Senior Process Engineer - Upstream/Downstream Manufacturing

About the Role and Organization

As a Senior Process Engineer for Manufacturing 7 (MFG 7) specializing in either Upstream or Downstream processes, you will report to the Manufacturing Technology Lead. You will be an integral part of forming the Manufacturing Technology team, providing essential engineering support to current operations at MFG 7 UPS or DPS and assisting future tech transfer projects into MFG 7.

WuXi Biologics is a globally recognized biologics service provider, supporting clients throughout discovery to commercialization stages across the biopharmaceutical and healthcare sectors. Our open access platform ranks us among the top three contract development and manufacturing organizations worldwide. Our mission is to accelerate and transform biologics development to improve patient lives around the globe.

Key Responsibilities

• Assist with site startup activities and project execution initiatives.
• Support package owners in managing vendors and addressing equipment and process-related inquiries.
• Develop and generate verification and validation documentation including protocols and reports for equipment.
• Review vendor documentation thoroughly to ensure completeness and accuracy.
• Participate in Factory Acceptance Tests (FAT) and other vendor engagement activities.
• Facilitate issue resolution during equipment installation, commissioning, and qualification stages.
• Lead or support verification and validation efforts, including qualification, and support the CQV execution team as needed.
• Ensure equipment design and testing meet process requirements, maintaining validated status for continuous reliable operation.
• Coordinate the delivery of robust processes and dependable equipment to achieve a Right First Time operating environment.
• Serve as the primary communication liaison with the Core Engineering group supporting MFG 7.
• Implement equipment corrective and preventive actions (CAPA) and enhance equipment performance.
• Lead and execute equipment verification, validation, and revalidation protocols.
• Provide technical equipment support and troubleshoot operational issues, including automation systems.
• Advocate and drive deployment of global requirement program tools, such as Operator Care, Predictive Maintenance (PdM), Project Management Office (PMO), and Work Management systems within the operation unit.
• Utilize Process Improvement (PI) technologies to identify business efficiencies and equipment improvement projects for the Core Engineering Unit.
• Engage with portfolio management to identify upcoming projects and support needs.
• Lead and promote energy conservation initiatives within the operating unit.
• Document equipment assessments to assist with investigation closures and trend investigations over time.
• Prepare and close change control documentation.
• Lead or provide subject-matter-expert (SME) input to cross-functional teams investigating manufacturing process, environmental, and water monitoring deviations, writing reports and technical assessments.
• Ensure timely closure of investigations, track recurring deviations, and implement root cause analyses and effective CAPA.
• Participate in cross-functional projects as needed.
• Collaborate with Manufacturing leadership to achieve operational objectives.
• Assist in audit preparations and coach manufacturing personnel on Operational Excellence (OpEx) tools and systems for continuous improvement.
• Implement initiatives to reduce cycle times and operational costs while improving equipment knowledge among production staff.
• Maintain databases for investigations and department tracking or data analysis as required.
• Complete biennial reviews and updates for Product Quality System (PQS).
• Support disposition processes ensuring timely data availability for disposition metrics.
• Perform duties in compliance with Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and controlled documentation.
• Flexibly undertake additional responsibilities at the discretion of the Manufacturing Technology Lead.
• Exemplify the company's corporate values and culture as a role model within Manufacturing and the wider organization.

Candidate Profile

• Third level qualification in Science or Engineering preferred.
• At least eight years of experience in large-scale biopharmaceutical or pharmaceutical manufacturing facilities.
• Experience in establishing Manufacturing Technology teams in a greenfield context of similar size and scale is highly desirable.
• Strong communication skills, both written and verbal, with computer proficiency; capable of working independently and collaboratively.
• Comprehensive understanding of current Good Manufacturing Practices (cGMP).
• Familiarity with the DeltaV Manufacturing Control System (MCS) platform is preferred.
• Knowledge or experience with Chromatography and Ultrafiltration production processes is advantageous.

Behavioral Competencies

• Proven leadership and management abilities.
• Critical thinking with effective troubleshooting and problem-solving skillset.
• Strong organizational skills with close attention to detail.
• Self-motivated and proactive initiative-taking.
• Ability to adapt to fast-paced environments and prioritize shifting workloads.
• Results-driven with capability to juggle multiple priorities simultaneously.
• Approach work collaboratively and inclusively across teams.
• Engage cross-functionally alongside site-based teams.
• Adherence to strong ethical standards, company policies, regulatory requirements, and client expectations.

Additional Information

• Willingness to travel internationally as required to fulfill job responsibilities.