Senior BMS/EMS engineer

Job Description:

We are looking for a BMS/EMS Design Engineer to join our global engineering team as the owner’s technical representative for greenfield and brownfield bio-pharmaceutical projects. In this capacity, you will take the lead in defining user requirements, developing Conceptual Design (CD) deliverables, and managing external design institutes and A/E firms through the BOD/ DD phase. Your primary mission is to ensure that all BMS/EMS solutions are fully aligned with GMP, GAMP5, and 21 CFR Part 11 standards, while protecting the owner’s long-term operational and compliance interests.

The core focus of the role is to develop Design Package from Concept Design to Detail design and support project daily design work, including but not limited to Develop the Design Packages, Design Coordination, Design Management, Communication with WuXi Biologics Internal and/or External Ender Users / Design Firm / Consultant, Project Professional Consultants, and etc.

You will work at the intersection of HVAC control, utilities automation and regulatory compliance, delivering solutions that maintain stringent environmental conditions for cleanrooms, stability chambers, and laboratories

Key Roles and Responsibilities:

Concept Design (CD) Phase

1． Define and document the overall BMS/EMS architecture, control philosophy, and system segmentation at the conceptual level.

2． Develop User Requirement Specifications (URS) and System Level Functional Specifications that clearly articulate performance criteria for cleanroom environmental control (temperature, humidity, differential pressure), cold storage monitoring, and laboratory stability chambers.

3． Establish the owner’s design basis, including preferred BMS platforms, communication protocols (BACnet, Modbus, OPC, Profinet), and data integrity requirements per 21 CFR Part 11.

4． Prepare preliminary network topologies, control loop strategies, and high-level point counts to support cost estimation and project budgeting.

Detailed Design (DD) Phase

5． Act as the technical gatekeeper during the DD phase, reviewing and approving all deliverables from design institutes and engineering contractors, including:

l Detailed IO lists, point schedules, and instrument datasheets;

l Cable schedule, cabinet and instrument layout

l Detailed network architecture;

l Sequence of Operations (SOO) and control logic descriptions;

l BMS/EMS server, database, and client workstation configurations.

6． Provide design review comments and ensure that contractor designs meet URS and CD basis.

7． Challenge design decisions from a long-term operability, maintainability, cost effectiveness and regulatory inspection-readiness perspective.

Cross-Discipline Coordination & Interface Management

8． Coordinate with internal stakeholders (Process, Mechanical, AIS, QA, SEM) to ensure BMS/EMS design interfaces seamlessly with PLC/DCS/DDC, electrical power distribution, and building utilities.

9． Manage the interface between the BMS/EMS and third-party equipment vendors (e.g., chillers, air handlers, TCUs) to ensure proper communication and control integration.

10． Facilitate technical workshops with design institutes and contractors to resolve design clashes and optimize system performance.

Compliance & Validation Support

11． Ensure all design deliverables are produced in accordance with GAMP5 lifecycle approach, with clear traceability from URS through to design specifications.

12． Support the development of the Validation Master Plan (VMP) by providing design-level input for FS/HDS/SDS/IQ/OQ/PQ protocols.

13． Prepare technical documentation for regulatory submissions and inspections (e.g., NMPA, FDA, EMA).

Project Technical Governance

14． Establish and maintain the owner’s BMS/EMS design standards, templates, and lessons-learned database for use across multiple projects.

15． Support procurement activities by reviewing technical bid packages, conducting vendor technical evaluations, and participating in FAT/SAT together with contractors if needed.

16． Monitor design progress against project milestones and provide early warnings for any technical risks or scope deviations.

Key Skills Required:

1． Bachelor’s degree or above in Automation, Control Engineering, Electrical Engineering, or related discipline.

2． Minimum 15 years of experience in BMS/EMS system engineering, with at least 5 years working on the owner’s side or in an EPCM consultancy delivering pharmaceutical/life sciences projects.

3． Proficient in clean room HVAC, BU and clean room control logic. Platform Knowledge: Hands-on familiarity with major BMS platforms (e.g., Rockwell FactoryTalk, Siemens Desigo/WinCC, Schneider EcoStruxure, Honeywell) – sufficient to critique and guide contractor designs without necessarily operating the software daily. Protocols: Deep understanding of BACnet, Modbus, OPC, and industrial Ethernet protocols for system integration.

4． Prefer to be familiar with mainstream Hyper-Converged Infrastructure (HCI) architectures and VMware virtual server environments.

5． Familiar with GMP, GAMP5, and FDA 21 CFR Part 11 – able to interpret regulatory requirements into concrete design specifications.

6． Must have design experience from Conceptual Design to Support During Construction (SDC) for Oversea projects or Local International Pharmaceutical Projects.

7． Working knowledge of AutoCAD/Revit MEP for drawing review purposes; proficiency in MS Office and project collaboration tools.

8． Fluent in English (both written and spoken), Oversea Work Experience is preferred.

9． Must be Proactive, Determination, Self-motivated, have Ownership, and Strong Anti-pressure Capability.

10． Be able to re-lo to the project in China or oversea if needed.

Procurement and Project Execution

1． Package owner role incl. prepare URS & tendering spec, organize technical bid analysis, review/approve vendor design, manage installation & commissioning.