4G Careers

Validation Engineer

Wellesley, MA
Nottingham, UK
Basel, Switzerland
Amsterdam, Netherlands

Validation Engineer


Recognized as one of Fortune's 2018 Best Workplaces in Bio/Pharma, 4G Clinical has an opening for a full-time Validation Engineer in our Wellesley, Nottingham and Basel offices.

Responsibilities
:

The Validation Specialist will work with the Delivery team and Software Testing Analysts (STA) to coordinate and monitor validation activities and deliverables for study related projects, and ensure that validation remains intact throughout a study’s lifecycle according to 4G Clinical procedures.

Key Accountabilities of the Validation Specialist include the following:

  • Ensure artifacts and deliverables for client projects are delivered and approved in timely fashion
  • Approve progress of studies through each phase of the study lifecycle
  • Develop Validation Plans and Reports
  • Ensure validation state of studies is maintained with an emphasis in quality
  • Work with STAs to ensure quality in Internal Testing
  • Assists in investigations and resolutions for study related deviations and CAPAs
  • Assist in day to day scheduling of validation deliverables where required
  • Assist other departments with tasks as appropriate

Required Experience:


  • The position requires a minimum of 3 years’ experience in the clinical research field, particularly RTSM/IRT services delivery and/or Quality Assurance.
  • Knowledge of US FDA Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) GCP regulations, Electronic Records; Electronic Signatures regulation (21 CFR Part 11) and EU Annex 11, and associated regulatory guidance documents.
 

Education and/or Certification Requirements:

  • The candidate must possess a bachelor’s degree in a life sciences or equivalent experience

Other Skills/Requirements:

  • Strong technical writing skills
  • Motivated to work in a fast paced constantly changing environment
  • Strong organization, multi-tasking and prioritization skills
  • The ability to escalate in a professional manner
  • Demonstrable resilience in prioritizing quality against aggressive time constraints
  • Experience with IRT/RTSM and quality system tools is a plus

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