Company Overview
An established international pharmaceutical manufacturer and development partner with decades of experience in the production of Active Pharmaceutical Ingredients (APIs) supports both human and animal health sectors. The organization specializes in complex chemical synthesis and high-potency compounds, operating GMP-compliant manufacturing facilities with advanced containment technologies and continuous investment in process innovation and plant expansion.
The business provides services including custom synthesis, process development, analytical support, manufacturing scale-up, and regulatory compliance support to global pharmaceutical partners.
Role Overview
The successful candidate will join the technical engineering function, reporting into senior engineering leadership. The role focuses on the design, optimization, maintenance, and continuous improvement of chemical-pharmaceutical manufacturing facilities while ensuring compliance with quality, environmental, safety, and GMP standards.
The position requires close collaboration with Production, Quality, HSE, Regulatory Affairs, and R&D teams to support plant reliability, operational efficiency, and manufacturing continuity within a highly regulated industrial environment involving complex batch processes and advanced containment systems.
This role involves engineering activities within an active GMP manufacturing site, requiring the ability to manage modifications and improvement projects while maintaining production continuity and regulatory compliance.
Specialized Manufacturing Environment
The position operates within a highly regulated pharmaceutical manufacturing environment involving:
* High-containment production systems
* Multipurpose batch processing facilities
* Solvent-intensive and hazardous chemical operations
* GMP-regulated pharmaceutical manufacturing
* Contamination control and cross-contamination prevention strategies
Key Responsibilities
* Design and development of chemical-pharmaceutical process plants, including layouts, PFDs, P&IDs, and technical specifications
* Oversight of installation, commissioning, qualification activities, and FAT/SAT processes
* Management of external suppliers, contractors, and technical partners during equipment installation or plant modification projects
* Coordination with equipment manufacturers and engineering vendors
* Preparation, maintenance, and updating of technical documentation
* Root cause analysis, deviation investigations, and implementation of CAPA activities
* Support change control processes within regulated manufacturing environments
* Drive process optimization initiatives focused on efficiency, reliability, and cost reduction
* Support equipment qualification and validation activities (IQ/OQ/PQ), including qualification documentation packages
* Plan and coordinate routine and non-routine maintenance activities
* Contribute to expansion projects, technology upgrades, and manufacturing improvement initiatives
* Collaborate cross-functionally with QA, HSE, Regulatory Affairs, Production, and R&D teams to ensure compliance and operational performance
* Provide technical support during internal and external inspections or audits
* Participate in capital investment projects, plant expansions, and technology implementation programs
Candidate Profile
* Degree in Chemical Engineering, Industrial Engineering, or a related discipline
* 3–5 years’ experience within pharmaceutical, API, chemical manufacturing, or other regulated industrial environments
* Knowledge of GMP requirements and regulated manufacturing environments
* Experience with plant design documentation including PFDs, P&IDs, and technical layouts
* Strong English communication skills
* Analytical mindset with strong problem-solving capabilities
* Ability to identify and implement technical improvements that enhance reliability, safety, and operational efficiency
Preferred Experience
* Exposure to high-potency compounds, complex APIs, or hazardous chemical manufacturing environments
* Experience working with batch processing and multi-step chemical synthesis operations
* Understanding of HVAC systems and controlled manufacturing environments
* Familiarity with regulatory inspections from international health authorities
* Experience using CAD software (e.g., AutoCAD) and advanced Excel functions
* Knowledge of containment technologies and safety systems for potent substances
* Experience with one or more of the following:
* Clean utilities
* Classified HVAC environments
* Inert gas systems
* Solvent recovery systems
* ATEX environments
* Process safety systems
Soft Skills
* High attention to detail and accuracy
* Strong organisational and prioritisation abilities
* Effective communicator with the ability to work across multidisciplinary teams
* Proactive, solutions-focused mindset
* Comfortable operating within fast-paced and technically complex environments
* Hands-on engineering approach within industrial settings
* Pragmatic problem solver with strong operational awareness
* Ability to balance compliance requirements, timelines, and business needs