DESCRIPTION

The Cleanroom Contamination Control SME will complete the principal duties and responsibilities outlined below. Working in collaboration with leadership and senior staff, the SME will develop critical cleanroom contamination control strategies. Activities may include cleaning validation, disinfectant efficacy testing, contamination control material selection and validation, process improvement identification and implementation, vendor evaluation, 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 Contamination Control SME include at a minimum:

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

·       Provides critical content for the Contamination Control Strategy (CCS). Participates in cross-functional periodic evaluation and revision of the CCS.

·       Leads Contamination Control Committee.

·       Performs gap analyses to identify areas of opportunity to improve contamination control measures.

·       Implements proactive steps to mitigate introduction and / or retention of contaminants in critical cleanroom spaces.

·       Identify, evaluate, and validate critical contamination control materials including but not limited to: antimicrobial chemical agents, cleanroom wipes / mops / tools, and gowning.

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

·       Participates in investigations of quality events.

·       Serves as technical expert during audits and inspections. 

·       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.

·       Has a comprehensive working knowledge and understanding of contamination control strategies.

·       Experience with cleaning validation is desired.

·       Experience with disinfectant efficacy testing is desired.

·       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

Andelyn Biosciences is currently operating under Executive Order 14042 that requires that employees of federal contractors and its affiliates be vaccinated against COVID-19, with some limited exemptions under the law.  As Andelyn is both an affiliate and will be a federal contractor, proof of vaccination status will be required prior to first date of employment.  Religious and medical exemptions may be considered depending upon the specific job duties and in accordance with applicable federal guidelines.