Director, GMFG-SEV

WuXi Biologics•Worcester, MA

6h•$147,000 - $250,000

About The Position

This position is responsible for leading and supporting the planning, design, construction, validation, and delivery of international biopharmaceutical manufacturing facilities. This role partners with global stakeholders to ensure projects are executed in alignment with company standards, regulatory requirements, and long-term operational strategy. The position focuses on advanced manufacturing integration, risk management, cost control, and scalable facility development to support global growth.

Requirements

Bachelor’s degree or above in Chemical Engineering, Bioengineering, Pharmaceutical Engineering, Mechanical/Electrical Engineering, Project Management, or related fields.
Minimum of 8 years’ experience in biopharmaceutical engineering, construction, and validation.
At least 5 years’ experience managing full-cycle engineering projects.
Strong knowledge of CDMO and biopharmaceutical facility development.
Proficiency in ISPE guidelines and GEP/GMP standards.
Proven ability to develop and manage project plans, schedules, and control systems.
Hands-on experience in design, procurement, construction, and handover.
Strong cost estimation, budgeting, and financial control skills.
Experience managing design changes and cost variances.
Fluent in English for professional communication, negotiations, and documentation.
Strong cross-cultural communication and stakeholder management skills.
Strong organizational, planning, and coordination abilities.
High accountability, resilience under pressure, and results-oriented mindset.
Proficient in MS Project, Primavera P6, and standard office software.
Alignment with WuXi Biologics’ culture and values.
Strong teamwork orientation and commitment to global quality and compliance standards.

Nice To Haves

Master’s degree preferred.
Experience with overseas site development and cost/schedule control preferred.
PMP, IPMP, Registered Constructor, Registered Utility Equipment Engineer, or related certifications.
EHS certifications preferred.

Responsibilities

Project Planning & Development Participate in feasibility studies, site selection, master planning, and investment analysis for overseas sites.
Develop overall project plans, defining objectives, resources, timelines, and milestones.
Support early-stage project planning to ensure successful execution.
Facility Design & Advanced Manufacturing Lead design reviews covering process flow, layout, logistics, and system architecture.
Establish global design standards integrating cGMP, lean manufacturing, and operational excellence.
Integrate automation, modular construction, digital factory solutions, and continuous manufacturing technologies.
Design facilities with flexibility for capacity expansion, upgrades, and new product introduction.
Develop standardized construction and operational models for global replication.
Design Management & Technical Review Coordinate with design institutes and technical teams to review conceptual, preliminary, and detailed designs.
Ensure compliance with company standards, GMP requirements, and local regulations.
Monitor design progress and resolve technical issues.
Project Delivery & Risk Management Oversee construction activities, including civil works, installation, and utilities.
Develop and manage construction schedules and ensure timely project delivery.
Establish global project milestones and KPI dashboards.
Identify and mitigate risks related to design, construction, supply chain, and validation.
Participate in critical project stages, including FAT/SAT, IQ/OQ/PQ, and trial production.
Procurement & Contract Management Support procurement strategies and tendering processes for equipment and services.
Review supplier qualifications and technical proposals.
Participate in contract negotiations and monitor contract execution.
Investment Management & Cost Optimization Monitor CAPEX budgets and manage contract changes.
Establish cross-site investment benchmarking systems.
Conduct lifecycle cost assessments for equipment and facility solutions.
Lead value engineering initiatives to optimize cost and performance.
Provide financial analysis to support capital investment decisions.
Commissioning, Qualification & Validation Coordinate commissioning and qualification of utilities, equipment, instruments, and computerized systems.
Review validation protocols and reports.
Ensure compliance with ISPE, FDA, EMA, and company standards.
Global Capacity & Strategy Collaboration Participate in global capacity planning and site selection.
Promote standardized systems and KPIs across regions.
Support global supply chain and facility standardization initiatives.
Collaborate with international teams to ensure alignment.
Quality, Safety & Compliance Ensure EHS compliance throughout construction and validation activities.
Organize quality inspections and acceptance processes.
Ensure compliance with company policies and local regulations.
Stakeholder Management & Continuous Improvement Act as a liaison between internal teams, contractors, suppliers, and regulators.
Resolve technical, schedule, and quality issues.
Conduct post-project reviews and drive continuous improvement.