Co-Project Director for Facility Design and Construction

Job Title - Co-Project Director for Facility Design and Construction

Work Location - Worcester MA

Job Summary

This position acts as a co-lead, representing the user and manufacturing teams, working closely with the Global Engineering Project Director to ensure seamless alignment between facility design, construction, and manufacturing requirements. The role focuses on delivering world-class biopharmaceutical facilities by integrating advanced manufacturing solutions, optimizing material and personnel flows, and ensuring scalability for future operational demands. This role provides primary support for the establishment and operation readiness of the U.S. site while also supporting overseas sites as required. Additionally, this position will play a critical role in capacity planning, lifecycle cost optimization, flexible facility design, and compliance to regulatory and operational standards

Job Responsibilities

1. Project Planning & Development

• Represent manufacturing operations and user teams in feasibility studies, master planning, and investment analysis for global manufacturing facilities.
• Develop integrated project plans with clear alignment to manufacturing operational needs, defining objectives, timelines, milestones, and resources for successful project execution.
• Collaborate closely with Engineering, Manufacturing, and Finance departments to ensure feasibility and alignment of project goals.
• Actively work with cross-functional stakeholders to ensure project planning addresses both operational and long-term strategic goals.
• Support both domestic U.S. operations and overseas facilities across key phases of project planning and execution.

2. Facility Design & Advanced Manufacturing

• Lead facility designs tailored to accommodate efficient manufacturing workflows, including material flow, personnel flow, and process integration, while adhering to cGMP and regulatory requirements.
• Work collaboratively with the Global Engineering Department as well as Local Facility Engineering teams to ensure WuXi corporate and local compliance requirements and standards are fully implemented.
• Incorporate construction solutions, digital factory technologies, and continuous manufacturing systems into facility designs to streamline manufacturing processes and ensure flexibility.
• Ensure facility layouts enable scalability for capacity expansions, production line upgrades, and new product introductions, meeting both short-term and long-term manufacturing requirements.
• Collaborate with engineering and manufacturing teams to optimize facilities for lean manufacturing workflows, ensuring cross-contamination prevention, cleanroom consistency, and efficient product handling.
• Facilitate multi-product manufacturing by designing adaptable production lines that support diverse product portfolios.

3. Capacity Planning & Manufacturing Scalability

• Collaborate with manufacturing planners to conduct capacity feasibility studies, ensuring facilities meet global manufacturing demand and future scalability.
• Develop scenarios for manufacturing capacity expansion, covering infrastructure upgrades, expanded production lines, and utilities to support pipeline growth.
• Identify bottlenecks in manufacturing workflows and provide facility-based solutions to optimize throughput, uptime, and operational yield.
• Oversee the application of flexible systems to accommodate fluctuating throughput needs and scheduling across product lines.

4. Project Delivery & Operation Readiness

• Oversee construction, commissioning, and validation activities, ensuring seamless integration of design and manufacturing workflows.
• Collaborate with project and manufacturing teams to ensure alignment of CQV (commissioning, qualification, and validation) activities with manufacturing readiness timelines.
• Coordinate with manufacturing leads to ensure validation schedules (IQ/OQ/PQ) align with manufacturing operation priorities and minimize disruptions during startup.
• Ensure compliance with global regulatory guidelines (FDA, EMA) and internal company quality standards across all construction, validation, and operational readiness stages.
• Actively identify risks during design, construction, and validation phases, implementing mitigation strategies to ensure timely and effective delivery of manufacturing capabilities.

5. Procurement, Investment, and Cost Optimization

• Assist in procurement processes for manufacturing-critical equipment and infrastructure, ensuring technological compatibility, reliability, and operational fit.
• Monitor and manage CAPEX budgets, ensuring facility investments align with operational and strategic manufacturing outcomes.
• Conduct lifecycle cost assessments and lead value engineering initiatives to drive long-term cost efficiency across equipment and facility operations.
• Collaborate on investment benchmarking to evaluate performance and ensure competitiveness of global manufacturing infrastructure.

6. Material & Personnel Flow Optimization

• Partner with manufacturing teams to design facility workflows that optimize material and personnel handling, minimize contamination risks, and enhance safety and operational efficiency.
• Ensure the facility maintains distinct, well-optimized zones for raw materials, intermediates, finished goods, waste management, and cleanroom processes.
• Align facility processes with operational requirements for lean manufacturing, including efficient material movement and ergonomic personnel flow across all facility zones.

7. Stakeholder Collaboration & Continuous Improvement

• Act as a liaison between manufacturing, project engineering, Global Engineering teams, contractors, and regulatory bodies to ensure alignment of goals throughout design and construction phases.
• Proactively address technical bottlenecks and coordinate resolution processes to meet manufacturing milestones while maintaining operational flexibility.
• Conduct post-project reviews to identify opportunities for improvement and ensure lessons learned are integrated into future facility projects.

Education

• Bachelor's degree or above in Mechanical Engineering, Chemical Engineering, Bioengineering, Pharmaceutical Engineering, Electrical Engineering, Project Management, or related fields.
• A Master's degree in the above fields is preferred.

Experience

• A minimum of 8 years of experience in biopharmaceutical engineering, facility design, construction, commissioning, and validation.
• At least 5 years managing large-scale, full-cycle global engineering projects, with a strong focus on manufacturing setup and operations integration.
• Proven experience working in CDMO companies specializing in Single-Use technologies, and handling cross-national and cross-cultural projects is highly preferred.

Technical Skills

• Expertise in biomanufacturing process equipment, facility layouts for lean manufacturing, and contamination control.
• Proven ability to manage CAPEX budgeting and cost control through lifecycle assessments and value engineering.
• Skilled in risk mitigation, project tracking solutions (MS Project, Primavera P6), and process optimization related to manufacturing workflows.

Language, Communication & Competencies

• Fluent in English for professional communication, documentation, and cross-functional collaboration.
• Strong leadership, project coordination, and cross-cultural communication skills to effectively manage stakeholders from diverse disciplines and global regions.

The anticipated salary range for this position is $134,200 - $228,500

The job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender