The Project Engineer will support the delivery of a pharmaceutical capital project involving the design, construction, and commissioning of a packing hall and warehouse facility. The role is responsible for delivering defined engineering scopes across both equipment systems and facility/utilities infrastructure, with a focus on mechanical building services and live site tie‑ins. The position ensures safe execution on a live GMP site, maintaining compliance with GMP, EHS, and regulatory requirements, and supporting effective handover to operations. This role is suited to an engineer with experience in capital projects who can own technical workstreams while collaborating with senior engineers and cross‑functional stakeholders.
Key Responsibilities
Facilities, Utilities & Live Site Tie‑Ins (Mechanical Bias)
- Lead and support engineering activities related to mechanical utility systems, including HVAC, heating/cooling systems, compressed air, water systems, and drainage.
- Plan, coordinate, and execute live site utility tie‑ins, isolations, and cut‑overs to existing systems, minimising disruption to operations.
- Develop and review tie‑in strategies, method statements, and sequencing plans for works on a live GMP site.
- Coordinate interfaces between new and existing buildings, utilities, and infrastructure.
Equipment Engineering & Delivery
- Develop and review User Requirement Specifications (URS) and equipment specifications for packaging, material handling, and warehouse systems.
- Support procurement activities, including RFQs, technical bid evaluations, and supplier clarifications.
- Act as a technical interface with equipment suppliers.
- Review and approve vendor documentation, including drawings, FAT protocols, test results, and O&M manuals.
- Support installation, commissioning, and Site Acceptance Testing (SAT) of equipment systems.
Engineering & Design Delivery
- Review and manage engineering deliverables, including layouts, schematics, calculations, and technical documentation.
- Ensure designs meet GMP, GDP, EHS, and regulatory requirements (e.g. MHRA, FDA, EudraLex).
- Participate in design reviews, constructability reviews, and risk assessments (e.g. HAZID/HAZOP, GMP impact).
Construction, Installation & Commissioning
- Provide engineering support during construction and installation of equipment and utility systems.
- Coordinate works with contractors and operations to ensure safe execution on a live site.
- Resolve technical issues arising during installation and commissioning.
- Plan and support commissioning and SAT activities, ensuring systems are ready for qualification and operation.
GMP, Quality & Validation
- Ensure all engineering activities comply with GMP, GDP, EudraLex, and company quality systems.
- Support qualification and validation activities, including DQ, IQ, and OQ.
- Participate in GMP impact assessments, deviation management, and change control.
- Contribute to documentation required for audits and regulatory inspections.
Project & Stakeholder Support
- Manage assigned engineering deliverables, actions, and milestones in line with the project schedule.
- Support the Project Manager with planning, technical decisions, risk management, and change control.
- Coordinate with stakeholders including Operations, Packaging, Warehouse, Quality, Validation, EHS, Automation, and Maintenance.
- Support handover to operations, including as‑built drawings, O&M manuals, and training inputs.
Qualifications
- Degree in an engineering discipline or equivalent experience supporting capital projects
- Proven experience supporting pharmaceutical capital projects in a GMP‑regulated environment.
- Experience with equipment specification, procurement support, installation, and commissioning.
- Experience with facilities/utilities and building services, including live site tie-ins, is highly desirable.
Technical Skills
- Good working knowledge of GMP, GDP, and pharmaceutical engineering standards.
- Experience reviewing supplier documentation and managing technical interfaces.
- Understanding of qualification and validation requirements within pharma projects Personal Attributes
- Able to work autonomously within a defined scope while escalating appropriately.
- Confident working in a live operational site environment with high safety standards.
- Strong organisational skills with good attention to detail.
- Effective communicator, able to work with suppliers, contractors, and cross‑functional teams.
- Comfortable working in a fast‑paced, site‑based project environment.