Immediate Need: CQV Engineer
Location: Swiftwater, PA
Start Date: January 13th, 2025
Duration: >3 years (seeking full time employment with salary and benefits)
We are urgently seeking a skilled CQV (Commissioning, Qualification, and Validation) Engineer to join a critical technology transfer project in Swiftwater, PA. This role is ideal for someone with expertise in pharmaceutical manufacturing and a passion for navigating complex challenges in a fast-paced environment.
About the Project:
This project involves transferring a vaccine process to an existing manufacturing and laboratory facility, accommodating both small- and large-scale production. While the project includes some retrofit aspects, it’s focused on integrating new product operations within an existing infrastructure.
Phases: Combined feasibility and conceptual phases currently underway, with the design phase slated for early next year.
Challenges: Extreme scheduling pressures and tight deadlines require a dynamic problem-solver who thrives under pressure.
Key Responsibilities:
- Execute CQV activities for equipment and processes, ensuring adherence to regulatory standards and project timelines.
- Support the technology transfer of vaccine processes into an existing facility.
- Develop and execute IQ, OQ, and PQ protocols for small- and large-scale manufacturing and lab operations.
- Collaborate with cross-functional teams to address technical challenges and scheduling constraints.
- Provide detailed documentation and reporting to support regulatory compliance.
Qualifications:
- Bachelor’s degree in engineering, Life Sciences, or a related field.
- Strong experience in CQV, particularly in technology transfer projects within the pharmaceutical or biotech industries.
- Familiarity with retrofitting existing facilities and integrating new product operations.
- Proven ability to manage scheduling pressures and tight deadlines in a high-stakes environment.
- Solid understanding of GMP, FDA regulations, and vaccine manufacturing processes.
What We Offer:
- The opportunity to contribute to a high-impact vaccine technology transfer project.
- A fast-paced, collaborative environment where innovation and problem-solving are key.
- Competitive compensation and a chance to work on the cutting edge of pharmaceutical engineering.
Apply Now! This is an urgent hire for an immediate start. If you’re up for the challenge, send me a message for more details!
