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Validation Eng II

Job ID: req1476
Employee Type: exempt full-time
Facility: ATRF: Other
Location: 8560 Progress Drive, Frederick, MD 21701 USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc.  The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public’s interest.  

 Position Overview:

PROGRAM DESCRIPTION         

The Biopharmaceutical Development Program (BDP) of Leidos Biomedical Research, Inc. supports the National Cancer Institute (NCI) and other government agencies through the development of novel agents for first-in-man clinical studies.

KEY ROLES/RESPONSIBILITIES

  • Responsible for the setup, operation, and maintenance of equipment and instrumentation used in the validation and quality oversight of facilities, utility systems, process equipment , and manufacturing processes used in the cGMP production of biopharmaceutical products
  • Generate, review, and process calibration records, engineering events (failures and change control), environmental monitoring data & excursions, and similar engineering related data, SOPs, and records
  • Identify utility and equipment problems and participate in the diagnosis and implementation of appropriate solutions

 BASIC QUALIFICATIONS

  • Possession of a Bachelor’s degree from an accredited college or university, according to the Council for Higher Education Accreditation, in a science, technical, or engineering discipline. (Additional qualifying experience may be substituted for the required education)
  • In addition to educational requirements, a minimum of two (2) years of job related experience in a GMP or related position in the pharmaceutical, biopharmaceutical, &/or biologic industries
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • GMP calibration, validation, environmental & utility monitoring, and related experience
  • Experience with GMP process, equipment, and/or systems calibration & validation, document preparation, and analysis
  • Familiar with the calibration, validation, use, and maintenance of biopharmaceutical GMP equipment, utilities, and facilities
  • Knowledge of biopharmaceutical facility, utility, and equipment requirements, use, and maintenance
  • Knowledgeable and skilled at compliance, training, auditing, and investigation of non-conformances
  • QA compliance experience including GMP documentation, change control, non-conformance investigation, and corrective and preventative action administration

EXPECTED COMPETENCIES

  • Strong written and verbal communication
  • Ability to work independently or as a part of a team; including with management, project scientists, engineers, and operators/technicians

JOB HAZARDS

  • This position is subject to the environmental conditions such as working outdoors, high humidity areas indoors, dampness and chilling, dry atmospheric conditions, etc. as part of the job

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

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