葫芦岛招聘

职位描述：
Description:
1. Manages all HVAC technology aspects of BioChina engineering across GMP facilities (USP, DSP, Fill & Finish and QC-Lab). Manages daily operations of HVAC systems & equipment, developing and performing Maintenance & Calibration activities, and all associated documentation, to ensure reliable uninterrupted supply to manufacturing whilst maintaining GMP and regulatory requirements:
2. Possesses excellent process & HVAC design knowledge; Acting as lead Engineer, implementing change initiatives through local and global expert input, including associated automation across the entire facility, to budget, time and all quality aspects.
3. Continuously improves inter-personnel skills to ensure the above three basic purposes are fulfilled. Capable to lead Internal & External engineering personnel to ensure reliable & efficient operations of HVAC within GMP BioPharma operations.
4. Provides technical support to process Engineering and process equipment in respects to fault finding / diagnostics, and repair.
 
Duties & Responsibilities:
1. Providing Engineering Excellence to User and Operator
-Proactively communicates equipment related bottlenecks or shortcomings to Planning / Engineering Manager in order to avoid lag times
-Prepare maintenance / calibration specifications for HVAC equipment, including specification of critical spare part management
-Manages / Coordinates / Executes maintenance / calibration activities for HVAC equipment in consultation with operation and other supporting functions
-Initiates, supervises and coordinates internal and external maintenance / calibration services for HVAC equipment
-Supports key users / supervisors regarding the design hook up of production equipment and associated maintenance schedules
-Develops and optimizes HVAC equipment for BI use
-Be responsible for the whole life cycle of process equipment, including SOP’s
-Be responsible for GMP-compliance of HVAC equipment and associated technical documentation (engineering part). Conduct -GMP related Deviations, Investigations, CAPA’s etc as required
-Ensures EHS compliance is maintained during normal running, and for equipment modifications and new equipment/facilities
-Ensures that all process and lab equipment, machinery, documentation (incl P&ID drawings, etc.) and technical support are compliant with the quality and EHS standards
-Provides overall knowledge of occupational safety and GMP requirements
 
2.Continuous Improvements
-Identify improvement potentials and implement all related measures
-Develops reliable and flexible biopharmaceutical HVAC equipment concepts
-Supports qualification activities
-Ensures availability and operational readiness of equipment and systems
-Leads and coordinates engineering partners on process topics
-Coordinates procurement, design, installation, commissioning activities of equipment and systems
-Provides financial overview and controlling of project scope during project lifetime
  
3. CapEx Project Planning
-Supports the Planning, cost calculations & implementation of investment for local and international projects
-Carries out GMP-compliant technical planning for pharmaceutical facilities in respect to HVAC
-Supports in developing system solutions up to commissioning, qualification and hand-over to the operator/end users

4. Engineering Design
-Coordinates and be responsible of all HVAC process design aspects
-Manages / Coordinates the procurement of HVAC equipment (technical specifications/URS, vendor search, technical clarification, FAT / SAT)
-Delivers technical support, project planning and design of process equipment in biopharmaceutical environments
-Interface coordination with other disciplines
 
5. Engineering Partner Evaluation & Selection
-Actively contributes to the evaluation of appropriate engineering partner for BI local and global CapEx projects
-Actively participates in BI negotiation about selection of right partners and all contractual matters
-Monitors and controls performance of selected engineering partners and other design institutes

Requirements:
-Work Experience for > 7 years
-Experience in technical support, project planning and design of process equipment in the biopharmaceutical environment
-Experience in maintenance & Calibration of HVAC process equipment in the biopharmaceutical environment
-Knowledge of occupational safety and GMP
-Experienced user of SAP and MS Office as well as data bases
-High level of initiative and flexibility
-Strong planning and organizational skills
-Targeted and autonomous working style
-Good English skills, both written and spoken
-Routine working with local teams, and collaboration with global experts as required
-Self-confident, self-motivate and results orientated
-Social competence, customer orientation and a good team player 举报 分享

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