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Quality Validation Engineer II (Critical systems)
Top 3 must haves:
Top Technical skills needed:
Option for role to be extended or going perm: No
Will they need to enter clean room? No
Any overtime, if yes how many hours: 10%
The Quality Engineer II provides engineering support to the plant through process optimization, risk management, validation, defect prevention, project management, and technical evaluations. This role ensures compliance with GMP/QSRs and all applicable standards related to product/process validation. The job contributes engineering/technical expertise through the Quality Management function to the manufacturing facility. The Quality Engineer’s duties not only include traditional work and projects, such as optimization, defect analysis, and prevention, and exception management, but also may encompass project engineering work as well, including the procurement of funding for capital investment, ROI analysis, research of the optimum equipment for the task, and implementation of that equipment. The Quality Engineer is accountable for the validation process. The job requires basic engineering skills, statistical/six sigma skills, numerical analysis techniques and implementation skills for process improvement. Knowledge of all validation phases is a must, from the conception of the project to the final signature.
The Critical Systems Engineer should have adequate knowledge of some or all of Process Compressed Gas systems, HVAC systems for controlled environments and subsequent monitoring, as well as compendia water purification systems. A basic understanding of microbiology and potential contamination sources and vectors is a must. Additional areas of knowledge and experience should include terminal sterilization and pest control. Interfacing with outside regulators and auditors may be required.
Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned):
• Leads or assists in developing and implementing new machines/processes and in improvements to existing methods. Requirements for new/improved machines/processes, including system requirements/ design specification, risk analysis; installation qualification, operational qualifications, and performance qualification are all in the scope of the Quality Engineer. This requires interfacing with local Quality, Production, and Engineering as well as Corporate Engineering, Quality, and Regulatory functions.
• Supports the manufacturing plant through implementation of process improvements.
• Conducts process/financial analysis through conventional methods of ROI, quality trending/tools, VIP measurements and implements/drives improvements.
• Manage small projects (both new and improvement) to include cost, implementation, and validation.
• Provides statistical assistance to Quality and Production.
• Evaluates sampling/ testing/ qualification plans with respect to current quality levels and test methods.
• Accountable for the testing required in conjunction with protocols, in-process risk assessment, and situation appraisal.
• Composes protocols, final reports, studies, experiments, and general information reports for use by management.
• Leads/coordinates validation efforts of new equipment and changes to existing equipment.
• Assist in evaluation of customer complaints, risk management and technical summaries.
• Assist in evaluation of supplier product/process changes.
• Assure compliance of manufacturing and quality control operations with respect to corporate specifications, SOP’s, Good Manufacturing Practices/Quality System Regulations (FDA 21CFR 820), Corporate Quality Manual (CQM), ISO 13485-2003, Canadian Medical Device Requirements (CMDR), MDD 93/42/EEC and other applicable standards and regulations.
• Implements a basic knowledge of engineering, statistical/six sigma tools and associated methods into the analysis of processes for identification of potential opportunities of improvement.
• Supports and may own execution of CAPA investigations with use of DMAIC process and technical writing skills.
• Excellent Technical writing skills, especially as it relates to the CAPA/Complaint process and the actions associated with those activities.
• Understanding and knowledge of various international standards relating to a variety of topics, as needed (i.e. ASTM, ASRAE, ANSI, AAMI, ISO standards applicable to scope of work)
• Responsible for:
o Initiating action to prevent the occurrence of any nonconformities relating to product, process, and quality system.
o Identifying and recording any problems relating to the product, process and quality system.
o Initiating and implementing solutions through designated channels.
o Establishing controls on a process and establishment of the verification/monitoring of such.
o Driving improvements into the production process, from conception to sustainable production methods.
Job Requirements (Education, Experience and Qualifications):
• Minimum 2 years’ experience in regulated manufacturing environment
• BS degree in Engineering preferred, Engineering Technology/ Microbiology/Chemistry degree may be acceptable depending on experience.
• Strong technical writing and investigation skills required.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, POMs, Maximo etc.
• Familiarity with MINITAB preferred
Physical / Safety Requirements
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position requires standing and walking for extended periods of time
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