Validation Engineer I
Cranbury, NJ /
Manufacturing – Validation /
Work at ROCKET PHARMA and help cure rare diseases!
Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for hands-on team players who enjoy collaborating with colleagues. We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator. In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.
We are seeking a Validation Engineer I responsible for ensuring the fitness-for-use of Rocket’s GxP systems. The incumbent will be responsible for working with functions throughout the organization to successfully carry out Rocket’s Facility, Utilities, Process and Analytical Equipment and computerized system qualification strategy through a risk-based approach.
- Assists with developing qualification protocols, and associated reports while adhering to a change management process.
- Supports the execution of equipment/systems qualifications and validation protocols.
- Supports vendors qualification functions.
- Assists with developing written procedures for operation and preventive maintenance of equipment and systems.
- Assists with developing validation/qualification deliverables such as Requirements Specifications, Risk Assessments, Traceability Matrices, and Summary Reports.
- Supports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment/systems to meet business needs in accordance with required schedules or dates.
- Completes all calibration, qualification and validation documentation with accuracy, completeness, and compliance to Rocket standards.
- Regularly reviews, prioritizes, and promptly responds to customer equipment qualification/system validation and support requests.
- Interfaces with customers to ensure all expectations are being met.
- Maintains a positive relationship with all team members and site customers while promoting a positive team environment.
- BS degree (minimum) in engineering or biological sciences.
- 3+ years of experience in validation, and quality assurance, quality control, biomanufacturing, clinical and/or regulatory operations
- 1+ years of direct experience in the Equipment validation/qualification, utility and facility qualifications
- Hands on experience working with GAMP 5 systems and 21 CFR Part 11 compliance.
- Demonstrated ability to interpret and apply pharmaceutical industry regulatory compliance requirements with an emphasis on US and EU/MHRA data integrity guidance.
- Ability to work as part of a cross-functional team in a dynamic, fast-paced environment.
- Ability to effectively communicate with team members, contractors and vendors.
A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.
Full COVID-19 vaccination is required for employment at Rocket Pharmaceuticals.