Senior Process Engineer
About Biopharmaceutical Contract Manufacturing
Boehringer Ingelheim aims to become China's first international provider of biopharmaceutical contract manufacturing solutions with all-round services to its clients in China and all over the world. As the leader in biopharma CMO manufacturing, Boehringer Ingelheim introduces innovative business models into China to further promote development of China's biopharma industry, boosting global competitiveness of Chinese biopharma companies, and facilitating clinical research and market launch of China's innovative medicines in a bid to accelerate growth of China's bio-technology industry. The Company's state-of-the-art production platform, management system and global biopharma network will help bio-medicines made by Chinese companies to enter the global markets.
Responsibilities
1) Operations & Compliance
- Take overall responsibility for the day‑to‑day operation and technical management of GMP‑related facilities (HVAC, cleanroom air systems, cold storage, and supply chain warehousing facilities), ensuring stable, reliable, and sustainable support to manufacturing.
- Ensure systems comply with EU/FDA/China GMP and the company’s global and local quality systems.
- Serve as the Subject Matter Expert (SME) to participate in and oversee change control, deviation investigations, and CAPA, ensuring risks are controlled and evidence is closed in a compliant manner.
- As SME, support and participate in internal and external audits, prepare and respond to audit queries, and drive remediation as well as compliance/quality upgrades.
2) System Management
- Manage the technical health of cleanroom HVAC (including pressure cascades, airflow/velocity, temperature & humidity, filtration and integrity) and cold storage facilities (temperature control, alarms), ensuring continuous environmental compliance.
- Monitor and leverage data from EMS/SCADA/BMS and related control systems to perform equipment performance analysis, alarm management, and parameter optimization, establishing a closed‑loop control across process–facility–monitoring.
- Continuously monitor environmental and system KPIs (temperature/humidity, pressure differentials, particulates, microbiology, energy consumption, alarm rate), and drive energy efficiency optimization and reliability improvements (e.g., filter media upgrades, control strategy optimization).
- Apply root‑cause methodologies (5 Whys/Fishbone/FMEA), develop improvement roadmaps, and track benefits realization.
- Lead or participate in local and global engineering changes, system upgrades, and automation initiatives (e.g., building/environmental monitoring, energy efficiency and decarbonization solutions), delivering within budget, schedule, and quality constraints.
- Act as SME to support URS/DQ/IQ/OQ/PQ and validation strategies; author/maintain SOPs, WIs, drawings, and technical documentation, and organize user training and technical handovers.
3) Maintenance & Calibration
- Develop and execute Preventive Maintenance (PM), Predictive Maintenance (PdM), and calibration plans; manage work orders, asset registers, lifecycle, and critical spare parts via CMMS.
- Coordinate planned shutdown maintenance and emergency repairs with internal teams and external service providers; conduct equipment failure analysis and deviation/discrepancy investigations; implement appropriate CAPA to optimize equipment performance and improve availability and stability.
4) Capex & Opex
- Based on business and capacity plans, assess, initiate, implement, and hand over Capex projects related to process/HVAC/cold storage; exercise end‑to‑end control over cost, milestones, scope, and quality.
- Orchestrate design, procurement, construction, and commissioning; perform technical clarifications, control site changes, and complete as‑built documentation archiving.
- As the HVAC SME, own financial oversight and cost control for assigned projects and system operations (budgeting, cost accounting, energy‑saving and cost‑reduction).
5) Cross‑Functional Collaboration & Vendor Management
- Collaborate effectively with Production, Quality, EHS, Supply Chain, Validation/QA, etc., to support businesses including new product/process introductions.
- Manage the technical capability and performance （KPI/SLA） of external engineering service providers and key equipment suppliers; organize audits and technical reviews to ensure compliant delivery.
- Serve as the local HVAC SME in global regular meetings, maintain strong communication across company networks, and provide professional technical support.
Qualifications
- 5+ years of experience in the biopharmaceutical industry, covering process/HVAC/cleanroom engineering equipment technical support as well as project planning and design.
- Bachelor's or Master's degree in Mechanical Engineering, Process Engineering, or a related discipline (or equivalent education).
- Proven experience in equipment maintenance and operations; solid knowledge of occupational safety and GMP.
- Proficient with SAP, Microsoft Office, and database tools.
- Demonstrated proactivity and flexibility, strong planning and organizational skills, and the ability to work goal‑oriented and independently.
- Strong English skills (both spoken and written); effective collaboration across local and global teams; confident, proactive, and results‑driven.
- Customer‑focused with excellent teamwork capabilities.