Gertek is a leading technical services provider dedicated to delivering high-quality engineering, compliance, and project management solutions to the life sciences and pharmaceutical industries. We pride ourselves on our technical expertise and our ability to partner with global clients to bring life-saving products to market safely and efficiently. As we continue to expand our operations, we are seeking a dedicated API Project Engineer to join our professional team.
Role Overview
The API Project Engineer will play a critical role in the design, procurement, and execution of Active Pharmaceutical Ingredient (API) manufacturing processes. You will be responsible for ensuring that both new and existing products are integrated into the facility with a focus on technical excellence, safety, and regulatory compliance.
Key Responsibilities
Process Design: Develop PFDs (Process Flow Diagrams) and P&IDs (Piping and Instrumentation Diagrams) for new and existing products being transferred into the facility.
Optimization: Focus on design development to maximize project yields while proactively eliminating contamination risks.
Procurement Management: Develop and manage comprehensive procurement packages for essential unit operations, including:
Reactors and head tanks.
Solvent storage and crystallizers.
Drying and powder handling systems.
Regulatory Compliance: Complete all process designs in strict accordance with GMP practices to meet global FDA standards.
Safety & Risk Management: Support Process Hazard Analysis (PHA) and Hazops of process designs to manage thermal risks and hazardous material handling.
Project Coordination: Collaborate with the wider project team to develop and maintain schedules for design, construction, and C&Q (Commissioning and Qualification) to ensure overall project objectives are met.
Requirements
Proven experience as a Project or Process Engineer within an API or pharmaceutical manufacturing environment.
Strong technical proficiency in developing process documentation (PFDs/P&IDs).
In-depth understanding of GMP environments and global FDA regulatory requirements.
Experience participating in PHA and Hazops.
Ability to manage complex procurement packages for specialized pharmaceutical equipment.
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