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Sr. Instrument Engineer

4 months ago

Durham, United States Cambrex Full time

Company InformationYou Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. Your Work Matters.At Cambrex, we strive to build a culture where all colleagues have the opportunity to:engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environmentstrengthen connections with coworkers and the communityWe're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company.We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and moreYour Future Matters.Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today Job OverviewThis role will oversee and support scheduling, tracking, and performance of work for the Metrology, Facilities, Validation, and Analytical Laboratory groups. This role will support the development of a corporate metrology program. The position will facilitate the accurate and timely scheduling of scheduled and on-demand instrument/equipment work events, as well as on-boarding of new equipment, processing requests for change, and managing any deviations (OOTs). ResponsibilitiesSupport the development of calibration and maintenance policies and procedures with a specific focus on analytical systems and instrumentationMentor and train junior members in relevant metrology and qualification activitiesCoordinate and lead meetings and sub team meetings as necessary and manage information flow and decisions in projects. Ensure the key stakeholders are informed of the timing of activities and their responsibilities related to the processEnter calibration, maintenance and/or validation events into the calibration database in an accurate & timely manner (with strong attention to detail) - Maintain calibration database for real-time accuracyObtain service quotes and scheduling offsite/onsite vendor calibrationsMaintain Spare Parts inventory and communicate effectively on time for any new spare parts requirementsProvide support/guidance to business owners regarding on-boarding of new equipment into the calibration management system databaseGenerate required documentation for new and existing instrumentsReview vendor calibration documentation and eventsEnter deviations/Out of Tolerance into deviation management systemEffectively demonstrate an understanding of cGMPs & how they apply to job-specific responsibilitiesFollow accurate oral and written procedures in performance of departmental tasksRemain current in industry best practices and regulatory guidance and implement sound, risk-based process improvementsSupport client and regulatory audits and serve as a metrology technical liaisonHelp drive a safety focused culture through implementation of safe processes and equipment Qualifications/Skills•Ability to work well in both in an individual and leadership capacities•Demonstrate organizational, leadership, and interpersonal skills working in a cross-functional, regulated environment•Knowledgeable in the functional operation of analytical systems (UPLC, GC-MS, HPLC, etc.). Experience with similar systems like Empower and Maximo is desired•Proficiency in calibration and troubleshooting disciplines covering the areas of pressure, temperature, torque, mass, thermometry, humidity, analytical, and DC & low frequency•Ability to execute PM / OQs for analytical systems•Ability to organize and prioritize work in order to meet established timeframes and schedules•Requires the ability to recognize problems and recommend solutions based on sound technical understanding of the process and equipment to prevent instrument failures and downtime•Must be able to effectively research information outside of current knowledge base•Requires the ability to recognize problems and recommend solutions based on sound technical understanding of the process and equipment•Knowledgeable in enterprise systems including Blue Mountain Regulatory Asset Management System, Rees Environmental Monitoring System, and Master Control Document Management System Education, Experience & Licensing RequirementsAssociate degree or higher in Engineering, Life Sciences, other related technical field or equivalent military training (PMEL etc.) and 10+ years of applicable (Metrology,Instrumentation, Calibration) experience or the equivalent combination of education and experience Supervision Received: General SupervisionExercises independent judgment in developing methods, techniques, and evaluation criteria for obtaining results. Acts independently to determine methods and procedures on new assignments. May seek management direction for problems of diverse and/or complex scope.Travel: Not ApplicablePhysical Demands:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision.Environment and Protective Equipment:The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to: safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.