CQV-Lead engineer
WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We´re one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing.
Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China, the US, the EU, and Asia. We currently employ over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies
GENG is responsible for capital and expansion construction projects per the Company's business strategic plan, and carry out all-round and whole-process project construction management, including due diligence report, design, civil, MEP and CQV, until delivering the biopharmaceutical R & D and GMP facilities to meet different needs; also providing business in terms of procurement, civil, MEP and CQV for external customers.
Location : Tuas Biomedical Park (Company shuttle bus provided islandwide)
Responsibilities :
- Responsible for overall management of the CQV projects. Including domestic projects and oversea projects.
- Responsible for the overall scope management of the project- including but not limited to project scope management, schedule management, progress management, resource allocation management, risk management& compliance management.
- Responsible for validation C&Q service provider management, provide guidance on company SOP requirement to vendors, and also need to be responsible for on-filed coordination & supervisory
- Support the development and implementation of C&Q plans aligned with project timelines, track the C&Q deliverables and activities to meet project timelines.
- Responsible for establishing and maintaining internal/external communication channels, actively coordinating all parties to work toward the same goal to ensure the project is delivered on time and to the required quality standards
- Complete trainings timely according to company training plan.
- Ensure compliance with appropriate regulatory requirements and WuXi Biologics requirements, and follow all EHS requirements.
Requirement:
- Bachelor degree or above, preferably in Engineering, Mechanical Engineering, Pharmaceutical Engineering, Chemical Engineering, or related fields.
- Demonstrated experience in validation or QA related work experience in cGMP environment (8 years as a guide), ideally in a multinational pharmaceutical/biopharmaceutical company.
- At least having 5 years of CQV project management experience.
- Have adequate knowledge about the biological pharmaceutical DP process would be an advantage, such as aspect filling.
- Have experience on the project/team management- having oversea projects management experience is a plus.
- Demonstrated experience in start-up facilities is preferred.
- Familiar with engineering pre-commissioning &equipment commissioning would be a plus.
- Good knowledge and experience of regulatory requirements (FDA, EMA) and industry standards (ISPE, PDA).
- Strong understanding of risk-based approaches to commissioning and qualification/validation
- Good understanding of Quality System, EHS.
Similar roles
Performance Engineer
Sourcedev·London, Canada
UK | Full-Time THE MISSION: SOURCE.DEV Our founders spent over a decade at Google shaping the Android operating systems - building and shipping the software that now runs on billions of devices. They didn't just use Android; they led teams responsible for the Android Virtualization Framework, Security, and the Android Runtime (ART). Through that journey, they saw a quiet but…
- On-site
- Full-time
- Express Entry — PR day one, no employer
Senior SRE Automation Engineer — Selenium/Playwright
es recruitment pte. ltd.·Singapore, Singapore
es recruitment pte. ltd. is seeking an Automation & Site Reliability Engineer (3 openings) for a banking technology team in Singapore. You will design and maintain automation solutions using Selenium/Playwright with Python/Java/TypeScript, build automation frameworks and ELK dashboards, and apply SRE practices to improve reliability. The role focuses on automation development, monitoring/observability and production support, with on-site work at Changi…
- Contract
- SGD 552–SGD 912 / yr
- Employment Pass — tied to employer
Senior M&A Strategist – Tech & Digital Infrastructure
ENGGSOL PTE. LTD.·Singapore, Singapore
ENGGSOL PTE. LTD. seeks a seasoned M&A professional to identify opportunities in IT, tech, and digital infrastructure. You will evaluate fit, build complex financial models, and lead deal structuring and execution. The role requires 5–8 years in corporate finance or related fields, with CFA/CPA preferred. You will coordinate across finance, legal, and external advisors to close transactions and drive post-merger…
- Full-time
- SGD 1k–SGD 2k / yr
- Employment Pass — tied to employer
Senior IT Projects & Delivery Lead
AvePoint·Singapore, Singapore
AvePoint is hiring a Project Manager/Senior Project Manager in Singapore. You will work with cross-functional teams, vendors, and customers to plan, execute, and monitor IT projects. Responsibilities include defining scope, budgets, schedules, and risks, while maintaining strong client communication and ensuring quality deliverables. Ideal candidates bring 8 years in project management, a PMP or PRINCE2 certificate, experience with SDLC, Waterfall…
- Full-time
- SGD 1k–SGD 2k / yr
- Employment Pass — tied to employer
Regional Marketing Director (Beauty, Skincare & Wellness)
HAACH LIFESTYLE HMH PTE. LTD.·Singapore, Singapore
Regional Marketing Director – Global Brand Expansion (Franchise & International Markets) Industry : FMCG/ Skincare & Beauty Retail Reports to : CEO Location : Singapore (Regional HQ – frequent international travel required) --- Overview We are a 29-year-old,established skincare brand built on trust, efficacy, and Singaporean heritage. Having conquered the domestic market, we are now entering our most exciting chapter:…
- Full-time
- SGD 1k–SGD 2k / yr
- Employment Pass — tied to employer
Senior Etch Engineer: AI-Driven Process Innovation
1100 Micron SemiAsiaOP Pte Ltd·Singapore, Singapore
Micron Technology, Inc. is seeking a Senior/Staff/Principal Engineer to join the PROCT and ADT teams in Singapore, focusing on the early maturity phase of new products transitioning to high-volume manufacturing. You will help improve yield, quality, and cost by applying semiconductor process development expertise and hardware/supplier management. Experience with NAND & DRAM integration and applying AI concepts to workflows is…
- Full-time
- SGD 2k–SGD 2k / yr
- Employment Pass — tied to employer
Platform SRE Lead — Reliability, AI-Driven Incident Response
JPMorgan Chase & Co.·Singapore, Singapore
JPMorgan Chase & Co. in Singapore seeks a senior Site Reliability Engineer to shape reliability culture and drive scalable, secure platforms. You will lead incident response, define SLOs, and mentor teams while leveraging AI-assisted workflows to improve observability and resilience. You will collaborate with cross-functional partners to reduce toil, optimize performance, and implement robust automation across the SDLC, including CI/CD…
- Full-time
- SGD 1k–SGD 2k / yr
- Employment Pass — tied to employer
Data Center Design Manager (36-month contract)
CBRE Group, Inc.·Singapore, Singapore
* Hiring Now! To support Hyperscale Data Center Environment * Contract Duration: 36 months * Location: Singapore About the Role The Data Center Design Manager to lead the planning, coordination, and delivery of mission-critical data center projects. You will be working with a multidisciplinary team, engage with clients and stakeholders, and ensure projects are delivered on time, within budget, and…
- Contract
- SGD 1k–SGD 2k / yr
- Employment Pass — tied to employer
