Validation Engineer

3 weeks ago


Minneapolis, United States EPM Scientific Full time

Summary: A leading biotech company based in Minneapolis, MN is looking to bring on a Validation Engineer on a contractual basis. As Validation Engineer, you will lead validation and quality engineering activities for internally manufactured products, including validation plans, protocols and reports, maintenance of DMR, change control, and CAPA/Deviation investigations. This position is the owner of the process validation system including being responsible for developing/maintaining procedures and policies by regulatory requirements/industry standards. Knowledge/Experience Needed: Formulate validation plans, protocols, and reports for assembly and packaging procedures Manage the development and adherence to validation standard operating procedures in alignment with regulatory guidelines Create and update validation protocol and report templates Develop protocols and reports for the validation of test methods, both automated and manual inspection techniques Offer quality engineering assistance for the development of semi-manual and automated equipment Assess equipment User Requirement Specifications (URS), Factory Acceptance Testing (FAT), and Site Acceptance Testing (SAT) against quality standards Assist in the transfer of internal manufacturing processes during the design phase Conduct statistical analyses on validation and production data Support the development and qualification of manufacturing processes for product modifications Identify and contribute to continuous improvement initiatives Lead investigations and reporting on Corrective and Preventive Actions (CAPA), Non-Conformance Reports (NCR), and Supplier Corrective Action Requests (SCAR) Provide support for both internal and external audits Assist in investigations related to customer complaints Contribute to the development of the quality management system as needed Review supplier documentation to ensure compliance with established requirements Cultivate strong collaborative relationships with cross-functional team members to ensure the safety of patients/users and meet business objectives Perform additional duties as assigned Qualifications: Bachelor's degree in Engineering or a related science At least 5+ years relevant experience within the medical device industry or related function Knowledge of GMP, ISO, QSR, and other applicable international regulations Proven track record of working with CAPA/SCAR/NCR investigations and reports Experienced with participation in audits Good statistical data analysis skills (Minitab) Background in manufacturing processes for sterile pharmaceutical products and drug-device combination products related to development and commercial programs a plus Design for Six Sigma and Critical to Quality training and experience a plus Experienced with participation in audits ASQ certification a plus

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