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.