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Responsibilities

• Attend and support equipment FATs.
• Perform mechanical system walkdowns, verifying installation against design and client requirements.
• Identify technical, ergonomic, and operational defects during installation.
• Communicate defects and punchlist items to the General Contractor and subcontractors, verifying rectification.
• Communicate with Client Subject Matter Experts regarding redline drawings and technical issues.
• Verify as-build design documents and update drawings during walkdowns.
• Raise and closeout change control documentation for design modifications.
• Witness critical construction testing.
• Review turnover binders from contractors, including construction test packs and quality documents.
• Verify operation and maintenance turnover documentation, including manuals and spare parts lists.
• Execute Design Qualification, verifying client design against vendor documents.
• Raise issues to Client Subject Matter Experts during Design Qualification.
• Raise change controls and deviations during Design Qualification.
• Execute Installation Verification, including drawings, manuals, and maintenance documentation.
• Verify tagging, size, material, installation, and design compliance of critical components.
• Verify spare/change parts and preventative maintenance setup.
• Verify as-built drawings and design documents.
• Verify installation/construction testing and certification.
• Ensure activities, especially for direct impact systems, are leveragable.
• Execute Operational Verification, checking equipment operation including automated and manual functions.
• Complete tasks on or before scheduled dates.
• Report progress with accurate status and % completion.
• Clearly identify schedule risks.
• Identify and resolve schedule risks, verifying test prerequisites and support plans.
• Troubleshoot and resolve all issues.
• Discuss and resolve deviations, changes, design issues, and test failures with management and subject matter experts.
• Prepare and review risk assessments and method statements.
• Ensure safe handover of systems with LOTO, communication, and training.
• Plan and execute tests safely.
• Understand and follow Client procedures and policies.
• Report and investigate safety incidents.

Requirements

• Strong knowledge and experience of Commissioning and Qualification.
• Compliance with schedule at a system and area level with planned resource levels.
• Minimum 3 years of experience.
• Broad knowledge of engineering disciplines, commissioning, compliance, qualification, and quality aspects of biopharma or pharmaceutical manufacturing.

Skills

• Commissioning
• Qualification
• Quality
• HSE
• Operations
• Risk assessment
• Method statements
• LOTO
• Troubleshooting
• Communication

Experience Level

• Minimum 3 yrs.

Education Level

• Minimum BS or equivalent in Engineering or Science - preferably in Chemical, Mechanical or Pharmaceutical Engineering.