Exton, PA (Research)
The ideal candidate will have manufacturing and facility/equipment 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
- Document all manufacturing and maintenance 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
- Document all cleaning activities and events in logbooks following SOP’s and documentation practices
- Maintain, store and monitor inventory of equipment
- Calibrate/Qualify equipment as needed to maintain cGMP compliance
- Assist with drafting SOPs, qualification protocols and other GMP documentation
- Perform assigned tasks per procedures compliant with cGMPs and participate in the clinical manufacturing of solid, semi-solid, and liquid formulations as needed
- Perform other related duties and responsibilities as assigned
- 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.