Job Description:
PROJECT ENGINEERING SUPPORT- Responsibilities include but are not limited to the following:
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 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 companyand 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.
- Include recommendations for ongoing monitoring and maintenance.