Director, Facilities & Central Services

Employer
Charles River Laboratories
Location
Rockville, MD
Posted
Jan 13, 2022
Closes
Jan 16, 2022
Ref
311967886
Hours
Full Time
For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about.IMPORTANT: In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process. Please make sure work history and education are added correctly.Job SummaryThe Director, Facilities & Engineering - GMP Manufacturing, will direct, manage, maintain, expand, and update the process development, clinical manufacturing, and administrative buildings for all sites of Vigene Biosciences, A Charles River Company. Leads the teams that manage the IT infrastructure, PD and GMP equipment, Clinical Manufacturing, Quality Control, and Process Development laboratories, administrative building, EH&S, security, janitorial activities, and associated contractors to achieve GMP compliance. Acts as project lead on all capital projects.Duties & ResponsibilitiesDesign, build, and validate facility and associated manufacturing and quality systems suitable for clinical phase 2 and 3 manufacturing, pre-positioned to be commercially compliant, inspection ready and licensable by USFDA and EMA health authoritiesMaintain all clinical manufacturing sites in a state of control for cGMP operationsDevelop and implement a comprehensive engineering, maintenance, and facility strategy for multiple buildings as well as the supporting policies and proceduresPartner with key stakeholders including Manufacturing, Technology Transfer and Support, Process Development, and Quality to meet user requirements and optimal functioning of all manufacturing, laboratory, and building spacesPlan, develop, and lead capital investment projects for new lab and GMP manufacturing capabilitiesAct as SME for selection, purchase, and installation of equipment, utilities, and facilities for biologics manufacturingEnsure that critical GMP utilities/systems are properly setup, validated, calibrated, operated, and maintainedAct as SME for review, approval, and updating of critical building documentation and drawingsDevelop and maintain a comprehensive GMP facilities, equipment, and utilities master plan to optimize space and resources and to maintain uptime of the critical GMP equipment, facilities, and utilitiesDevelop, lead, and deliver maintenance and calibration process improvements by identifying and implementing robust preventive maintenance programs for equipment and utilities required for meeting company objectives. Manage service contractsOversee design specification, GMP service contracts negotiation, timelines, and execution of numerous GMP-related projects to enhance and maintain the facilitiesEnsure that appropriate Business Continuity Planning, Emergency Coordination, and Risk Management procedures are in placeDirect on time and compliant creation and closure of departmental Change Controls, Risk assessment, Deviations, investigations and CAPA activitiesManage the company's Environmental Health and Safety (EHS) Program, including chemical safety, incident reporting, hazard analysis, training, regulatory compliance, and safety auditingManage Facilities & Engineering Manager, Facilities Equipment Manager, Engineering & Validation Manager, Environmental Health & Safety Specialist, and their Engineers and AssociatesOther responsibilities as neededJob QualificationsB.S. in Engineering, Science or related field required; MS preferred8+ years of experience in a functional leadership position within one or more areas including Process Engineering, Facilities/Engineering Maintenance, Automation/I&C Engineering, Validation, or related functions preferably in pharmaceutical manufacturing environmentKnowledge of Biologics manufacturing and aseptic fill finish processesDemonstrated leadership skills in directing facilities and engineering support cGMP operationsDirect experience supporting manufacturing facilities and utility systems within an FDA and EMA regulated environmentSubject matter expert in describing and defending GMP facilities, equipment, and utility systems in audit settingsExperience in environmental Health and Safety with OSHA certificationExpertise in GMP facility design and operation, equipment, utility, and cleanroom design, operation, qualification, and maintenanceExtensive knowledge of industry standards for commissioning, validation, and operation of facilities and utilities for GMP manufacturing and GXP laboratoriesIMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV.Vaccine MandateCharles River is a US Federal Contractor. As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19 by December 8, 2021. Our main priority is the wellbeing, health, and safety of our people. We will be requiring proof of vaccination from all employees.Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition (crrecruitment_US@) so that information can be provided about the accommodation process at Charles River.About Biologics Testing SolutionsWith more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.

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