environment and are poised to join us in achieving our mission – "Any drug can be made, and any disease can be treated" – don't miss out on this chance. Apply now!

Curious to Learn More? Visit us at https://www.wuxibiologics.com/join-us/ before applying.

Equal Opportunities Employer:

We are dedicated to fostering an inclusive and diverse work environment. We encourage all qualified individuals to apply, regardless of race, gender, sexual orientation, age, religion, disability, or any other characteristic. Your unique perspective and talents are what make us stronger.

We offer:

- Pension and Healthcare: Your well-being matters to us.

- Life Assurance: Providing security for you and your loved ones.

- Workplace Well-Being: Your health and happiness are a priority.

- Educational Assistance: We invest in your growth.

- Employee Assistance: Supporting you in every way we can.

- Sports and Recreation: A chance to stay active and refreshed.

- Onsite Dining: Enjoy delicious meals at a subsidized rate.

- Bike to Work Scheme: A pedal-friendly path to savings.

- Team Events: Collaborate and celebrate throughout the year.