Group Lead, Biotech Clean Room

Location
Sarasota, FL
Posted
May 06, 2022
Required Education
Masters Degree/MBA
Position Type
Full time
Akron Biotech is continuing to transform and further its rapidly growing capabilities and is now seeking highly motivated professionals to join our expanding team. This is an exciting opportunity to play a critical role within our organization that is driving advanced therapy development and commercialization with high quality industrial scale solutions. We manufacture and distribute components and raw materials for cell therapy discovery, development, and commercialization to meet industry needs worldwide. We offer an array of highly competitive benefits and perks to our valued associates.

General Responsibilities
Lead the cleaning crew performance and technique. Control any cleaning accessories and materials inventories.
Maintain GMP suites related SOPs: Cleaning, gowning, material flow, personnel flow, change over, line clearance, etc.
Coordinate schedule for routine cleaning, major cleaning, cleaning supplies, gowning supplies and any other operation related with the functionality of the clean room.
Interact with others department (QC, QA, supply chain, MFG, etc) to overcome challenges and guarantee clean room readiness. EXAMPLES: QC area monitoring, changes controls, deviation, CAPA actions, ordering clean room material, support readiness before MFG activities, support proper room treatments after MFG activities, etc.
Maintain accurate disinfectant cycles overtime, as well as new technologies that the industry is adopting related to GMP spaces.
Maintain and control training status of the cleaning crew and the MFG team (as needed) for all the related SOPs.

Highly preferred skills and experience:
  • Associate’s degree in life science field or related area.
  • +3 (for lead)/ +1 (for technician) years of experience working with/in GMP areas for Biotech
  • Experience cleaning CGMP production suites and knowledge about disinfectant cycles and combinations
  • Technical writing skills and experience
  • Must have excellent organizational skills and be proficient in MS Office applications
Job Characteristics
  • Full time; mostly 8am-5pm Monday through Friday - however due to the nature of the manufacture schedule and cadence, this role will require the flexibility to work into evenings or on Saturday and Sunday (entire weekends), as needed due to production demands.
  • Reports to the Sr. Manager MFG
Physical requirements
  • This position requires the ability to frequently and regularly make efforts above the shoulders to mop ceilings.
  • This position requires the ability to frequently and repetitively move and/or pour 10 lbs (up to 40 lbs may occasionally be required)
EOE/DFW