Facilities Engineer
Camris International

Overview

CAMRIS International, LLC is a medical research and development firm that realizes innovative solutions to health and development challenges through high-quality, cost-effective program and research management services. We combine our proven systems with today's most effective, evidence-based best practices to improve the lives of people around the world. Our core practice areas include HIV/AIDS, microbiology and infectious disease research, vaccine research, development and production, global health security, biodefense, and clinical research.

We are seeking a Facilities Engineer to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland.

Responsibilities

• Interacts with a team of technicians, QA personnel, QC personnel, equipment vendors, service providers, and government management and departments to ensure proper cGMP operation of the Pilot Bioproduction Facility (PBF) for the purpose of successfully producing vaccines and other biological materials.
• Understands, maintains knowledge of, and takes action as needed on all manner of system and equipment issues that occur at the PBF. Becomes familiar with systems and equipment being installed as part of building construction being conducted by WRAIR. Uses this knowledge to facilitate actions necessary to keep them in good operational order and to assist the QA Manager in evaluating the impact of non-routine activities to the validation status of the system/equipment and to the safety and quality of manufactured products.
• Assures that information relating to equipment activities is properly documented and approved.
• Follows current Good Manufacturing Procedures (cGMP) guidelines and FDA regulations as they apply to all levels of work.
• Oversees the following functions that are within the scope of this position: coordination, tracking, execution and review of preventive, routine, and emergency maintenance, new equipment acquisition and upgrades, old equipment disposal (per Army procedures), and other facility/system/equipment related activities as they are required by the Army.
• Assists QA in executing and maintaining calibration and validation processes.
• Acts as liaison for the PBF with government, contractor personnel, and equipment and equipment service providers and keeps the PBF staff informed of progress. Provide progress reports as needed.
• Coordinates facility system needs as per cGMP requirements to ensure compliance.
• Schedules bioprocessing systems repair and maintenance activities with Army personnel or outside contractors as needed. Interface with manufacturing personnel to coordinate validation, repair, calibration and preventive maintenance (PM) activities to maintain the production schedule. Coordinates outside technicians who are scheduled to repair/maintain equipment and systems within the PBF. Directs them to the appropriate sites in the building and/or equipment as appropriate. Observes and monitors workers while on site in order to prevent unauthorized changes to equipment facilities and utilities and reviews documentation of activities (including logbooks) for completeness and accuracy. Tracks PM and calibration activities and communicate progress to all laboratory and Quality Assurance (QA) personnel within the PBF.
• Assists in evaluating and recommending outside contracting services and additional equipment as needs arise.
• Completes internal documentation to record the activities for cGMP purposes/equipment files. Review documentation to detect system/equipment changes. As needed, assists PBF Management in assessing the impact of changes. Assists QA management in maintaining files containing documentation of equipment and systems activities per cGMP requirements. Has review and signature authority for maintenance documentation. Provides information regarding these activities to other government personnel as needed.
• Participates in the development and review process for validation activities for facility systems.
• Provides assistance with review and resolution of deviations, failure investigations, and critical changes that impact validation documents.
• Tracks schedule and completion of repairs, PM, and other actions that are ongoing by the Army facility personnel and contractors to effect timely progress in compliance with cGMP regulations.
• Periodically reviews ongoing monitoring data (refrigerator/freezer performance, delta pressures, temperatures, etc.) to detect signs of impending equipment/system failure. Responds to system alarms in order to prevent or minimize losses to cGMP systems and materials.
• Must have familiarity with various types of office software: Outlook, Word, Excel, MS Project or LIMS experience a plus.
• Maintains a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer.
• Performs light duties and other related duties as required and assigned.

Qualifications

• A BS/BA degree in biology or related field or in engineering and equivalent work experience.
• At least 5 years of employment at a cGMP biotechnology, pharmaceutical, or related facility.
• At least 4 years of experience in facility engineering in the areas of facility systems/controls, validation, maintenance, and/or repair. Equipment troubleshooting capabilities are essential.
• Must have an understanding of cGMP requirements as they relate to environments and equipment for the production of drug products.
• Must be proficient in the general use of various types of office software: Outlook, Word, Excel, MS Project or LIMS experience a plus.
• Must have familiarity/knowledge of building/equipment monitoring systems.
• Must have familiarity/knowledge of cleanrooms and cleanroom requirements. Work may involve the need for aseptic gowning.
• Must have ability to follow directions, written policies and procedures for work responsibilities.
• Ability to establish and maintain effective working relationships with coworkers, managers and customers.
• Must be able to work independently following a brief period of specific technical training.

CAMRIS International LLC offers competitive salaries and comprehensive benefits. Please submit your resume online at www.CAMRIS.com . CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.

Full vaccination against COVID-19, defined as two doses of Moderna, two doses of Pfizer, or one dose of Johnson & Johnson's Janssen, is required for this position.

Employment is contingent upon successful completion of a background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment, education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding.

This job has expired.