Project Manager, Senior Validation and Quality Engineer

Location: Irvine, CA

Job Description

Responsible for managing projects and a team of engineers at client locations. Supervise and coach junior process and validation engineers. Provide consultation and assistance to client and team members on validation / qualification, including activities such protocol / report drafting (using perform statistical analysis) and change management. Report results, progress, and data and create defect reports. Perform technical project management such as developing technical approaches, developing project implementation methodologies, monitoring project compliance with appropriate design plans and schedules; lead, direct and develop company personnel through all technical aspects of the project lifecycle; communicate effectively verbally and in writing with project team members regarding project plans, roles and responsibilities and the scope of work for each project. Review equipment, cleaning and process and/or facilities validation documents. Author engineering documentation such AS URS/FS/DS; develop, modify and execute complex test procedures for equipment, production, facilities and quality (FAT, SAT, IQ, OQ, PQ, PPQ); perform and check engineering analysis related to process optimization using engineering tools. Write reports to summarize validation/verification/commissioning and/or re-validation/ verification/ commissioning activities; support the resolution of regulatory observations or manufacturing site issues. In addition, provide technical understanding to support business development planning. Identify different growth plans and conduct technical capabilities review to support expansion planning. Monitor profit and loss centers to increase revenue. As part of business development, understand technical requirements in the industry and develop marketing material, planning tradeshows and identifying key clients to support growth.

Must have experience in engineering/validation field in pharmaceutical, medical device or biotech industry with management experience and/or a suitable management educational qualification. Strong working knowledge of FDA and cGMP regulations and good documentation practices. Excellent written and verbal communication and technical writing skills. Proficient in MicroSoft Office Suite, Minitab, ERP software (JDE, etc.). Hands-on experience, familiar with industry concepts, practice and procedures in a cGMP environment. Experience with design documentation (URS, FS, DS and other engineering specifications, DOE); validation (IQ, OQ, PQ, PV etc.); quality systems (change control, deviations, corrective actions & preventive actions, re-qualification, etc.). Management experience in technology transfer projects. Strong background in facilities & critical utilities engineering (facility decommissioning, WFI, CSM, RO, HVAC, CCA, CHWS) and operations support. This position requires limited travel to client sites in Orange county California and may require travel to client sites in southern California. Understand industry technical needs in the market and strategize team training and development by through technical skill set development. Manage project timelines, budget and team resourcing. Provide management training to support technical deliverables.

This position requires limited travel to client sites in Orange County California and may require  travel to undetermined client sites in Southern California.

Requirements:  MBA in Engineering Management with 48 months professional work experience as Validation Engineer or Quality Assurance Analyst.    
Job interview:  Irvine, CA. This is a full-time position and is located in the Orange County, CA area.