Validation Engineer I

Highly Competitive
  1. Permanent
  2. Validation
  3. United States
Gaithersburg, Maryland
Posting date: 05 Apr 2019

ProClinical is currently recruiting for a Validation Engineer position on behalf of a top 10 global pharmaceutical company located in Maryland. This vacancy is an exciting opportunity to work at a top 10 global pharmaceutical company that employs approximately 100,000 people worldwide.

The Validation Engineer will support support Data Integrity (DI) activities associated with computerized laboratory instruments. These include data integrity assessments, identification of corrective actions and remediation of gaps for analytical instruments across manufacturing and laboratory areas.

Job Responsibilities:

  • Supporting the completion of standardized system assessment tool with key stakeholders for all analytical instruments.
  • Developing CAPA plan and perform, as directed, corrective actions to address DI findings.
  • Authoring and/or revising analytical instrument User Requirements Specifications to align with DI and standards.
  • Authoring final reports summarizing execution of analytical instrument qualification protocols.
  • Authoring support documents (amendments, repeat test forms, addenda and deviations) in support of analytical instrument qualifications.
  • Ensuring compliance with and completion of deliverables as specified within the Data Integrity Plan.
  • Ensuring analytical instruments are maintained in a qualified state.
  • Supporting the analytical instrument validation program to assure compliance with GQMS and AEQMS. times.
  • Supporting the implementation and mitigation of gaps associated with the Data Integrity Plan.
  • Working closely with System Owner, Manufacturing, QA, QC, IT and Validation groups.
  • Familiarity with laboratory environments, analytical instruments and computerized systems.

Skills and Requirements:

  • A degree in an appropriate science (chemistry, biology, biochemistry, etc.) based discipline.
  • Demonstrable competence through significant experience in their degreed discipline.
  • Familiarity with the operation of analytical instruments and their operating systems.
  • Familiarity with computerized system validation and data integrity.
  • Knowledge of cGMPs.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Sarah Beshara at + 267-477-3355 or upload your CV on our website -

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.