暖通工程师（Contractor)

1.5-2万·13薪

上海浦东新区
10年以上
本科
全职
招1人

暖通设计暖通运维给排水工程空调工程净水初级暖通工程师职称中级暖通工程师职称高级暖通工程师职称无菌灌装BMS/EMS医药行业经验

职位：暖通工程师
地点：张江
Contractor长期

Greenfield project delivery and
Routine Operation.
Strategic project realization
including Facility & Utility design, commissioning, qualification,
operation readiness and start up.
Ensure a close collaboration
with the site and project organization to ensure Roche business goals,
responsible for the following activities:
1) Facility management
including site facility & utility operation(7*24h), Third party
service mgnt, GMP and ambient room, cold room; Pest Control, Clean
Finish, Laundry Service etc
2) HVAC equipment for DP,
Warehouse, and QC, Automation & Controls (BMS, EMS, SCADA, PLC), etc,
3) Clean Utilities including
Purified Water, WFI, Clean Steam, Process Air, Special Gas etc.
4) Black utilities including Potable water, Compressed
Air, chiller, cooling water system. Wastewater Treatment
(WWTP)Demonstrate leadership behavior and mindset.

Act as the
Facility & Utility Engineer representative on the project team,
contributing to design, construction, and qualification activities. This
includes reviewing URS (User Requirement Specification), and executing
FAT, SAT, and IOPQ to contribute to project delivery.
Lead or act as facility and
utility maintenance team coordinating with Engineering department,
production department, quality department, vendors, etc for cooperation
to achieve the positive goal.
Establish and develop facility
and utility maintenance operation system in alignment with the Roche
standards including maintenance management system, people training and
qualification, CCS strategy and implementation to support robust
operation readiness.
Support manager to develop a
competent team through coaching, mentoring and training by having in
place a skill competencies development and appraisal program to
strengthen the technical expertise and capabilities.
Participate in tech transfer,
collaboration with other functions to ensure the success of new product
manufacturing.
Represents the facility and utility during regulatory
inspections and audits and participates in the response of regulator
audit and global quality audit.

System
Ownership:

Take full accountability for
the operation and maintenance of Facility & Utility systems,
ensuring all activities comply with Roche’s GMP/EHS standards and
regulatory guidelines.
Work as a Sterilization
aseptic expert to provide technical support in Facility & Utility
aspects.
On call for system emergent
complex trouble shooting escalated from technicians.
Ensure that all relevant
information relating to activities within your scope is tracked,
captured and forwarded in due time to your manager or the head of
department.
Establish and maintain a
strategic and technical roadmap for the responsible area to support the
site's strategic development and product lifecycle.

Maintenance Execution:

Plan and execute preventive
and corrective maintenance programs to maximize equipment availability
and optimize life-cycle costs.
Enhance Facility & Utility
system maintenance and operation through implementation of an effective
maintenance and operation program, work prioritization, complying with
operational and personnel standards, regulatory and statutory
requirement to ensure efficient, reliable, and uninterrupted plant
operation.
Propose spare parts for
responsible equipment and control the cost within budget.

Compliance:

Ensure audit readiness by
adhering to cGMP, regulatory, and statutory requirements to protect
product quality and prevent compliance observations.
Represent the Facility &
Utility systems during regulatory inspections and audits.
Responsible for the Quality
and Accuracy of data and records of relevant equipment and maintenance.

Troubleshooting &
Improvement:

Respond to critical alarms,
lead deviation investigations, execute CAPAs, PE and provide timely
technical support for complex issues.
Drive continuous improvement
initiatives to enhance sustainability, safety, and asset reliability.
Ensure in time response to
critical alarms in compliance with the SOP and related Quality
Procedures.
Evaluate the alarm trends and
establish corrective actions to avoid repeat events.

Assets Lifecycle Management
& Reliability:

Evaluate the system capacity
and provide related Operational & Maintenance data for project
initiation.
As the Facility & Utility
system owner and SME, actively participate in the design, review,
comment, commissioning and handover of site new projects according to
Site CAPEX process.
Responsible for the
implementation of the site Reliability Engineering process within owned
areas.

Sustainability: Support to
drive continuous improvement by providing recommendations and initiative
to promote sustainability (Energy & Water), safety, maximizing asset
reliability and operational performance to drive operation excellence in
utilities operation to achieve financial objectives to gain cost
competitiveness.
Documentation: Maintain accurate and timely records of
all equipment and maintenance data. Draft and/or review SOPs and other
relevant documentation.

Bachelor’s
degree or above in HVAC, Mechanical-Electronic Engineering, Mechanical
Engineering, Chemical Engineering or a related field.
Familiarity with relevant local
regulations and authorities (e.g., NMPA).
Special Equipment management
certification is a plus.
Minimum 8 years of facility and
utility management or engineering experience within the injection
pharmaceutical industry, MNC Bio-pharma preferred, with a strong
preference for experience in a GMP environment.
HVAC (Heating, Ventilation, and
Air Conditioning), Clean Utilities (PW, WFI, CS, PA), Electrical Systems,
Automation & Controls (BMS, EMS, SCADA, PLC), Wastewater Treatment
(WWTP)
Proven experience in strategic
projects for Aseptic Filling facilities, including design, commissioning,
and qualification.
Experienced in new facility
startup readiness and operation ramp-up.
Fluent in written and spoken
English, with strong collaboration skills to effectively work with
diverse teams and stakeholders.
Able to think strategically and
translate strategies into actionable plans, understand and apply agile
ways of working
Experience with BMS/BAS
(Building Management/Automation Systems) and related software.
Experience with Lean
Manufacturing or Six Sigma methodologies.
PMP or other project management certifications.

浦东新区上海罗氏制药有限公司(西北门)

入职公司某大型公司

公司地址上海静安区

公司人数 100-299人

公司介绍

上海东浩人力资源有限公司隶属于上海外服(集团)有限公司，在长三角、大湾区、京津冀、中西部建立大区招聘中心，不断推动外服全国招聘能力高质量发展。同时结合外服集团逾38年的行业及细分领域深耕，为客户提供具备地域、产业特征的行业人才招聘及用工服务方案。位于中国武汉的全国人才寻访中心，通过AI顾问与人工顾问以”技术赋能+专业服务”的模式，执行全国大批量项目，为外服各招聘团队提供高效专业的支持。