Overcoming capital risk through integrated facility engineering.

A primary operational liability for emerging biopharma innovators and established pharmaceutical manufacturers alike is managing the handoffs between independent design architects, construction contractors, and qualification teams.

When a facility's layout is engineered without comprehensive pharmaceutical facility design strategies or deep regulatory insight, significant issues frequently emerge during the physical build. These include cross-contamination risks in material flows, non-compliant cleanroom pressure cascades, or utility systems that fail to meet high-stakes health authority standards.

PLG systematically eliminates these costly disconnects. By combining advanced pharma engineering consulting with specialised GxP qualification consulting, we bridge the gap between initial spatial design and long-term facility validation.

Whether you are executing a complex greenfield build, expanding an active facility's capacity, or re-qualifying a manufacturing site for a new product line, our unified approach ensures complete technical rigour, operational efficiency, and a faster path to commercial production.

 

Services

Technical Capabilities Across the Asset Lifecycle

 

Our Engineering Centre of Excellence provides comprehensive technical direction and operational oversight across two core service divisions.

Engineering Design and Construction
Engineering design and construction

Our Define. Design. Deliver. methodology covers everything from preliminary consulting, assessments, and feasibility, through conceptual, basic, and detail/executive design, to EPC/EPCM delivery.

next-arrow
GxP qualification and maintenance services
GxP qualification and maintenance services

We provide comprehensive GxP qualification, data compliance, and ongoing site energy, waste, and maintenance services.

next-arrow
leadership-img

Engineering

Susan Maue
BU Managing Director

 

"A facility is a regulatory commitment long before it produces its first batch.

Every layout choice, every utility, every airflow decision will eventually be read by an inspector.

For more than 20 years, our engineers have designed with that inspection in mind, from first feasibility study to final qualification.

Define. Design. Deliver. is how we make sure compliance is built into the walls, not added afterwards."

 

Frequently asked questions

PLG's Engineering Centre of Excellence designs and builds GxP facilities for pharmaceutical and biotech companies. Services fall into two divisions: Engineering Design and Construction, from feasibility to EPC/EPCM delivery, and GxP Qualification and Maintenance Services, covering qualification, data compliance and ongoing site energy, waste and maintenance management.

It is PLG's three-phase approach to facility projects. Define covers preliminary consulting, assessments and feasibility. Design covers conceptual, basic and detailed/executive engineering. Deliver covers EPC/EPCM execution through to qualification. Compliance is built into every stage, so the facility is designed to pass health authority inspections from day one.

Under EPC (Engineering, Procurement and Construction), one contractor delivers the facility turnkey and carries most of the delivery risk. Under EPCM (Engineering, Procurement and Construction Management), the contractor manages design, procurement and construction on the owner's behalf, and the owner keeps more control over contracts and costs. PLG delivers both models.

By designing with the inspection in mind from the first feasibility study. Material and personnel flows, cleanroom classification and pressure cascades, HVAC and utility systems are engineered against GMP requirements, then verified through formal qualification. This avoids the costly redesigns that occur when compliance is checked only at the end.

Yes. PLG supports greenfield builds, capacity expansions of active facilities and re-qualification of manufacturing sites for new product lines. Its maintenance services also cover day-to-day site operations, including energy and waste management, to keep facilities compliant and efficient after start-up.

GxP qualification provides documented evidence that facilities, utilities and equipment are fit for their intended use. It typically follows a risk-based sequence of design, installation, operational and performance qualification (DQ, IQ, OQ, PQ). PLG also covers data compliance for the computerised systems that control and record manufacturing.

PLG's Engineering Centre of Excellence has delivered life sciences design and construction projects for over 20 years. Because it sits within a group that also covers regulatory, quality and digital services, engineering decisions are made with the full regulatory and operational picture in view.