Quality Engineer II

Location
Frederick, MD, USA
Posted
Oct 24, 2018
Ref
JR82-70074
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
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

THIS POSITION IS CONTINGENT ON FUNDING APPROVAL
  • 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, 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

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


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