Cleveland | Ohio | United States | 44128
This Senior Manager level position is responsible for overseeing all activities related to designing and implementing manufacturing processes, and/or new equipment within the manufacturing environment. Position has oversight of all validation and verification activities in compliance with cGMP regulations. The role will have responsibility for the successful implementation of any new filling and packaging processes within the manufacturing area. Engineers reporting to this Senior Manager will work on various process improvement projects from packaging line upgrades to equipment/systems related to new product launches.
Manage and direct individuals assigned to process driven initiatives related to packing and filling products
Ensures all process engineering work is in complete with FDA requirements and follows Good manufacturing Practices and International Organization for Standards requirements
Mentors team of Process Engineers
Manage and guide efforts towards on-time design and execution of Process Validation Requirements
Ensure ECR/ECO process is understood and followed for all Engineering Changes
Works closely with Quality and Regulatory groups to ensure all Engineering and process Changes are compliant with Quality Management System
Develop implement improved validation policies
Work closely with manufacturing and engineering personnel to develop and maintain the required preventative maintenance plans for all equipment
Prepare, review, and approve process and packaging validation protocolors and reports
Bachelors Degree in Mechanical or Bio-Medical Engineering or other related discipline
10-15 years of reliated experience in the medical device or pharmaceutical industry
5-7 years experience leading an Engineering Process Improvement/Validation team in an FDA environment
Strong knowledge of GMP, FDA, and ISO requirements
Background in writing and performing Installation Qualification, Operation Qualification, and Performance Qualification protocols and documents
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HRU has developed a large network of available candidates nationwide, as the company has been providing recruiting and staffing services in up to 22 States for over 25 years. We specialize in engineering, IT, technical and other support services. We are able to recruit and successfully place candidates in job openings in a variety of other fields and positions as well, such as human resources, administration, management, purchasing, sales, customer service, accounting, organic chemistry and more. HRU is able to service clients, regardless of location, by assigning an Account Manager and experienced Recruiters to provide the necessary staffing and support services. Likewise, HRU may assist job seekers anywhere in the United States, regardless of location.
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