Location: Houston, Texas
Department: Facilities and Operations
Reports To: Associate Director, Manufacturing
FLSA Status: Full Time/Exempt

Job purpose:

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.

Duties and Responsibilities:

• 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

Skills and 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

Working conditions:

• In Office

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: Extending hand(s) and arm(s) in any direction.
• Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers.
• Sitting: Sitting for a period of time.
• Standing: Remaining upright on the feet, particularly for sustained periods of time.
• Stooping: Bending body downward and forward by bending spine at the waist.
• Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly.
• Walking: Moving about on foot to accomplish tasks, particularly for long distances or moving from one work site to another.
• The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.

Direct Reports: None

Interested applicants should apply Here.