Associate Director, GAIS US Regional Automation Lead

Job Responsibilities

• Lead SIP team and technical SME's of Global AIS in the US region to provide capital project delivery together with GAIS project manager.
• Provide post-construction support and continuous improvement to WuXi Bio and affiliation’s development and Manufacturing business through automation, digitalization and advanced Operational Technologies.
• Develop regional business’s automation and digitalization plan, budget and roadmap. Present ROI for new CAPEX project, and provide oversight on the quality of project delivery.
• Maintain and improve client relations and facilitate stakeholder communication; provide technical solutions and proposal to customers; prepare progress report for management review.
• Lead or facilitate engineering standards of automation aspect; automation related SOPs harmonization, common automation related training across WuXi Biologics
• Lead or facilitate internal capability development, such as new technology introduction, premium service establishment, and new product development that can contribute to company’s value stream.
• Support global tech forum for best practice, technology sharing, global policy alignment to form strong global-local AIS community.
• Support external or internal audits to local sites in terms of audit preparation as well as prepare SMEs to face the audits.
• Coach and keep growing the team’s technical competence and service capability
• Active participation in strategic planning and business processes to shape company vision and goals.
• Providing insights and recommendations that align with long-term objectives.
• Will act as a role model for the global AIS function and also the wider organization in adherence to the WuXi corporate core values and PROUD culture.
• Regular inter-departmental meetings and workshops to align teams with strategic direction.
• Managing, navigating and resolving inter-departmental challenges/priorities for the best interest of the company.
• Working closely with local sites and above site senior leaders from manufacturing, quality, engineering and regulatory affairs and automation/digitalization needs to identify improvement areas and align efforts.
• Developing and implementing SIP strategy at both regional and global level;
• Identify improvement opportunities and turn opportunities into executable projects with improvement goals for more automated process, better data management and compliance, and higher equipment robustness and availability.
• Utilizing WBS, Lean and Six Sigma methodologies to enhance operational performance.
• Leading and participating in cross-functional initiatives to drive efficiency and innovation.
• Responsible for the on-going Global AIS team development through coaching and mentoring and continuously improving the capabilities of the team.

Qualifications

• Experienced and proven track record in establishing and managing an AIS function and team in a pharmaceutical or biologics facility.
• Demonstrable ability to influence senior leaders, build strong relationships and drive a global AIS strategy.
• Experience: Degree in Electrical, Instrument, Mechanical or Chemical Engineering, or other relevant degree; BS with 15+ years or Master’s with 12+ years or PhD with 9+ years of experience in operation, technical service, or project management.
• Prior working experience in chemical /biochemical industry; familiar with biologics drug manufacturing process.
• Prior working experience within global company setup and culture; able to communicate and work across regions and time zones.
• Strong customer service, coordination, and interpersonal skills; must have team leading and personnel management experience.
• Proven ability to lead cross-functional and technical teams and align, motivate and empower team members.
• Proficient with at least one major brand DCS /SCADA system and related deployment experience following GAMP5 validation.
• In-depth understanding of facility construction project control and management, MEP, commissioning, and handover requirement.
• Good knowledge on key process equipment in a typical DS or DP facility.
• Basic IT knowledge. Good familiarity and learning experience with industry 4.0 framework, IIOT, advanced analytics and Digitalization/AI tools.
• General knowledge on GMP regulation and requirements; familiarity with BPE (Bioprocess Equipment) Guide is a plus.