Engagement Manager

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.

General Project Support

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.

VALIDATION SUPPORT - Responsibilities include (but are not limited) to the following:

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.

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.

The pay range that the employer in good faith reasonably expects to pay for this position is $30.05/hour - $46.95/hour. Our benefits include medical, dental, vision and retirement benefits. Applications will be accepted on an ongoing basis.

Tundra Technical Solutions is among North America’s leading providers of Staffing and Consulting Services. Our success and our clients’ success are built on a foundation of service excellence. We are an equal opportunity employer, and we do not discriminate on the basis of race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability, genetic information, or other applicable legally protected characteristic. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Unincorporated LA County workers: we reasonably believe that criminal history may have a direct, adverse and negative relationship with the following job duties, potentially resulting in the withdrawal of a conditional offer of employment: client provided property, including hardware (both of which may include data) entrusted to you from theft, loss or damage; return all portable client computer hardware in your possession (including the data contained therein) upon completion of the assignment, and; maintain the confidentiality of client proprietary, confidential, or non-public information. In addition, job duties require access to secure and protected client information technology systems and related data security obligations.

Salary : $30 - $47