Senior Quality Engineer
📋 Role Overview & Responsibilities
Job Title: CQV Engineer on W2Location: Thousand Oaks, CADuration: 12 Months
Description:Ideal Candidate: minimum chemical, mechanical, Biomedical*** Bachelor degree and 5 years of experience, Masters and 3 years of experience. Quality and validation experience process and system ownership in pharma, works directly in a regulating environment and manufacturing. Leadership roles Project ownership, taking charge and saw through to completion, Team leads. Experienced, Quality Management Systems, Maximo, Validating QC instruments.
This engineering position supports manufacturing activities associated with cGMP equipment and facilities at Thousand Oaks (ATO). The Senior engineer will lead activities in alignment with Commissioning and Qualification Process (CQP) to ensure that new GMP equipment is installed and maintained in a validated state. This role will collaborate with the maintenance, project management, the engineering technical lead, and manufacturing to develop and oversee the implementation, operation and reliability of equipment. The senior engineer will work closely with Quality Assurance (QA) to ensure GMP compliance and address potential gaps. In addition, the senior engineer will evaluate equipment maintenance plans, support periodic review of manufacturing systems, and lead root cause investigations of equipment issues. The senior engineer will support the projects in defining strategies for quality systems verification and will work with the process development / validation team to develop and document appropriate practices for characterization. This role will lead other engineers in root cause analysis, project management, with a safety-oriented mindset.Basic QualificationsDoctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
Top 3 Must Have Skill Sets:• Demonstrated strong communication and technical writing skills with cross functional groups, (QA, MFG., Leadership)• Direct experience with regulated environments (FDA, OSHA) with an emphasis in promoting safety and quality in their area of work.• Bachelor's degree in engineering or another science-related field with 5+ years of relevant work experience in operations/manufacturing environment
Rupalim DuttaTeam Leadrupalimd@aditiconsulting.com(650) 376-0819
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This position is located in Thousand Oaks, CA with potential relocation and sponsorship assistance depending on candidate qualifications.
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