Senior Engineer

3 weeks ago

Thousand Oaks, United States Infotree Global Solutions Full time

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 Client Thousand Oaks (ATO). The Senior engineer will lead activities in alignment with Clients 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. 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

Day to Day Responsibilities: The Engineer role will provide direct engineering technical support as follows: Be individually accountable for deliverables on key capital projects. This may include rationale development for improvements and identification of design requirement. In addition, translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment. Providing problem solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action Lead in the identification of critical quality parameters and process attributes for new equipment or facility modifications. Oversee and assist with development and execution of validation protocols in line with CQP and cGMP standards. Lead, evaluate, and manage performance of contract resources. Provide oversight for verification deliverables developed by outsourced/contract verification staff. Act as a liaison between Engineering, Manufacturing, and Quality Assurance during project planning, execution, and closeout. Lead and assist other engineers with troubleshooting, maintenance, and project management. Ensure safety during commissioning, validation, maintenance, and manufacturing activities. Review and approve the commissioning report and ensure that all validation exceptions have been adequately addressed. Conduct and document periodic equipment validation reviews. Provide ad hoc technical support and guidance for manufacturing and maintenance Perform equipment troubleshooting and root cause investigations using LEAN tools (Fishbone, 5-Why, etc.) Participate in internal audits and assess risks in conjunction with QA. Develop and maintaining metrics related to equipment performance Triage and Own Deviations as well as lead team on quality based decisions

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