cGMP Facility Engineer

2 weeks ago

Frederick, United States Frederick National Laboratory for Cancer Research Full time

cGMP Facility Engineer

Job ID: req4076
Employee Type: exempt full-time
Division: Vaccine Clinical Materials Program
Facility: Frederick: G-WAY
Location: 7116 Geoffrey Way, Frederick, MD 21704 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 Vaccine Clinical Materials Program (VCMP), part of Leidos Biomedical Research at the Frederick National Lab, supports the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC). Its’ mission is to advance preclinical and clinical research, product development, and manufacture of novel clinical-stage vaccines and biologics to address current and/or emerging infectious diseases of global significance (e.g., HIV-AIDS, Influenza, Ebola, Malaria, Novel Coronavirus, Tuberculosis). The VCMP is responsible for the operation of a Frederick MD -based pilot plant facility and is actively engaged in cGMP manufacture, testing, release, and supply of Phase I /II clinical products for investigational use in the US and globally.

KEY ROLES/RESPONSIBILITIES

Provides technical support to field engineers, technicians, and product support personnel who are diagnosing, troubleshooting, repairing and debugging complex electro/mechanical equipment, computer systems, complex software, or networked and/or wireless systems. Responds to situations where first-line product support has failed to isolate or fix problems in malfunctioning equipment software. Reports design, reliability and maintenance problems or bugs to design engineering/software engineering. May be involved in customer installation and training. Provides support to customer/users where the product is highly technical or sophisticated in nature. Support the activities of the Facility Manager and maintenance staff in providing service to specialized systems. Independently review, evaluate and recommend approval plans and specifications pertaining to the installation, operation, maintenance, and alteration of buildings and large complex utility systems and equipment. Ensure compliance with sound engineering practices and established laws, codes, regulations, and standards and provide technical expertise to user personnel. Maintain facility drawings. Ensure ongoing operation and maintenance of process utility systems (e.g. clean steam, water for injection, glycol, RODI). Administer SAS and BAS systems including annual PMs. Conduct design review for facility upgrades/renovations. Provide review and oversight for new equipment installation. Coordinate/schedule annual facility shutdown activities. Assist with the execution of all tasks associated with the annual shutdown. Coordinate contract water treatment activities for boilers, chillers, heating hot water and chilled glycol systems. Monitor facility WFI usage and supply. Coordinate HEPA certifications with external contractor and VCMP validation. Author/write/lead FME-related change controls, SOPs, deviations and CAPAs as required. Ensure reliable operation of bio waste. Oversee system upgrades, as required. Ensure reliable operation of the electrical plant. Ensure reliable operation of the clean steam generators and loop. Ensure reliable operation of the chiller building and glycol loops.  Ensure reliable operation of the makeup air and air handling system. Respond to after-hours emergencies when needed to support critical Manufacturing production schedules

BASIC QUALIFICATIONS

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) or four (4) years relevant experience in engineering or pharmaceutical system design and installations in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency. In addition to the education requirement, a minimum of two (2) years related experience in engineering design and applications relating to utility equipment, process system design and modifications, new construction and renovations. Knowledge of the design and specifications for utility and equipment installation and modification, engineering theory techniques, and principles. Ability to perform onsite technical inspections of equipment and systems to ensure design and specification compliance. Ability to design and evaluate major complex specifications for mechanical, HVAC/R, electrical, or architectural systems. Assist other engineering personnel, as needed. This position is considered a safety-sensitive position and will be subject to random drug testing per the Leidos Biomedical Research Drug Free Workplace Program. Ability to obtain and maintain a security clearance.

PHYSICAL REQUIREMENTS

Physical requirements include the ability to maintain balance at all times, walk, kneel, hear (corrective appliance allowed), use of both hands, arms and legs, carry up to 50lb, lift >50lb, reach above shoulders, climb ladders, push/pull, repeated bending and stand for extended periods. Ability to obtain confined space certification Visual acuity to include depth perception, color distinction, and vision correctable to 20/40. Ability to wear Personal Protective Equipment (PPE) Ability to Enter a Laboratory or Encounter a Hazardous Area Ability to Kneel Ability to Operate and/or service equipment that contacts or transports compressed or liquid gas Pacemaker prohibited Repeated bending Exposure to temperatures below 32 degrees indoors for small amounts of time Exposure to temperatures above 90 degrees indoors for small amounts of time

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

Familiarity with scientific/lab equipment Familiarity with Computer Aided Design (CAD) Knowledge of MS Project for scheduling and task management Previous experience with cGMP biopharmaceutical process manufacturing procedures and equipment Previous experience with a Computerized Maintenance Management System (CMMS)

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.

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