[외국계제약유통기업] Facilty Maintenance Specialist

[공고용]

[외국계기업] FACILITY MAINTENANCE Specialist

[회사소개]

외국계 기업 (의약품 유통판매 자회사)

[채용조건]

근무지: 경기도 용인

근무시간: 09:00 ~ 18:00

고용형태: 정규직

직급, 연봉: 면접 후 협의

[업무내용]

[ROLES AND RESPONSIBILITIES]

1. Facility & Equipment Management

 Perform on going preventive maintenance and repair work on facility mechanical, electrical, and other installed systems.
 Maintain Facility & Equipment Control: Maintains, operates all Temperature & Humidity Control systems and associated equipment, and monitor the building management system.
 Monitoring and Maintenance: Regularly monitor and maintain the auto-recording system and depot facilities (electricity, water supply, LN tank, fire prevention facilities, air circulation in the warehouse, security system, and all aspects of building management).
 Respond to emergencies: serving as the primary contact for all facility related emergencies (Including but not limited to fire alarms, BMS system alarms, security alarms, etc). Includes monitoring and responding to building security/fire system alarms which may require work even during off work hours, weekends and holidays;
 Calibration Process: Follow up on the calibration process for all devices requiring calibration.
 Regularly check housekeeping devices and identify risk factors in facilities.
 Ensure pest control measures are followed regularly.
 Report facility and security issues to the Operations Manager and propose countermeasures.

2. Cold Chain Management

 Cold Chain Equipment Monitoring: Regularly monitor and maintain cold chain equipment to ensure optimal performance.
 Temperature Excursion Response: Quickly and effectively respond to any temperature excursions, ensuring the integrity of temperature-sensitive materials.  Compliance: Ensure all cold chain processes comply with regulatory standards and internal SOPs.

3. Validation

 Prepare and maintain relevant validation documents (IQ, OQ, PQ, VMP, VMS).
 Oversee the validation process for all equipment and processes, ensuring they adhere to company and regulatory standards.
 Conduct validation for shippers, storage, and transportation vehicles to ensure they meet regulatory and performance standards.

4. Other Responsibilities

 Change and Deviation Control: Facilitate the process of change control and deviation control, coordinating these issues with principals and the QA team.
 Expense control: Assist in budget preparation and ensure it is followed.
 Audit Preparation: Perform audit preparation tasks as requested by the QA and Operations Manager
 Support any afterhours building needs and activities as required

 [지원자격]

Minimum of 5 years of experience in facility maintenance within a GMP-regulated environment (Extensive experience is preferred)
 Certification in GMP (e.g., Certified Pharmaceutical GMP Professional (CPGP), Certified Quality Engineer (CQE), or equivalent) is highly desirable
 Strong understanding of GMP standards and regulatory requirements
 Proficiency in English is required
 Excellent problem-solving and organizational skills
 Ability to work independently and within a team environment
 Strong communication and interpersonal skills
 Relevant certifications in facility management, such as plumbing maintenance, electrical maintenance, and HVAC, are advantageous but not mandatory (Preferred)
 Experience in setting up new depots or facility is preferred
 Proficiency in using facility management software and tool (Preferred) 

[키워드]

제약 / GMP / CPGP / CQE