Facilities and Engineering, Supervisor, Manager or Sr. Manager

Description

Position Title: Facilities and Engineering, Supervisor, Manager or Sr. Manager

Site : Houston, TX

Department: Manufacturing

Reports to: Associate Director, Manufacturing

FLSA Status: Full Time/Exempt

Mission Statement

The mission of PackGene Biotech is to accelerate gene therapy product development by providing an integrated one-stop solution including plasmid, viral vector, fill-finish and QC analytical services for the gene therapy industry.

Company Background

PackGene Biotech was founded in 2014 and headquartered in Guangzhou China. It provides CRO/CDMO services to the emerging gene therapy industry and research institutes. Packgene Biotech (US) is a full subsidiary of the parent company and is expanding its global footprint to Houston TX.  

PackGene is seeking a highly motivated individual with FDA regulation and current Good Manufacturing Practice (cGMP) knowledge for the role of Supervisor/Manager/ Sr. Manager of Facilities & Engineering. The Facilities and Engineering, Manager is responsible for facilities, utilities day to day operations, equipment preventative maintenance, repairs, maintenance activities and site safety program. This candidate plays a key role in cGMP manufacturing at the PackGene Houston site.  

Requirements

Role Description 

• Manages day to day Facilities and Engineering activities of the new Gene therapy manufacturing cGMP facility including GMP cleanrooms and laboratories. 
• Responsible for facility and equipment lifecycle management, including installation, calibration, qualification, preventive maintenance, and repair.  
• Develop and maintain spare parts list and develop an appropriate inventory of spare parts.
• Develop and maintain a calibration and preventive maintenance program 
• Responsible for utility systems at the site, including HVAC system, Waste treatment system, and process gas system.
• Participate in site inspections from regulatory agencies and customers
• Responsible for managing a budget for facility maintenance, equipment calibration and PM.
• Participate in facility and utility related deviations, CAPA and change controls.
• Lead facility risk assessment, such as FMEA; being proactive to facility and equipment related risks and recommend mitigations. 
• Strong problem-solving abilities and drive for success 
• Point of contract with vendors and contractor to ensure services such as calibrations are performed on time 
• Maintain accurate records within an MRO (Maintenance Repair and Operations) system
• Act as the site Safety Health and Environment manager, develop and maintain safety programs
• Maintain pest control program at the site
• Other duties as assigned 

Qualifications

• Bachelor’s degree in engineering or related technical field with 5+ years in the biotech and / Or pharmaceutical industry. 
• Prior knowledge of cGMP and GLP preferred. Proficient in US FDA and EMA regulations and ICH guidance’s. 
• Experience with new cGMP facility start-up is a plus
• Strong knowledge in cleanroom operations, common utility systems in biotech industry, and equipment calibration and PM requirements. 
• Strong project management and interpersonal skills. 
• Cross-functional leadership 
• Ability to drive safety, quality, functional, technical, and operational excellence
• Proficient is MS suite of products and other engineering software required
• Working knowledge of risk assessment tools such as FMEA, failure mode and effect analysis.
• Familiarity with an electronic MRO System

Work Conditions:

• Onsite

Physical Requirements:

• Crouching: Bending the body downward and forward by bending leg and spine.
• Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction and having the ability to receive detailed information through oral communication and making fine discriminations in sound.
• Kneeling: Bending legs at knee to come to a rest on knee or knees.
• Lifting: Raising objects of 50lbs from a lower to a higher position or moving objects horizontally from position to position. This factor is important if it occurs to a considerable degree and requires the substantial use of the upper extremities and back muscles.
• Pulling: Using upper extremities to exert force in order to draw, drag, haul or tug objects in a sustained motion.
• Pushing: Using upper extremities to press against something with steady force in order to thrust forward, downward or outward.
• Reaching