Website Goodwin Biotechnology

Scope of Function: Under limited supervision, performs the cleaning of the GMP manufacturing cleanroom areas and a variety of preventative maintenance activities on storage equipment, GMP support utilities systems, and support facility areas. Candidate must be able to follow Standard Operating Procedures (SOP’s) and company policies.

Reports to: Facilities Director

 

Specific Duties:

  • Work with Facilitates GMP Cleaning Supervisor on the cleaning of all GMP manufacturing cleanrooms areas by using approved disinfectants and Standard Operating Procedures (SOP’s), and support basic janitorial responsibilities around the facility
  • Work with Facilities GMP Cleaning Supervisor to ensure one GMP/QC lab and two GLP/PD labs are cleaned and ready to support laboratories and process development operations
  • Work with Facilities GMP Cleaning Supervisor to ensure all Bio-hazard and Chemical waste material is collected and disposed based on EPA, Health Organization and OSHA regulations
  • Work with Facilities Director and Facilities Maintenance Supervisor on preventative maintenance for storage equipment, like freezers and refrigerators
  • Work with Facilities Director and Facilities Maintenance Supervisor on preventative maintenance activities for GMP utilities systems. These preventative maintenance activities include daily verifications of GMP utilities operational parameters, and this includes systems like a HPW System, Plant Steam Systems, Clean Steam Generator (CSG), Compressed Air Systems, Medical Grade Gases System, and Chilled Water System
  • Work with Facilities Director and Facilities Maintenance Supervisor on preventative maintenance activities for air handling systems. These activities include the monthly pre-filter verification, air handling belts and drainage of these systems
  • Work as a member of the emergency response team; this work function includes but it’s not limited to address emergency on equipment and systems due to malfunctions, and hurricane readiness activities
  • Candidate must be able to respond to emergency calls generated by the Environmental Monitoring Systems (EMS), and respond to emergencies in a proper manner
  • Responsible for following cGMP documentation practices and industry guidelines for manufacturing biologics. Candidate must be able to follow Standard Operating Procedures (SOPs)
  • Assist Facilities Department on the execution of engineering, renovation, and upgrades projects
  • Ability to lift up to 55Lbs

 

Education and Skills Required:

  • High School Diploma, Associate Degree in Engineering is preferred
  • A minimum of 3 years of experience in GMP Pharmaceutical/Biotech environment is preferred
  • Good mechanical, hands-on, and good documentation skills

Interactions:

  • Interact with all departments, and outside contractors.