We are seeking a Senior Engineering and Facilities Manager to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland. 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
Exhibits effective team leadership, team communication, and facilities staff development.
Leads and tracks E&F project status, updates site monthly at All-hands meetings and conveys E&F Quality metrics at Quarterly Management Reviews.
Delegates to and manages a team of qualified individuals to assess and implement solutions focused on increasing available facility/production line capacity.
Implements systems for tracking engineering project progress and conducts working meetings to drive execution and meet OTA goals.
Administers, expands, and validates PBF FactoryTalk-based Environmental Systems Monitoring system.
Applies and follows Quality Assurance compliance guidance, including current Good Manufacturing Procedures (cGMP) and ICH guidelines.
Authors and supports the development of URS, FDS, SAT, and SOP and Commissioning documentation where applicable to drive mission compliance and OTA goals.
Optimizes facility capacity through coordination, communication, planning, and execution of shutdown activities.
Supports VHP operations in coordination with other departments as directed by area leads and program management.
Specifies and enforces PBF engineering standards for all new equipment and supports area owners in facility-related user requirement development.
Maintains equipment as-built documentation, and oversees change controls for the facility, equipment, and ESM systems.
Schedules, orders, oversees, and directs bioprocessing systems repair and maintenance activities with Army personnel or outside contractors as needed.
Interfaces 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.
Conducts market research for outside contracting services and new equipment.
Supports site continuous improvement initiatives.
Reviews change controls and performs engineering impact assessments as required.
Supports failure investigations as required.
Responds to ESM, BMS, and Datatron system alarms as required.
Maintains a safe workplace, ensuring awareness of and observance of appropriate safety and occupational health rules and regulations.
Performs other tasks as directed by CAMRIS leadership.
Qualifications
Required
A BS degree in engineering or a related field and 20 years of experience, or a master's degree and 16 years of experience, or a doctoral degree and 12 years of experience in a cGMP biotechnology, pharmaceutical, or related facility.
10+ years of experience supporting site operations, 5+ years in a team supervisor or in a managerial role.
Experience working in highly regulated industries, such as life sciences, food, and nuclear preferred.
Excellent communication skills and experience working in a multi-discipline and diverse team structure.
A demonstrated aptitude for problem-solving and resolution.
Familiarity/knowledge of cleanrooms and cleanroom requirements. Work may involve the need for aseptic gowning.
Technical understanding of clean water and steam systems.
Technical understanding of automation technology and infrastructure, including the following examples:
Communication Protocols (i.e., Ethernet IP, Modbus, Profibus, MQTT, BACnet, OPC).
IT Infrastructure (Servers, Switches, Network Distribution).
Windows and Linux Operating System.
SQL Server or other supporting data management systems.
Must have eligibility to work in the United States and have lived in the United States for three of the past five years if a non-US citizen.
Preferred
Knowledge of DoD and DHS networking and ATO accreditation.
Proficient in the general use of various types of office software: Outlook, Word, Excel, MS Project, or LIMS experience a plus.
Membership in professional organization(s), such as ISPE, ISA, or IEEE, and/or familiarity with their standards.
Familiarity/knowledge of building/equipment monitoring systems.
Excellent customer service, interpersonal, and communication skills.
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.
CAMRIS offers a comprehensive benefits package to support your health, well-being, and financial security. Our offerings include medical, dental, and vision insurance, FSAs and HSA, life and disability coverage, retirement plans with employer match, tuition reimbursement, public transportation support in the DMV area, and generous paid time off. Additional benefits include legal services, pet insurance, and an employee referral bonus program.
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 Public Trust-level 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.
