Exton, PA (Research)
EXTON- CMC / R&D Facility
The ideal candidate will have manufacturing and equipment qualification/cleaning experience in a regulated pharma or biotech environment (GMP, SOPs, etc.).
• Assist in the equipment and GMP facility set up, operation, and maintenance as required
• Perform assigned tasks per procedures compliant with cGMPs and participate in the clinical manufacturing of solid, semi-solid, and liquid formulations as needed
• Document all manufacturing, maintenance and qualification activities and events in logbooks following SOP’s and documentation practices
• Clean GMP and R&D equipment as needed to the standards necessary to meet cleaning validation requirements
• Maintain, store and monitor inventory of equipment
• Assist with drafting SOPs, qualification protocols and other GMP documentation
• Occasionally, perform other related duties and responsibilities as assigned, including raw material and finished product receiving, logging, staging, shipping, etc.
• High School Diploma/GED. Bachelors Degree in scientific discipline preferred
• Must be able to read, understand, and follow SOP’s
• Strong oral communication and interpersonal skills
• Ability to perform physical duties including:
Lifting and carrying up to 50 lbs. / Walking, standing, bending, stooping
• Potential exposure to particulates, vapors or noisy environment. Must be able to wear Respirator or Dust Mask.
Experience with cGMP guidelines and regulations is a plus