Senior Process Associate

2 days ago


Exton, Pennsylvania, United States PSG Global Solutions Careers Full time
Job Title: Sr. Principal Process Associate

We are seeking a highly skilled and experienced Sr. Principal Process Associate to join our team in the Pharmaceuticals and Medical Products industry. As a key member of our operations team, you will be responsible for providing hands-on support and leadership in the operation of equipment to support preclinical, phase I and phase II clinical trials.

Key Responsibilities:
  • Coordinate equipment maintenance, calibration, and validation with internal departments.
  • Support the transfer of new processes and technologies for media, buffer, and excipient preparation working with R&D and technology transfer laboratory personnel.
  • Monitor process performance, operational excellence activities, and process improvement strategies.
  • Lead the qualification/validation program for Pilot Plant equipment/systems by supporting commissioning, initial testing, requalification, and validation maintenance activities.
Requirements:
  • Minimum of 7-10 years progressive experience in a multi-discipline cGMP manufacturing environment.
  • Proficient in weigh, dispense, and sampling procedures for controlled raw materials.
  • Knowledgeable in technology transfer, equipment validation, and facility startup.
  • Ability to identify, investigate, and resolve basic process and equipment problems.
  • Strong working knowledge of international cGMP regulations.
About Our Client:

Our client is an award-winning clinical development company with 20+ years of experience in clinical research and strategic resourcing. We are committed to improving lives globally through comprehensive solutions and customized delivery models.



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