Associate Director U.S. Automation Engineering (4032)

Associate Director - US Automation Engineering, Worcester MA

WuXi Biologics is a is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. WuXi Biologics' achievements are a direct result of the efforts made by our employees. We have built an extraordinary team motivated by our PROUD culture of Passion, Reward, Opportunity, Unity and Determination. WuXi Biologics offers exciting job opportunities and careers around the globe. We currently employ over 12,000 people and provide services to more than 600 customers worldwide, including all the top 20 biopharmaceutical companies.

Job Summary

The Associate Director US-Automation Engineering is responsible for defining, evaluating, and improving equipment processes and systems. The incumbent will introduce technology, and implement equipment reliability best practices by applying engineering and automated systems principles and technology. The person in this role is expected to have the technical expertise in Bioprocess equipment (single-use focused), and manufacturing systems, and have a good knowledge of cGMP operation. He or She will closely work with function teams and lead their team of process and automation engineers in the execution of equipment design, validation/life cycle management, and day-to-day operations support from a process and automation engineering perspective. It is essential for job success to have the ability to apply technical knowledge to create engineering solutions with regard to bioprocessing equipment and to conduct effective communication internally and externally to ensure the alignment of process and automation engineering approaches with project process requirements, regulatory strategies, and the industry best practices.

Responsibilities:

• Provide process and automation engineering design support by working with operation function teams and Global Engineering team to define process and automation operation equipment requirements.

• Manage small-to-mid-size projects related to process equipment, automation, and manufacturing.

• Lead and support the overall process and automation equipment life cycle management responsibilities from facility restart phase including but not limited to the generation of user-required specifications, start-up (FAT/SAT), I/O/PQ validation support, and change management.

• Be in charge of automation equipment maintenance system development including spare parts inventory and preventive maintenance program and continuous validation requirements for all AIS.

• Evaluate and improve manufacturing systems in collaboration with operations and engineering staff

• Maintain reliable and safe manufacturing systems while improving production rates, efficiencies, yields, reducing overall operating costs and minimize/optimize system changeovers.

• Serve as SME to provide support for cGMP manufacturing from process engineering perspectives with responsibilities of process equipment troubleshooting, deviation investigation, CAPA implementation, and engineering related audits/visits by clients and regulatory authorities

• Prepare necessary documentation to support engineering projects including project scopes, presentation of conceptual designs, capital requests, specifications, piping and instrumentation diagrams, process flow diagrams, schedules, requests for quotations, project expenditures, project procedure, correspondence, start-up procedures and cost estimates.

• Support QA and Validation departments by preparing design documents, user requirements specifications, and assisting in protocol generation and execution.

• Provide guidance and mentor Process and Automation Engineers within the Engineering Department.

• Ensure potential safety hazards are identified/shared and effective corrective actions are rapidly implemented. Establish site good engineering practices including but not limited to user requirement specifications, engineering/design specifications, process equipment-related SOP's, Policies and Procedures, etc

• Manage a professional staff of ~ 15 engineers that provide process automation support to enable a reliable and compliant supply of vaccines in our LVV and ROTA areas. This team of process automation engineers is responsible for: resolving automation events, implementation of process control improvements/corrective actions, data collection techniques, troubleshooting in compliance with GAMP, GMP, safety, and environmental regulations, and developing/maintaining System Development Life Cycle (SDLC) documentation.

• Drive a high-performance organizational culture that accommodates rapid growth and highly dynamic expectations ensuring attainment of site operational and development goals.

• Liaise with IT, Global AIS or Manufacturing Division Value Teams and broader IT to ensure business requirements are clearly understood and implemented, and sponsor technology adoption across the End-to-End and site to ensure value pull through on agreed business outcomes.

• Work collaboratively to drive a safe, compliant, and inclusive culture.

• Understand and support all GMPs, safety, and environmental regulations. Responsible for ensuring automation documents, preventive maintenance, periodic reviews and SOPs are in an inspection-ready state.

• Understand all aspects of GMP Change Control and Computer System Validation.

• Support process automation inquiries during internal and external audits/inspections and must therefore be able to speak knowledgeably about automation, process, and cGMP details of the manufacturing operations.

• Support and evaluate IT and OT systems and strategies to optimize and ensure the quality and stability of automation systems through future expansion, replacement, or upgrade.

• Ensure Life Cycle Management and Data Integrity initiatives, goals, and metrics are met for the LVV and ROTA end-to-ends; initiatives include equipment obsolescence and control system upgrades and ensuring projects are resourced appropriately and completed on time.

• Familiar with Six Sigma and lean manufacturing principles.

Leadership Competencies

• The following competencies outline the core leadership traits that this role should demonstrate and are seen as key to being successful in fulfilling the role.

• Collaboration: Strong collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and implementation of best practices.

• Strategic Thinker: Enterprise mindset, Innovative thinker, with excellent decision-making and problem-solving skills.

• Communicates Effectively: Strong importance on recognizing the audience and crafting the message accordingly. All aspects are important from technical or tactical discussions to strategic communications at an organization level.

• Ensures accountability: Ability to take responsibility to ensure success on any initiative and instill confidence in the team to drive to a positive outcome.

• Lean Manufacturing: Familiar with six-sigma and lean manufacturing principles

• Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.

Qualifications:

• M.S or B.S in Engineering or related biotechnology manufacturing discipline experience.

• Minimal 10 years of relevant biopharmaceutical process and automation engineering working experience with single use technology focused

• Candidate must possess extensive knowledge and experience in bio manufacturing engineering, automation systems and have solid understanding of cGMP facility requirements for a clinical biomanufacturing operation.

• Proven experience in risk mitigation planning and ability to solve complex manufacturing process engineering related problems. Ability to make appropriate judgment and rapidly troubleshooting issues to achieve cGMP production operation success.

• Excellent communications skills. Great team player and ability to build positive collaboration with internal stakeholders, vendors and clients to achieve alignment and work effectively.

• Must work in a self-motivated, highly flexible, well-organized and detailed-oriented style with requirement of some evening conference call time and occasional international travel.

• Must be able to wear appropriate PPE, ability to stand /Sit/walk for long periods of time, ability to Lift 50 lbs. occasionally.

WuXi Biologics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability