Career Opportunity: Step into the Role of Equipment Validation Engineer!
Are you passionate about ensuring the quality and compliance of pharmaceutical equipment in the dynamic field of cell therapy? Do you thrive in a collaborative environment where your expertise is valued, and your contributions make a difference? If so, we have an exciting opportunity for you!
Position: Equipment Validation Engineer
Location: Onsite (100%), Summit, NJ
Duration: 6 months (High Possibility of Extension)
Role Overview:
- As an Equipment Validation Engineer, you will play a crucial role in implementing and maintaining process/lab equipment critical to our cell therapy operations. You will commission and qualify new equipment facilities and utilities, ensuring they meet the highest standards of compliance and validation. With your expertise, you will support internal customers, collaborate with external service providers, and participate in projects that drive our continued success.
Key Responsibilities:
- Develop qualification protocols and associated reports, adhering to change management processes.
- Supervise vendors for qualification functions and manage projects within your functional area.
- Provide technical support and guidance on equipment qualification issues to internal customers.
- Maintain qualified equipment systems in compliance with policies, guidelines, and procedures.
- Ensure completion of all qualification and validation documentation with accuracy and compliance to standards.
- Support equipment implementation projects, including scheduling, procurement, installation, and qualification.
- Regularly review, prioritize, and promptly respond to customer equipment qualification and support requests.
Required Skills and Qualifications:
- Bachelor’s degree in Engineering or Science-related discipline.
- Minimum of 5 years’ experience in a GMP environment, with at least 3 years in equipment qualification.
- Knowledge of regulatory requirements such as cGMP, GXP, GAMP, and SDLC.
- Strong written and verbal communication skills.
- Advanced knowledge of pharmaceutical, manufacturing, and laboratory systems.
- Proficiency in Microsoft Office Suite and database systems.
- Strong multi-tasking ability and proven organizational skills.
Join Us: If you are ready to take on this exciting challenge and contribute to cutting-edge advancements in cell therapy, we want to hear from you! Apply now and become part of our dedicated team shaping the future of healthcare.
About SSi People:
With over 25 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.