Facilities and Engineering Manager, Sr.

Description

• Position Title: Facilities and Engineering Manager, Sr.
• Site : Houston, TX 
• Department: Facilities and Engineering
• Reports to: Chief Technology Officer
• 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 by a team of visionary scientists united by a common goal—to make life-changing gene therapies accessible to all. Witnessing the success of adeno-associated virus (AAV) vectors in restoring sight and hearing to patients, our team saw both the promise and the challenge: the high cost and complexity of vector production, which limited access to those who needed it most.

Determined to overcome these barriers, we built PackGene to revolutionize AAV manufacturing with innovative, scalable, and cost-effective solutions. Our work has enabled life-changing therapies, including a young boy born with congenital deafness. After receiving an AAV-based treatment produced by PackGene, he began responding to his family's voices. A few months later, he spoke his first word: “Dad.” His father wept with joy—a moment that reminded our team why we do what we do. It was more than just science; it was about restoring hope and giving families a future.

Today, PackGene is a global leader, serving clients in over 30 countries and partnering with more than 1,000 biopharmaceutical companies and research institutions. Our slogan, "Make Gene Therapy Affordable," reflects our unwavering mission. We focus on tackling key challenges in gene therapy development, including viral vector production and specific targeting, mRNA technologies, and GMP production at scale. We are committed to providing stable, qualified, cost-efficient, and fast services, along with technical support, to empower our gene therapy partners. Together, we aim to transform lives and build a healthier, better world.

PackGene is seeking a highly motivated individual with FDA regulation and current Good Manufacturing Practice (cGMP) knowledge for the role of Facilities & Engineering Manager, Sr. The Facilities and Engineering, Manager, Sr. 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 10-14+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
• Vendor management experience
• Support some IT functions
• 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 2lbs 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:

Facilites Tech