Change Control Engineer

  • Company:
    PSC Biotech
  • Location:
  • Salary:
    negotiable / month
  • Job type:
  • Posted:
    6 hours ago
  • Category:

Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies with services designed to help achieve regulatory compliance requirements. PSC Biotech Corporation serves over 350 clients in more than 23 countries through professional services consulting, cloud-based software solutions, and pharmaceuticals contract manufacturing. PSC Biotech Corporation has three unique active divisions within the parent company, each representing one of our areas of expertise: PSC Biotech, PSC Software, and BioTechnique. Together, these divisions enable us to meet the ever-changing needs of our clients with a commitment to excellence and superior quality. Our PMO department is looking for a highly experienced change control engineer at one our clients location, Details are as follows: Responsibilities: Must be mid-senior level (at least 8 years) Must be well versed in writing, executing, and coordinating Change Controls, especially in packaging/process equipment and clean room/classified area modifications Familiarity with generating Change Controls through Trackwise is a plus Will need to be able to manage various facilities, packaging and process equipment, and aseptic operation projects Projects may include clean room/classified area modifications, equipment upgrades/modifications, equipment installation, etc. Equipment include Vial Packaging Lines, Solid Dose Lines, Aseptic Fill Lines, Lyos (freeze dryers), parts washers, autoclaves, vial washers, etc. Processes include Aseptic operations, ISO 8 operations, hydration, filling, component preparation Must be a great communicator to be able to represent PMO in change controls Have an understanding of ISO 8/ISO 5 requirements for equipment/facilities Requirements Bachelors degree. Excellent math and analytical ability Excellent English, both written and spoken Strong organizational and problem-solving skills #PSC