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|Job Category :||Engineering|
|Company Name:||Charles River Laboratories|
|Position Name:||Director, Facilities & Central Services|
|Location :||Rockville, MD 20850|
|Job Description :||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. Job Summary The 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 & Responsibilities Design, 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 authorities.Maintain all clinical manufacturing sites in a state of control for cGMP operations.Develop and implement a comprehensive engineering, maintenance, and facility strategy for multiple buildings as well as the supporting policies and procedures.Partner 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 spaces.Plan, develop, and lead capital investment projects for new lab and GMP manufacturing capabilities.Act as SME for selection, purchase, and installation of equipment, utilities, and facilities for biologics manufacturing.Ensure that critical GMP utilities/systems are properly setup, validated, calibrated, operated, and maintained.Act as SME for review, approval, and updating of critical building documentation and drawings.Develop 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 utilities.Develop, 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 contracts.Oversee design specification, GMP service contracts negotiation, timelines, and execution of numerous GMP-related projects to enhance and maintain the facilities.Ensure that appropriate Business Continuity Planning, Emergency Coordination, and Risk Management procedures are in place.Direct on time and compliant creation and closure of departmental Change Controls, Risk assessment, Deviations, investigations and CAPA activities.Manage the company’s Environmental Health and Safety (EHS) Program, including chemical safety, incident reporting, hazard analysis, training, regulatory compliance, and safety auditing.Manage Facilities & Engineering Manager, Facilities Equipment Manager, Engineering & Validation Manager, Environmental Health & Safety Specialist, and their Engineers and Associates.Other responsibilities as needed. Job Qualifications B.S. in Engineering, Science or related field required; M.S. preferred.8+ 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 environment.Knowledge of Biologics manufacturing and aseptic fill finish processes.Demonstrated leadership skills in directing facilities and engineering support cGMP operations.Direct experience supporting manufacturing facilities and utility systems within an FDA and EMA regulated environment.Subject matter expert in describing and defending GMP facilities, equipment, and utility systems in audit settings.Experience in environmental Health and Safety with OSHA certification.Expertise in GMP facility design and operation, equipment, utility, and cleanroom design, operation, qualification, and maintenance.Extensive knowledge of industry standards for commissioning, validation, and operation of facilities and utilities for GMP manufacturing and GXP laboratories. Vaccine Mandate Charles River is a U.S. 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@crl.com) so that information can be provided about the accommodation process at Charles River. About Biologics Testing Solutions With 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.|