全职 CQV Engineer - Senior, Facility - Equipment 工作, 薪水 up to SGD 10,000, WUXI BIOLOGICS BIOPHARMACEUTICALS SINGAPORE PRIVATE LIMITED Central Region (Singapore) 公司招聘中 - Ricebowl

Department Description

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.

Your Responsibilities

Responsible for participating qualification/validation of factory buildings, temperature control equipment, wet heat sterilization systems, and clean ventilation equipment.

Review C&Q deliverables, either from internal or from equipment suppliers / C&Q service providers, develop C&Q documents if required;

Participate in qualification execution;

Participate in resolution of validation variance, change control assessment occurred in the project phase;

Participate in validation C&Q service provider management, provide guidance on company SOP requirement to vendors;

Support the development and implementation of C&Q plans aligned with project timelines, track the C&Q deliverables and activities to meet project timelines.

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, Automation, HVAC, Chemical Engineering, or related fields.

5 - 8 experience in validation or QA related work experience in cGMP environment within pharmaceutical/biopharmaceutical company.

Demonstrated experience in start-up facilities is preferred.

Familiar with one or more of the following systems: Factory buildings, temperature control equipment include the process, system design.

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, Hand-on experience with qualification/validation lifecycle (URS, DQ, FAT, SAT, IQ, OQ, PQ) for clean utilities.

Good understanding of Quality System, EHS.

Excellent interpersonal, verbal, and written communication skills

Able to think critically and demonstrate troubleshooting and problem-solving skills

Self-starter and self-motivated; organized with good attention to detail

Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities