Engineering Manager - Chapel Hill, United States - CARsgen Therapeutics

Description

Engineering Manager

Position Summary:

The Engineering Manager provides support for the ongoing growth of operations at the CARsgen Therapeutics Research Triangle Park (RPT), NC facilities.

The Engineering Manager will oversee and coordinate the daily operations of engineering staff while ensuring that company objectives and goals are met.

The position will focus on facility, cleanroom, process equipment and analytical equipment support and continuous improvement. A key component will be ownership of the computerized maintenance management system (CMMS) and environmental monitoring system (EMS). The Engineering Manager will own small to medium capital projects as required in the facility.

This is a key role in the site leadership team for ongoing GMP operations in a clinical batch manufacturing facility.

It is anticipated as the company develops more manufacturing capacity this position will help with the planning, design, and construction phases of the project.

This Engineering Manager must be able to operate under minimal supervision at the companys facility in RTP, NC (onsite, not remote).

This position will report to the Director of Engineering. This role is in the biotech industry and experience in biotech/pharmaceutical/cGMP is required.

Key Responsibilities:
Recruits, interviews, hires, and trains new engineering staff.
Oversees the daily workflow of the department.
Efficiently manage projects minimizing the cost to CARsgen to accurately complete the project while achieving the objectives.
Successfully managing contractors and service suppliers on one or more projects of various sizes, as required.
Participate in the development of all major technical, cost, scheduling, and performance decisions on assigned projects.
Development of the engineering department capabilities and processes to support biotech clinical trial and commercial manufacturing operations


This may include:
o Facility and process maintenance team (preventive maintenance and work order program, pest control, utility maintenance including boilers, air handlers, compressed air, chilled water, refrigerators, freezers, incubators, bioreactors)
o Instrument calibration program
o Engineering drawing and project management program
o Engineering procedure (SOP) development
o Development of service provider contracts
Leading the effort in building a productive team both within CARsgen and with the service and equipment suppliers.
Maintaining timely and accurate reporting including weekly and monthly reports utilizing a comprehensive action item list.

Qualifications & Requirements:
Bachelor or Master of Science degree in Mechanical, Electrical, Chemical or Civil Engineering from an accredited university is preferred.
Professional Engineering and/or Project Management Professional (PMP) registration is desired but not required.
This position requires 5+ years of relevant experience in engineering and manufacturing operations support. Strong experience with GMP, Biotechnology, and/or Pharmaceutical

Experience with a CMMS system (such as Blue Mountain RAM), a BMS system (such as Trane Tracer), and a cleanroom EMS (such as Vaisala Viewlinc) is required.

Knowledge and application of company business standards and good practices.
Knowledge and application of company engineering standards and project controls tools.
Ability to lead a team to deliver on commitments.
Experience with GMP change controls, deviations/investigations, and CAPA programs.
Ability to manage contractor relationships in complex situations.

Ability to relate easily to others in the business community such as customers, suppliers, contractors, government, professional, and trade associations.

Ability to handle stress with poise.
Ability to delegate authority appropriately.
Ability to clearly communicate expectations and requirements to team members and to structure accountability.
Ability to set priorities.
Demonstrated leadership ability with team orientation.
Coaching and mentoring skills and experience.
Excellent listening and communication skills, both verbal and written.
Excellent presentation skills.
Excellent leadership and organizational skills.
Proficient in the use of Microsoft Office tools.

#J-18808-Ljbffr