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Validation Engineer I/II

Job ID: req1900
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.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

 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, software, and manufacturing processes used in the CGMP production of biopharmaceutical products
  • Generate, review, and process calibration records, engineering events (failures and change control), environmental and utility monitoring data & excursions, and similar engineering related data, SOPs, and records
  • Identify utility and equipment trends or problems and participate in the diagnosis and implementation of appropriate solutions

 BASIC QUALIFICATIONS

This position may be filled with a Validation Engineer I/II commensurate with the selected candidates experience. 

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

  • Possession of Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a science, technical, or engineering discipline or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
    • Validation Engineer I - No work experience required with a Bachelor's degree
    • Validation Engineer II- 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
  • Well organized, with the ability to work both independently and as part of a group
  • 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 drafting, executing, data analysis, or reviewing of validation protocols
  • Experience writing or revising SOPs and technical reports
  • Experience with use of validation tools and equipment such as temperature mapping devices i.e. Kaye or Ellab, multi-meters, temperature standards, temperature baths/heat blocks, and biological indicators.
  • Experience with operation, maintenance, and troubleshooting of equipment, software, and utilities to support biopharmaceutical operations including fermentors, bioreactors, autoclaves, ovens, washers, chromatography skids, HVAC, WFI, and clean/pure steam.
  • Knowledge of aseptic operations, aseptic filling, or airflow visualization principles
  • Ability to read and understand engineering P&ID and layout drawings
    Proficiency with basic hand tools and a foundational knowledge of mechanical principles
  • 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
  • Proficiency with software application including Microsoft Office, Microsoft Project, Blue Mountain Regulatory Assets Manager (BMRAM), Kaye Validator, Master Control, and Microsoft Access

EXPECTED COMPETENCIES

  • Strong written and verbal communication

JOB HAZARDS

  • This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations
  • 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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