Goodwin Biotechnology

Scope of Function: Responsible for directing a professional team of individuals in all routine maintenance activities on GMP support equipment and systems. This candidate should be able to develop, revise, and direct preventative maintenance Standard Operating Procedures (SOP), and company policies to ensure prompt completion of important tasks to support company goals and
clients’ projects.

Reports to:  Associate Vice President Technical Operations

 

Specific Duties: 

  • Collaborates with cross-functional teams and systems
  • Supports and writes investigations and assists in development and implementation of CAPAs
  • Assists in the execution of the scheduled preventative maintenance and documentation of Work Orders
  • Oversees and directs maintenance personnel with repairs
  • Hold direct report team accountable for performance
  • Conduct annual performance review of direct reports
  • Support and develops responses for internal and external audits
  • Develop Standard Operating Procedures (SOPs) and Change Controls pertaining to setup, maintenance, and operation of equipment, facility, and utilities
  • Support the purchase and implementation of new equipment and spare parts
  • Identify the equipment, systems and processes that do not operate efficiently. Develop and implement corrective actions to improve efficiency
  • Ensure that required parts are available for the projects, preventative maintenance and repairs
  • Coordinates activities of outside contractors to ensure projects, maintenance and PM(s) are completed on time and correctly
  • Support validation of the equipment and systems
  • Maintains 100% on-time completion of PMs and certifications.
  • Plan and schedule the Boiler, Fire Extinguishers and Waste Management Annual PM and inspections
  • Responsible for equipment upgrades and completing necessary equipment change control documentation
  • Responsible for daily data logging/reviewing of the Environmental Monitoring System for Temperature and RH conditions
  • Other duties as assigned

 

Education and Experience Required:

Must have demonstrated knowledge of electrical and mechanical systems in a regulated environment.

  • Bachelor’s degree in Engineering, Mechanical, Industrial, Electrical
  • 3 years related pharmaceutical, biotech or medical devices
  • Facility /Industrial maintenance experience
  • Strong Technical Writing skills
  • Ability to manage multiple priorities and advance several tasks in parallel
  • Experience supervising, leading and mentoring technicians 

Interacts with: 

  • All Departments

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.