DESCRIPTION

The Cleanroom Engineering SME will complete the principal duties and responsibilities outlined below. Working in collaboration with leadership and senior staff, the SME will lead critical cleanroom facility design and engineering activities. Activities may include facility design review / qualification, participation in facility commissioning and qualification program, process improvement identification and implementation, vendor evaluation, coordination of vendors, management of project timelines / tasks, authoring / reviewing technical and procedural documents, as well mentoring junior staff. The SME will support efforts to deliver all products in a timely, compliant, and fiscally responsible fashion.    

Schedule: Full-time (Benefits Eligible) 

Location: 

Central Campus 

700 Children's Drive

Columbus, OH 43205 

 

Under the guidance and direction of the Facility Manager/Supervisor, essential functions of the Cleaning Room SME include at a minimum:

·       Rapidly develop sufficient expertise to function independently with minimal supervision.

·       Attends and participates in design, construction, commissioning, qualification, and other meetings as required.

·       Develops a comprehensive working knowledge and understanding of facility design documents.

·       Serving as technical expert during facility design review / design qualification, providing critical feedback to leadership to drive design changes as needed.  

·       Author / revise / review GMP documentation related to facility operation and associated engineering practices – documentation may include, but is not limited to, standard operating procedures, work instructions, technical protocols, technical reports.

·       Coordinate with vendors / contractors to schedule and execute routine preventative maintenance on cleanroom HVAC and control systems.

·       Anticipating problems and removing obstacles to enable staff to perform tasks as assigned.

·       Work toward broad goals for area of responsibility.

·       Have significant latitude for making decisions for their operational or functional unit.

·       Exercise crucial people skills.

·       Ability to manage and influence people in direct or lateral support structure.

·       Work to specific measurable objectives requiring operational planning skill with little direct supervision while driving timelines through broad influence.

·       Cultivate a diverse and collaborative team environment. Utilizes clear and concise communication to deliver high productivity and contribution to the success of department goals.

·       Attention to detail in all job functions.

·       Developing and enforcing procedures and controls.

·       Mentoring and professional development of staff.

·       Performs in accordance with established policies, procedures, and techniques and requires training common experience or working knowledge related to the tasks performed.

·       Has budgetary responsibility.

·       Responsible for hiring, development and related personnel processes.

·       Drives timelines and development through broad influence.

·       Make decisions based on established procedures.

·       Demonstrate high level of integrity.

·       Operate within the Quality Management System applicable to the manufacture of phase appropriate material in the CMF.

·       Maintain compliance with applicable regulatory requirements for cellular and gene therapy products.

·       Maintain positive attitude.

·       Other duties as assigned.

 

Knowledge, Skills and Abilities required

·       Requires a relevant four-year degree with at least eight years of relevant experience; or relevant masters and four years of experience or relevant PhD with two years of relevant experience.

·       Understanding of GMP, GLP, or GEP is required

·       Understanding of HVAC systems and ability to work with outside contractors is required.

·       Working knowledge of cleanroom airflow principles is desired.

·       Experience with building management systems / building automation systems is desired.

·       Experience with facility commissioning and qualification preferred.

·       Experience with aseptic manufacturing cleanroom environments preferred or extensive experience in highly regulated field.

 

 Minimum Physical Requirements

·       There are very minimal physical requirements.  One needs to be able to lift 20-30 pounds occasionally (0-33% of the time).

·       May require ability to aseptically gown or wear other PPE on regular basis.

·       Must be able to stand for extended periods.                                                                               

 

EOE M/F/Disability/Vet