Engagement Manager

Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented Team.

Job Title: Engagement Manager

Location(s): Los Angeles, CA

• Highly skilled and experienced in authoring / review of validation documentation such as URS, FRS, and SDS, Validation Plan, Training Plan, Issues Log, Design Review, IQ Protocol/Report, OQ Protocol/Report, PQ Protocol/Report, Test Cases, Test Incidents, Trace Matrix, and Validation report, etc.
• Ability to identify, analyze and mitigate validation project risks. skills.
• Comfortable and professional engagement with senior leadership, Client Managers, and multi-location teams.

• Attend Weekly Project Meetings.
• Attend Daily Construction Meetings.
• Attend Monthly EH&S Safety Meeting.
• Generate Work Orders.
• Generate Memos / Interoffice Correspondence.
• Generate Meeting Minutes.
• Generation and Modification of project lifecycle documentation for LA Plant Site.
  
  
  
  • User Requirement Specifications.
  • Functional Specifications.
  • Design Specifications.
  • SOPs.
  • Management of Change (MOC).
  • FMEA.
  • HAZOPs.
  • Risk Assessments.
  • Gap Assessments.
  • Project Closeout Documentation.
  • Turnover Package Generation.
  • Project Change Requests.
  
  
  
  
• Management of Project Change Control Records (PRs).
  
  
  
  • Generate/Initiate.
  • Manage.
  • Close.
  
  
  
  
• Support Takeda and A/E Firm in Project Design.
  
  
  
  • Conceptual Design.
  • Basic Design.
  • Detailed Design.
  • Design Review.
  
  
  
  
• Construction Activities.
  
  
  
  • Generate and Manage Safety Management Plans and Documentation.
  • Disruptive Construction Activity Requests.
  • Job Hazard Analysis.
  • Lockout Tag Out Plan.
  • Hot Work Permitting.
  • Permit to Work.
  • Detour Plans.
  • Construction Signage.
  • Plant-wide Communications.
  • Generate and Manage Quality Management Plans and Documentation.
  • Construction Control Plan.
  • Assist in site supervision of construction personnel.
  
  
  
  
• Manage Installation and Operational Commissioning
  
  
  
  • Author and Approve.
  • Execution.
  • Function Testing.
  • BOM Updates.
  • PM Generation.
  • Asset Lifecycle.
  • Drawing Updates.
  • Support site acceptance testing to review system documents and functions during SAT.
  • Summary Report.
  
  
  
  
• Manage Installation, Operational, and Performance Qualification.
  
  
  
  • Author and approve.
  • Develop and execute qualification protocols.
  • Assist with any deviation resolution and handling.
  • Execution.
  
  
  
  
• Summary Report Training and Documentation.
  
  
  
  • Train personnel on the operation of the Fractionation process, and related procedures.
  • Create comprehensive documentation of all validation activities.
  
  
  
  
• Risk Assessment and Mitigation.
  
  
  
  • Identify and assess potential risks to product quality and patient safety.
  • Develop mitigation strategies and contingency plans.
  
  
  
  
• Change Control.
  
  
  
  • Manage change control for any modifications or updates to the equipment or processes.
  
  
  
  
• Quality Audits.
  
  
  
  • Conduct internal and external audits to ensure compliance with quality standards and regulations.
  
  
  
  
• Start up support.
  
  
  
  • Start up support for process equipment and facility as required.
  
  
  
  

• Installation Qualification.
  
  
  
  • Equipment installation verification and confirmation that equipment is installed in Accordance with manufacturer's specifications.
  • Document equipment installation and location.
  
  
  
  
• Operational Qualification.
  
  
  
  • Equipment functional verifications under operational conditions.
  • Conduct testing of equipment functionality and performance.
  • Documenting of all test results and deviations.
  
  
  
  
• Performance Qualification.
  
  
  
  • Confirmation of the fractionation performance.
  • Validate the manufacturing process and critical process parameters.
  • Generate and review batch records and documentation.
  
  
  
  
• Process Validation.
  
  
  
  • Conduct process validation studies to ensure consistent product quality.
  • Perform risk assessments and implement process controls.
  • Develop and validate analytical methods for product testing.
  
  
  
  
• Cleaning Validation.
  
  
  
  • Validate the cleaning procedures for the equipment to prevent cross contamination.
  • Document cleaning validation protocols and results.
  
  
  
  
• Facility Qualification.
  
  
  
  • Conduct validation of critical facility systems.
  
  
  
  
• Software Validation.
  
  
  
  • Validate any software system used in the fractionation process, including data management and process control systems.
  
  
  
  
• Validation Reports.
  
  
  
  • Compile validation reports summarizing all activities, results, and conclusions.