Employment Opportunities » CQV / Quality Assurance Engineer
CQV / Quality Assurance Engineer
Job Type: Contract to Hire
Posted: October 1, 2019
Location: Greater Philadelphia Area
The Commissioning & Qualification Engineer will also provide support for our process design activities. This individual must be capable of working in an interdisciplinary environment as a contributing team member and independently on a wide variety of projects.
Our client is looking for someone with an overlap of experience between CQV, Quality assurance, and technical operations support. A team minded individual that can carry multiple different tasks and be part of cross-sectional teams to accomplish goals. They need individuals that have a technical background but are comfortable covering different types of tasks with a less defined role to help support the objectives of the team.
Typical Duties:
- Aseptic Process Simulation Guidelines and Study for the Drug Manufacturing Process
- Particle Study of the Drug Manufacturing Process
- Quality Issues / CAPAs
- Standard Operation Procedures for Operations, Quality Control, Final Drug Product and Sample Shipping, Facilities, and Maintenance
- Master Batch Records for CAR-T final drug product is a Plus
- Data Integrity Assessments for Computerized Instruments / Equipment
- Gowning Aids for clean room gowning
- Process/Facility and Process Flow Improvement suggestions
Additional Responsibilities:
- Interact with a variety of departments such as Validation, Engineering, Project Management and Quality Assurance, among others.
- Provide on-site startup, troubleshooting, and engineering services support to the client.
- Provide process and instrument and control design support.
Education/Experience:
- Engineering or science degree from ABET accredited university program.
- Minimum of five years related experience within a manufacturing environment.
- Experience with DCS, PLC, and other automation and control systems is a Plus
- Experience in a FDA regulated environment is a plus.
- Facilities Engineering support experience is a plus.
Skills and Special Requirements/Licensing:
- Excellent attitude, attention to detail and interpersonal relationship skills.
- Excellent documentation practices.
- Excellent organizational skills.
- Self-motivated and driven to succeed.
