Jobid=5394eea91d06 (0.0325)
Our client is a leading Project Management and Engineering company serving the pharmaceuticals industry around the world.
Duties, Summary of Role:
Under the direction of Engineering manager, the HVAC & Process Utility Engineer will:
- Closely work with Facility Management (FM) team on the clean room HVAC and process utility (clean nitrogen and purified water system), manage Environmental Management System (EMS) system accordioning to SOP, GMP and relevant regulations, to ensure reliable HVAC & Process Utility to support the business operation.
- Support utility capacity planning, construction, and maintenance of equipment.
Key Responsibilities:
- Serve as the HVAC SME and closely work with FM team for daily operations support, manage the risk and mitigation plan for the clean room HVAC, process utility and EMS, support routine PM program, conduct regular inspections to ensure all those systems are functioning optimally, have reliability and stable performance, meet the requirement of regulatory standards.
- Monitor system performance through routine trending and data analysis to ensure environmental conditions consistently meet cleanroom requirements.
- Maintain up-to-date knowledge of global regulations, standards, and technological advances in HVAC to ensure site readiness and continuous compliance.
- Responsible for maintaining local procedure, work instructions, records and training materials for HVAC, process utility and EMS system operation.
- Manage spare parts inventory for clean room HVAC system, EMS, process utility system, ensuring that necessary components are readily available for PM and CM.
- Provide technical support during audits and regulatory inspections.
- Lead troubleshooting and root cause analysis for deviations, excursions, or performance issues, and implement corrective and preventive actions.
- Generates related non-conformances (NC) according to local procedures. Support NCs & CAPAs related to HVAC, process utility and EMS system.
- Support quality and EHS related audits to ensure that HVAC, process utility and EMS system audits are always ready
- Identify and implement continuous improvement initiatives to enhance system reliability, energy efficiency, and sustainability.
- Closely work with FM team on supplier management
- Monitor work progress and supplier’s performance.
- Maintain knowledge of current agreement for the development of proper relations with supplier.
- Manage contractors working on site performing maintenance and repairs.
- Follow all company safety policies and other safety precautions within the work area.
- Follow Records Management Policies for Convenience Information, Records Retention Schedules, Training.
- Follow GMP requirements.
- Work with the team to ensure all aspects of the business remain compliant and, in an audit, ready state.
- Responsible for communicating business-related issues or opportunities to the next management level
- Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Performs other duties assigned as needed
Requirements :Qualifications/Experience:
- Bachelor’s degree in engineering preferred, HVAC, Mechanical, Electrical, Electromechanical, Automation engineering majors preferred and 4 to 6 years of experience in related fields preferred.
- Bilingual: Fluency in English, Strong written and oral communication in English required. Second language Dutch preferred
- Experience in the Medical Device and/or pharmaceutical industry or medical field. Knowledge of GMP/ ISO 13485 preferred.
- Proven experience as an HVAC Engineer or similar role in HVAC systems operation.
- Excellent understanding of HVAC design, knowledge of relevant HVAC standards and codes.
- Knowledge of manufacturing principles and practices, and procedures preferred.
- Knowledge of information systems including but not limited to Environmental Management System (EMS), Building Management Systems (BMS) and Maximo is preferred.
- Capable to interpret the vendor maintenance/calibration/qualification reports to verify the effectiveness of the vendor’s work and adopt the outcomes into the process.
- Troubleshooting and problem solving.
- Knowledge of word processing, spreadsheet analysis, data management.
- Proper communication skills; making complex issues easy for others to understand when acting as a core team member in projects.
- Ability to work cooperatively with internal and external stakeholders
- Ability to build strong working partnerships, trust and credibility at all levels
- Organizational, collaboration, communication and leadership skills
What do you get?
- Pension entitlement (15.9% employer contribution, 7.5% employee contribution)
- Collective WGA / WIA insurance
- NBBU collective labour agreement through equal remuneration
- 25 holidays days
- 8% holiday allowance
- 100% payment in case of illness after one waiting day
- Travel allowance per kilometer or through public transport
Deel deze vacature: