Job Opportunity

Job Opportunity

Director, GMFG-SEV

Director, GMFG-SEV

United States Posted 2026-03-02

Job Title - Director, GMFG-SEV

Work Location - Worcester MA

Job Summary

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.

Job Responsibilites

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.

Qualifications

Education

Bachelor’s degree or above in Chemical Engineering, Bioengineering, Pharmaceutical Engineering, Mechanical/Electrical Engineering, Project Management, or related fields.
Master’s degree preferred.

Experience

Minimum of 8 years’ experience in biopharmaceutical engineering, construction, and validation.
At least 5 years’ experience managing full-cycle engineering projects.
Experience with overseas site development and cost/schedule control preferred.
Strong knowledge of CDMO and biopharmaceutical facility development.
Proficiency in ISPE guidelines and GEP/GMP standards.

Project Management & Technical Skills

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.

Certifications (Preferred)

PMP, IPMP, Registered Constructor, Registered Utility Equipment Engineer, or related certifications.
EHS certifications preferred.

Language & Communication

Fluent in English for professional communication, negotiations, and documentation.
Strong cross-cultural communication and stakeholder management skills.

Professional Competencies

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.

Cultural Fit

Alignment with WuXi Biologics’ culture and values.
Strong teamwork orientation and commitment to global quality and compliance standards.

The anticipated salary range for this position is $147,000 - $$250,000

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

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