Olivia Jake Email & Phone Number

Irvine, CA, US

Hatboro, Pennsylvania, US

• Manages the Global Validation Program to ensure adherence to regulatory requirements and industry standards. Collaborates with a multi-discipline team including global and site-level representatives from Validation.
• Collaborates with a cross-functional team to implement and maintain standardized policies, procedures, and IQ/OQ/PQ templates to ensure consistency across the entire organization.
• Serves as a Quality core team member for new site development of ISO 7 cleanrooms and support areas. Provides Quality support spanning construction, commissioning, and qualification stages.
• Provides Quality guidance to the Global Engineering team to implement and maintain standardized policies, procedures, and templates regarding asset lifecycle to ensure consistency across the entire organization.
• Offers Quality Validation guidance to existing sites, including oversight and approval of site-level IQ/OQ/PQ protocols, executions, and reports.
• Managed a team of one employee, providing mentorship and training to ensure high-quality work output and professional development.

San Diego, California, US

• Responsible for planning, managing, and executing validation deliverables pertaining to equipment, facilities, utilities, and manufacturing processes. Collaborates with a multi-discipline team including Product.
• Plans and executes commissioning and validation projects from initial planning stages throughout execution, review, and approval of final reports.
• Authors validation documentation including Validation Plans, User Requirement Specifications, and IQ/OQ/PQ protocols.
• Serves as a supporting Validation Subject Matter Expert for Surface Mount Technology and Electroless Plating equipment and process validation. Authored Gage R&R protocol for Automated Optical Inspection system for.
• Serves as lead Validation Subject Matter Expert for Facilities IQ/OQ/PQ including Temperature Controlled Storage Units, HVAC, and Controlled Environmental Areas.
• Provides Validation project management support by leading weekly team meetings and participating in various multi-disciplinary project update meetings.

San Diego, CA, US

• Responsible for process validation deliverables pertaining to instrument new product introduction. Collaborated with a multi-discipline global team including Development, Engineering, Software, Quality, and.
• Collaborated with end users and process owners to lead development of validation strategy for projects, systems, and processes spanning sustaining manufacturing, introduction of new manufacturing processes, and.
• Managed individual validation projects from initial planning stages throughout execution, review, and completion/approval of final reports.
• Authored validation documentation related to manufacturing processes, systems, and test equipment including User Requirement Specifications, Functional Specifications, Configuration Specifications, IQ/OQ/PQ and PPQ.
• Provided Validation Subject Matter Expert support of product development deliverables outside the scope of validation including process FMEA, Test Method Characterization, and Gage R&R.
• Served as Area Training Representative for Lifecycle Management department. Collaborated with Training to overhaul and streamline training program for 50+ employees by implementing a role-based approach.

Cambridge, Massachusetts, US

• Assisted in selection, training, and development of junior engineering staff to effectively carry out department functions and provide for the continuity of specialized skills.
• Provided leadership, guidance, and direction to staff consistent with cGMP and company corporate quality governance.
• Responsible for leading Engineering projects by prioritizing work, developing work plans, assigning tasks to other engineers, and supervising cross-functional teams.
• Provided input into the department budget.
• Served as the liaison between Engineering and other functional groups, including Facilities, Validation, Quality and Manufacturing.
• Lead a group of engineers focused on engineering operations.

Cambridge, Massachusetts, US

• Responsible for the cross-functional planning and execution of projects pertaining to equipment, facilities, and utilities. Works collaboratively with team members from multiple functions including Facilities.
• Lead Engineering specification, estimating, design, procurement, programming, installation management, startup, commissioning, and documentation of new systems and the ongoing support of existing systems.
• Provided cost estimates for new systems and equipment, and modifications or upgrades to existing systems.
• Authored Engineering documentation related to new systems and equipment including User Requirement Specifications, Design Reviews, and Critical Aspects Risk Assessments.
• Served as point of contact for providing day to day engineering support for process equipment such as freezers, incubators, refrigerators, cryogenic storage, biosafety cabinets, etc. for critical site operations.
• Performed equipment failure investigations, root cause analysis, and developed CAPAs in the Trackwise Quality System.

Cambridge, Massachusetts, US

• Involved in the cross-functional planning and execution of projects pertaining to equipment, facilities, and utilities. Worked collaboratively with team members from multiple functions including Facilities Operations.
• Provided engineering support for new and existing process and utility system installations.
• Assisted with the specification, estimating, design, procurement, programming installation management, startup, commissioning and documentation of new systems, and the ongoing support of existing systems under close.
• Assisted in design reviews, construction, and installation support.
• Participated in validating systems inclusive of installation and operational qualifications by assisting in the preparation of complete engineering turnover packages.
• Participated in ongoing support of manufacturing equipment, facilities, and utility systems.