Biopharmaceutical Validation Engineer I / II
Job ID: req3934
Employee Type: exempt full-time
Division: Clinical Research Program
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.
PROGRAM DESCRIPTION
The Biopharmaceutical Development Program (BDP) of Leidos Biomedical Research, Inc. supports the Frederick National Laboratory Cancer Research (FNLCR) 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
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
- Possession of Bachelor's degree in a science, technical, or engineering discipline from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) 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 Bachelors degree
- Validation Engineer II: In addition to the education requirement, a minimum of two (2) years' related experience in the pharmaceutical, biopharmaceutical, &/or biologic industries
- Ability to obtain and maintain a security clearance
PREFERRED QUALIFICATIONS
Candidates with these desired skills will be given preferential consideration:
- Two (2) years of job related experience in a GMP or related position in the pharmaceutical, biopharmaceutical, &/or biologic industries
- 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
- Strong written and verbal communication
- Well organized, with the ability to work both independently and as part of a group
JOB HAZARDS
- This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations
Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.