We are seeking a Project Engineer to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland. The Project Engineer will be a member of the Engineering and Facilities Team (E&F) for the WRAIR PBF Building. E&F is responsible for oversight of the building and manufacturing infrastructure, environment, equipment, and utilities. This position will be responsible for executing the day-to-day operational activities required for th... more details
Project Engineer
Job LocationsUS-MD-Silver Spring
# of Openings
1
Category
WRAIR PBF
Type
Regular Full-Time
Min
USD $73,003.00/Yr.
Max
USD $106,000.00/Yr.
Overview
We are seeking a Project Engineerto support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland. The Project Engineer will be a member of the Engineering and Facilities Team (E&F) for the WRAIR PBF Building. E&F is responsible for oversight of the building and manufacturing infrastructure, environment, equipment, and utilities. This position will be responsible for executing the day-to-day operational activities required for that oversight. A candidate for this position will need to be a self-starter with strong communication skills and an ability to manage their own schedule, based on department and site goals and priorities.
PBF is a one-of-a-kind cGMP-compliant pharmaceutical manufacturing facility engaging in next-generation development for cutting-edge companies and government agencies. The professionals at PBF are engaging in trailblazing endeavors every day. Most exciting, the end products vary, so every year brings multiple opportunities for professional enrichment in original projects.
CAMRIS International, LLC, is a dynamic medical research and development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today’s most effective, evidence-based best practices. Our core practice areas include vaccine research, development, and production; microbiology and infectious disease research; biodefense; clinical research; global health security; and HIV/AIDS programs.
Our employees enjoy a diverse, collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.
Responsibilities
Plan, execute and document capital procurement initiatives in accordance with direction from Army and Civilian leadership.
Develop user requirement specification (URS) documents.
Verify equipment vendor compliance with stipulated design requirements, deliverables and factory acceptance testing (FAT) scope.
Support site acceptance testing (SAT), commissioning and validation efforts as required.
Oversee integration of equipment to facility systems and automation systems.
Manage subcontractors and vendors.
Coordinate with WRAIR Medical Maintenance to ensure timely repairs and maintenance of process and laboratory equipment.
Ensure that all facility systems are operating efficiently and effectively and documenting regular inspections of systems and equipment in the Facility.
Project manage various equipment and construction projects within the facility working with vendors, site engineers, facilities team members, and stakeholders monitoring status, coordinating project meetings, generating reports and ensuing engineering projects are delivered on time and within scope and budget.
Ensure that all site equipment is maintained and calibrated to manufacturer and regulatory requirements.
Coordinate with external maintenance teams and contractors for general and specialized repairs and maintenance.
Perform and support troubleshooting activities and process equipment configuration related to laboratory equipment and manufacturing.
Assist manufacturing and laboratory teams with setup, relocation, and removal of supporting equipment and systems.
Liaise with management on work order requests, system upgrades, and project-related activities, communicates facility constraints, and proposes/helps develop solutions.
Operate a Rockwell-based environmental & system monitoring (ESM) system.
Respond to urgent/emergency situations related to facility, utility, and equipment abnormal operation and failure.
Configure and respond to alarms generated by equipment and environmental monitoring systems.
Assist with and participate in training staff on equipment, systems, and utilities.
Escort external facilities maintenance teams and contractors within controlled areas of the facility for repairs and maintenance.
Perform other duties as assigned.
Qualifications
A bachelor's degree in engineering or engineering technology and 10 years of relevant experience or an equivalent combination of education and experience.
Strong communication skills to support coordination efforts between internal teams, contractors, facilities maintenance teams, etc.
A minimum of 5 years of experience working in a GMP facility.
Working knowledge of mechanical, electrical, and plumbing systems.
Working knowledge of common equipment found in a biotech production facility, including bioreactors, autoclaves, part washers, incubators, chromatography systems, filtration systems, etc., is preferred.
Proficient in general GMP documentation practices, processes, and procedures.
Ability to review, interpret, and document routine maintenance and calibration reports performed by third parties in the facility.
Effective at handling equipment failures and site emergencies, with a focus on personnel and product safety.
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.
Some positions or sites may require that the incumbent be fully vaccinated against COVID-19. Proof of vaccination may be required.
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.
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