Overseas Site Engineering Project Management

WuXi Biologics; New Jersey; On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Work-life balance

Job summary

A global biopharmaceutical company in New Jersey is seeking an experienced Engineering Project Manager. The ideal candidate will lead engineering construction and validation projects, ensuring compliance with industry standards while managing schedules and costs. You will play a crucial role in feasibility studies, project documentation, and risk management. Candidates should have a Bachelor's degree in relevant fields and over 8 years of experience in the biopharmaceutical sector, preferably with project management and CQV expertise.

Qualifications

• Over 8 years of experience in engineering construction and validation in the biopharmaceutical industry.
• More than 5 years of full-process engineering project management experience.
• Hands-on experience in schedule and cost control of overseas site construction.

Responsibilities

• Lead feasibility studies and investment analysis for overseas site projects.
• Coordinate with technical teams for design reviews and compliance.
• Manage procurement strategies and contract negotiations.

Skills

Project Management

Communication

Risk Management

Construction Supervision

CQV Management

Education

Bachelor's degree in Chemical Engineering

Master's degree (preferred)

Tools

MS Project

Primavera P6

Job description

Participate in feasibility studies, site selection evaluation, master planning, and investment analysis for overseas site projects; assist in developing overall project plans, defining phase objectives, resource requirements, and key milestones to lay the foundation for design and execution.

Design Management & Technical Review

Coordinate with design institutes and technical teams to organize reviews of conceptual, preliminary, and detailed designs, ensuring compliance with company technical standards, GMP requirements, and local regulations; track design progress and resolve technical issues in a timely manner.

Procurement & Contract Management

Assist in developing procurement strategies and managing tendering for equipment, materials, and services; review supplier qualifications and technical proposals; participate in contract negotiations and oversee contract execution to ensure supply and service quality meet project requirements.

Construction & Schedule Control

Supervise site construction activities including civil works, installation, and utilities; develop and monitor construction schedules, identify and resolve factors affecting timelines to ensure completion of each phase as planned.

Full-process Engineering Validation Management

Lead commissioning and qualification (CQV) of utility systems, production equipment, instruments, and computerized systems; review validation plans, supervise execution, and verify reports to ensure compliance with ISPE guidelines, FDA/EMA, and other international standards as well as company requirements, ensuring facilities and equipment meet production and R&D needs.

Quality, Safety & Compliance Management

Promote EHS management during project execution to ensure construction and validation activities comply with company safety standards and local laws; organize quality inspections and acceptance to ensure engineering quality meets design and regulatory requirements.

Internal & External Coordination & Issue Resolution

Act as a liaison between the Company and external partners, establishing efficient communication with engineering teams, contractors, suppliers, supervisors, and regulators to promptly address technical, scheduling, and quality issues during project implementation and validation.

Project Documentation & Knowledge Management

Oversee the preparation, review, and archiving of all project and validation documentation to ensure completeness and traceability; establish a project knowledge base for future reference and continuous improvement.

Risk Management & Continuous Improvement

Proactively identify risks in design, construction, and validation phases, organize development of mitigation measures; conduct post-project reviews to capture lessons learned and drive continuous improvement.

Education & Major

Bachelor’s degree or above in Chemical Engineering, Bioengineering, Pharmaceutical Engineering, Electromechanical Engineering, Project Management, or other biopharmaceutical engineering-related fields; a master’s degree is preferred.

Work Experience

More than 8 years of experience in engineering construction and validation in the biopharmaceutical industry, and more than 5 years of full-process engineering project management experience; candidates with hands-on experience in schedule and cost control of overseas biopharmaceutical site construction are preferred; familiarity with the full process of factory and facility construction in CDMO/biopharmaceutical enterprises and proficiency in ISPE guidelines and GEP/GMP norms are preferred.

Project Management Capability

Ability to independently develop overall project plans, milestone schedules, and progress control systems; accurately identify deviations and implement effective corrective actions; hands-on experience in design management, procurement, construction, and handover processes.

Proficient in cost estimation, budgeting, and execution supervision; capable of cost analysis and variance alerts; able to control additional costs from design changes, procurement, and construction modifications to keep the project within budget.

Professional Technical Competence

Expert in full-process CQV management, with mastery of validation methods for utility systems and production equipment; familiar with international compliance standards (FDA/EMA/ICH) and regulations of at least one overseas country.

Certification Requirements

Holders of PMP/IPMP, Registered Constructor, Registered Utility Equipment Engineer, or EHS certifications are preferred.

Language & Communication Skills

English as a working language, fluent in oral communication, business negotiation, and written documentation; excellent cross-cultural communication and coordination skills.

Strong planning and organizational skills, able to integrate internal and external resources efficiently; highly responsible, resilient under pressure, results-oriented; proficient in MS Project, Primavera P6, and office software.

Cultural Fit

Alignment with WuXi Biologics’ corporate culture, strong teamwork spirit, holistic awareness, and commitment to global quality and compliance principles.