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
