Foundedin 1996, PSC Biotech Corporation was created with the vision of providing lifescience companies with services designed to help achieve regulatory compliancerequirements. PSC Biotech Corporation serves over 350 clients in more than 23 countriesthrough professional services consulting, cloud-based software solutions, andpharmaceuticals contract manufacturing. PSC Biotech Corporation has threeunique active divisions within the parent company, each representing one of ourareas of expertise: PSC Biotech™, PSC Software™, and BioTechnique™. Together,these divisions enable us to meet the ever-changing needs of our clients with acommitment to excellence and superior quality.
OurPMO department is looking for a highly experienced change control engineer atone our client’s location, Details are as follows:
- Mustbe mid-senior level (at least 8 years)
- Mustbe well versed in writing, executing, and coordinating Change Controls,especially in packaging/process equipment and clean room/classified areamodifications
- Familiaritywith generating Change Controls through Trackwise is a plus
- Willneed to be able to manage various facilities, packaging and process equipment,and aseptic operation projects
- Projectsmay include clean room/classified area modifications, equipmentupgrades/modifications, equipment installation, etc.
- Equipmentinclude Vial Packaging Lines, Solid Dose Lines, Aseptic Fill Lines, Lyos(freeze dryers), parts washers, autoclaves, vial washers, etc.
- Processesinclude Aseptic operations, ISO 8 operations, hydration, filling, componentpreparation
- Mustbe a great communicator to be able to represent PMO in change controls
- Have an understandingof ISO 8/ISO 5 requirements for equipment/facilities
- Excellentmath and analytical ability
- ExcellentEnglish, both written and spoken
- Strongorganizational and problem-solving skills.
Bachelor’s degree. Excellent math and analytical ability Excellent English, both written and spoken Strong organizational and problem-solving skills