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Company

Original Job Post

CAMRIS · 2 days ago

Facilities Engineer

Silver Spring, MD

Full-time

Onsite

Senior Level

5+ years exp

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BiotechnologyInformation Technology

Comp. & Benefits

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Responsibilities

Ensure business continuity through effective strategic and tactical planning of equipment selection, commissioning, training, and use.

Develop and maintain the Disaster Recovery Plan for the PBF site.

Coordinate and build relationships with WRAIR facilities and Safety teams and associated contracted support to ensure that all facility systems are operating efficiently and effectively and documenting regular inspections of systems and equipment in the Facility.

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.

Ensure that all facility systems operate efficiently and effectively and document regular inspections of systems and equipment in the Facility.

Support SAT, FAT, and Validation efforts as required.

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 ensuring engineering projects are delivered on time and within scope and budget.

Ensure all site equipment is maintained and calibrated to manufacturer and regulatory requirements.

Coordinate with external facilities maintenance teams and contractors for general and specialized repairs and maintenance.

Perform and support troubleshooting activities related to manufacturing and laboratory equipment and building utilities, such as mechanical, HVAC, electrical, and plumbing.

Support the operation of key facility utilities, such as WFI and Pure Steam Generation Systems, Water Distribution Systems, Process Gas Distribution, and other supporting utilities.

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; communicate facility constraints; propose/help 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.

Qualification

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GMP experienceMechanical knowledgeElectrical knowledgePlumbing knowledgeGMP documentationReport interpretationCalibrationEmergency handlingSafety focusEligibility to work in the USReal IDUS passportCommunicationProblem-solvingTeamworkAttention to detailBiotech Production Equipment KnowledgeBioreactorsAutoclavesPart WashersIncubatorsChromatography SystemsFiltration Systems

Required

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.

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.

Must be currently eligible to work in the United States without visa sponsorship and have lived in the United States for three of the past five years if a non-US citizen.

A Real ID or a U.S. passport is required to get on base at WRAIR.

Preferred

Working knowledge of common equipment found in a biotech production facility, including bioreactors, autoclaves, part washers, incubators, chromatography systems, filtration systems, etc., is preferred.