Validation Engineer
3 weeks ago
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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