Project Manager (C&Q Engineering)

• Involved from the initial User Requirement Specification (URS) through Factory Acceptance Test (FAT) Site Acceptance Test (SAT) Installation Qualification (IQ) Operational Qualification (OQ) until system handover for Performance Qualification (PQ).
• Responsible for project planning scheduling and resource allocation.
• Writing executing and compiling various C&Q protocols and reports (e.g. IQ/OQ protocols). 
• Reviewing and updating URS specifications and other documents to ensure requirements are testable.
• Managing the Requirements Traceability Matrix (RTM) to ensure every user requirement has been tested and verified.
• Performing system Safe to Start reviews before energization.
• Troubleshooting and resolving any technical issues that arise during C&Q activities.
• Preparing and executing pre-commissioning and commissioning checklists.
• Acting as a central coordinator communicating with various parties such as design engineers end-users contractors and equipment vendors to ensure C&Q activities are completed on time and Right First Time.
• Attending project meetings and reporting on progress.
• Ensuring all activities adhere to company and industry Qualification standards.
• Supporting the change management process to ensure all changes are properly documented.
• Reviewing C&Q documents provided by contractors.

• 从项目最初的用户需求标准URS开始介入贯穿工厂验收测试FAT现场验收测试SAT安装确认IQ运行确认OQ直到将系统移交给性能确认PQ
• 负责项目的计划调度和资源安排
• 编写执行和汇编 各种C&Q协议和报告如IQ/OQ协议这是证明合规性的关键证据
• 审查和更新URS技术规格书等文件确保其中的要求是可测试的
• 管理需求追溯矩阵RTM确保每个用户需求都得到了测试和验证
• 执行系统的安全启动审查
• 解决在C&Q过程中出现的任何技术问题
• 执行预调试和调试检查清单
• 作为核心协调人与设计工程师用户承包商设备供应商等多方进行沟通确保C&Q活动按时高质量地完成即一次做对
• 参加项目会议汇报进展
• 确保所有活动都遵循公司和行业的Qualification标准
• 支持变更管理流程确保所有变更都被妥善记录
• 审查承包商提供的C&Q文件

Qualifications :

• At least 5 years of hands-on C&Q Experience: Must have first-hand experience in executing IQ/OQ and other qualification processes.
• Solid Engineering Knowledge: Familiarity with pharmaceutical industry facilities utilities (e.g. purified water HVAC) and production/packaging equipment.
• GMP Knowledge: Deep understanding of GMP regulations regarding equipment and system validation.
• Documentation Skills: Ability to write clear precise and compliant technical documents.
• Problem-Solving Ability: Capable of quickly diagnosing and resolving issues during commissioning.
• Excellent Communication and Coordination Skills: Ability to work effectively with people from diverse backgrounds.
• Detail-Oriented: In a highly regulated industry every detail is critical.
• Project Management Skills: Ability to plan tasks manage time and allocate resources.
• Team Player Mentality.

• 至少5年C&Q实战经验 必须有亲手执行过IQ/OQ等流程的经验
• 扎实的工程知识 熟悉制药行业的设施公用系统如纯化水 HVAC和生产/包装设备
• GMP知识 深刻理解GMP法规对设备和系统验证的要求
• 文件撰写能力 能够撰写清晰准确合规的技术文件
• 问题解决能力 能够快速诊断和解决调试过程中出现的故障
• 卓越的沟通与协调能力 需要与不同背景的人有效合作
• 注重细节 在高度规范的行业中任何细节都至关重要
• 项目管理能力 能够规划任务管理时间和资源
• 团队合作精神

Additional Information :

Our inspired people share our vision and mission. We provide a great place to work where each person has the opportunity and voice to affect change.

We want our people to succeed both in work and life. To support this we promote a healthy productive and flexible working environment that respects work-life balance. 

Turner & Townsend is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees and actively encourage applications from all sectors of the community.

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Any unsolicited resumes/CVs submitted through our website or to Turner & Townsend personal e-mail accounts are considered property of Turner & Townsend and are not subject to payment of agency order to be an authorised Recruitment Agency/Search Firm for Turner & Townsend there must be a formal written agreement in place and the agency must be invited by the Recruitment Team to submit candidates for review. 

Remote Work :

No

Employment Type :

Full-time