• Hot Job
  • Product Management
  • Quality Engineering
  • Telecommute
  • Full Time
  • USA, Nationwide
  • $85,000 - $110,000 USD / YEAR
  • Salary: $85,000 - $110,000

Company

We are a rapidly growing company supporting global clinical trials. We are building the future of healthcare, where many more life-changing therapies can reach those who need it most.

Together with the top pharmaceutical and biotech partners, we’re scaling a new model for the clinical trial site, where more physicians and their patients engage in cutting-edge research to develop and approve new therapies faster.

Through innovation and a unique technology-enabled service model, our team of expert scientists, engineers, entrepreneurs, physicians, nurses, and patient volunteers are paving the way towards this more caring and creative world.

We offer:

  • Interesting work and many opportunities for professional growth
  • Competitive salary, benefits,  and other incentives

Job Description

We are looking for an Computer System Validation (CSV) Engineer to drive GxP validation lifecycle management activities for computerized systems and equipment, ensuring that all activities are completed and documented in accordance with cGCP’s that fulfill relevant federal regulations and standards.

The ideal candidate will be experienced in creating and implementing validation plans, working closely with key stakeholders to develop validation deliverables, ensuring fit for purpose and testing requirements are defined, and in compliance with the Master Validation Plan and applicable cGCP regulations. Our goal is to ensure systems and people are effective and function within the limits of budget, time and specifications of the company while complying to regulatory requirements and industry best practices.

Main Responsibilities

  • Prepare validation deliverables for computerized systems, including Validation Plans, Requirements Specifications, Configuration Specifications, Risk Assessments, Test Scripts, Traceability Matrices, and Validation Summary Reports.
  • Coordinate and schedule system vendors with respect to the execution of Installation, Operation, and Performance Qualification (IQ/OQ/PQ) protocols, and subsequent Re-Qualification (RQ) protocols if applicable for new and in-use equipment to ensure compliance with site procedures, Master Validation Plan (MVP), and regulatory requirements.
  • Assist system SMEs in the preparation of test scripts comprising formal testing of functional, system, and regulatory requirements in conjunction with computerized system validation. Oversee test script execution.
  • Work with Operations and Quality to assess risk and impact with respect to proposed changes within the facilities and validated processes.
  • Provide ongoing Qualification/Validation and other appropriate System Lifecycle training/education of staff.
  • Provide ongoing support for Data Integrity projects to identify and ensure the safeguarding of data in compliance with procedures, regulatory requirements, and corporate policies.
  • Organize an efficient method to ensure all requirements of assigned validation deliverables are completed and that validation efforts are executed in a timely manner.
  • Participate in the development of corrective actions as needed for deficiencies that may be uncovered/observed during validation efforts in regard to processes, test methods, facilities, computer software/systems, SOPs, and other related issues in order to assure compliance with applicable regulatory requirements/guidelines, procedures, and policies.
  • Participate in the development of CAPAs and assess the effectiveness of the corrective action.
  • Assist during client and regulatory audits

Qualifications

Must-haves

  • BS in  a Scientific, Engineering, IT discipline, or a related field.
  • 5+ years’ experience of computerized system validation experience in a pharmaceutical, clinical, biotechnology, and/or the biomedical industry.
  • Strong documentation development and technical writing skills
  • In-depth knowledge of accepted industry practices and the regulatory requirements that govern Computer System Validation in the pharmaceutical industry.21 CFR Part 11 and applicable ICH, IRB, and FDA guidances.
  • Proven track record in project management and can manage multiple projects
  • Excellent organizational, communication, and time management skills
  • Ability to thrive in a fast-paced startup environment

Pluses

  • Working knowledge of lab equipment/instrumentation, test method, process, and facility validation in a regulated environment is preferable.
  • Relevant industry certifications (CPVP, GMPCP, CMDCP)

Additional Information

Location:  Anywhere in the USA. This is a remote position. Our headquarters are in Boston, MA.
All candidates must be US Citizens or Green Card holders.

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