Senior Project Engineer

CSL; Liverpool City Region; On-site; GBP 70,000 - 90,000; Full time

Job summary

CSL in the United Kingdom seeks a Senior Project Engineer to lead scoping, delivery and cost control of capital projects at the Liverpool site, with emphasis on cGMP, EHS and business continuity.

You will oversee cross-functional teams through project lifecycle, ensure documentation, validation and handover, while maintaining site standards for GMP and safety.

Qualifications

• 5+ years practical and leadership experience in pharmaceutical industry.
• Knowledge of cGMPs and manufacturing operations in FDA regulated facility.
• Understanding of project management principles and lifecycle.
• Knowledge of Validation and facility regulatory submission requirements.

Responsibilities

• Create accurate and timely proposals for investment projects.
• Budget and schedule responsibility for multi-disciplinary GMP projects.
• Manage commissioning, qualification and handover processes with QA, production and maintenance.
• Ensure GMP, housekeeping, safety and discipline standards are maintained.

Skills

Leadership experience

Cross-functional collaboration

GMP awareness

Project management

Education

MSc/BSc/BA in Engineering or equivalent

Tools

FDA regulated facility experience

Validation

Capital project management

Job description

Senior Project Engineer

Reporting to the Senior Manager, Project Engineering, this is a senior technical role focussed on scoping, delivery and cost control of capital projects to meet the needs of the Liverpool site, including cGMP, EHS, business continuity, cost reduction and sustainability.

The role holder is expected to lead engineering projects involving cross functional teams and multiple GMP disciplines and uphold the prevailing site and CSL standards for cGMP, EHS, Project Management and Engineering.

The Opportunity

• Responsible for creating accurate and timely proposals for investment projects in accordance with departmental & CSL procedures, to ensure that projects can be submitted for approval in line with the capital expenditure plan


• Budget and schedule responsibility for approved multi-disciplinary GMP projects, including monitoring and reporting on the status of projects and cashflow forecasting in multiple formats. Accountable for meeting cashflow forecast as directed to support site expenditure targets, and for timely capitalisation of new fixed assets.


• Manages and participates in the commissioning, qualification and handover processes for capital projects in liaison with quality assurance, production management and maintenance functions, and ensures that all necessary training, drawings and documentation are provided for validation, operation and maintenance purposes.


• Ensures that appropriate standards of GMP, housekeeping, safety and discipline are maintained at all times both within the department and operational/construction areas

Your Skills and Experience

• MSc/BSc/BA in Engineering preferred or local equivalent


• 5+ years practical and leadership experience in pharmaceutical industry


• Functional knowledge of cGMPs and manufacturing operations in FDA regulated facility Pharmaceutical/biotech industry experience preferred


• Understanding of project management principles and project lifecycle phases


• Knowledge of Validation, and facility regulatory submission requirements