Manufacturing / Validation Specialist


Responsible for completing manufacturing related activities, objectives and projects during the process of manufacturing clinical supplies, performing scale-up and validation activities and preparing for commercial launch of Summit nasal spray products. Performs validation activities, including writing protocols and reports and compiling data and attachments into comprehensive validation packages. Also responsible for assisting with the development of procedures, specifications, validation protocols and other validation and engineering related documentation. May also perform routine preventive maintenance activities and manage projects.

Essential Duties:  

  • Operate, monitor, calibrate and maintain equipment and systems used to support manufacturing and laboratory operations.
  • Maintain an adequate inventory of spare parts for all plant and manufacturing equipment.
  • Write and revise SOPs, PM cards and Forms to maintain up to date and accurately reflect the current procedures.
  • Keep all plant systems and manufacturing equipment operating efficiently and well maintained.
  • Maintain assigned areas neat and orderly and in compliance with SOPs and cGMPs.
  • Work on multiple validation projects simultaneously and coordinate test work with various other departments.
  • Write protocols for manufacturing, utility and lab equipment and processes.
  • Execute validation work according to protocol instructions and procedures.
  • Plan, coordinate and track the progress of validation projects.
  • Compile validation packages and assure all required documentation is complete.
  • Champion process improvement projects and ensures equipment and systems remain in a state of control.
  • Assist with the implementation of a validation training program and the training of new personnel and contractors.
  • Other duties as assigned. 

Qualifications:

  • BS in Biology, Chemistry, Engineering or related science or equivalent experience
  • Excellent technical writing and organizational skills
  • Self-starting and multitasking
  • Extremely detail oriented
  • 3-7 years of experience in a cGMP manufacturing environment including hands-on validation experience
  • Ability to work with cross functional teams and meet performance deliverables
  • Good interpersonal skills and the ability to work well in a team environment