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Computer System Validation Engineer

Location
Cranbury, New Jersey
Job Type
Permanent
Posted
1 Aug 2022
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 Computer System Validation Engineer responsible for ensuring the fitness-for-use of Rocket s GxP computer systems. The incumbent will be responsible for working with functions throughout the organization to successfully carry out Rocket s computer system validation strategy through a risk-based approach that ensures the quality and integrity data over the entire system lifecycle.
Responsibilities
Apply Rocket Quality Standards and cGMP requirements to the validation of computer systems, inclusive of hardware, software, procedures, and training required to demonstrate fitness-for-use of the system.
Understand and apply Data Integrity principles (ALCOA+) to ensure system validation requirements include appropriate testing strategies
Facilitate the Computer System Validation risk assessment to identify validation deliverables and requirements during the development of the project
Collaborate with Quality Assurance and cross functional teams to ensure that operational processes such as change management, backup policy, configuration management and periodic reviews are efficient and effective.
Develop and execute validation deliverables to support project activities including requirements development, user acceptance testing, documentation (SOPs, validation, configuration specifications, traceability matrices, protocols, reports, etc.) and training.
Compile and analyze validation data and work with technical teams to perform trouble-shooting activities during the validation process.
Maintain a complete and accurate computerized systems list that may be used to prioritize periodic risk reviews and other improvement initiatives.
Participate in internal and external audits/ inspections as a subject matter expert with up-to-date knowledge of evolving regulatory and technical requirements and expectations.
Maintain close communication with stakeholders to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues.
Create and maintain documentation templates to speed the documentation process.
Support ongoing equipment qualification and automation activities.
Requirements:
BS degree preferably in Computer Science, Engineering or Biological Sciences.
5+ years of experience in validation, IT, quality assurance, quality control, biomanufacturing, clinical and/or regulatory operations
3+ years of direct experience in the validation of computerized systems
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
Proven success in the application of data governance measures.
Ability to communicate clearly and persuasively through data and data visualizations.
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.
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Details

  • Job Reference: 673964483-2
  • Date Posted: 1 August 2022
  • Recruiter: Rocket Pharmaceuticals
  • Location: Cranbury, New Jersey
  • Salary: On Application
  • Sector: Engineering
  • Job Type: Permanent