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Job Description
Overview
Ensure the efficient operation and compliance of Apex Pharma’s water treatment systems to provide a continuous supply of high-purity water for pharmaceutical manufacturing. This role maintains and monitors all water purification processes (RO, EDI, Purified Water, WFI) so that water is free of contaminants and meets stringent purity standards, thereby supporting product safety and meeting regulatory requirements. Regulatory bodies mandate that water used in production meets the specifications for Purified Water (PW) and Water for Injection (WFI), and failing to do so can result in fines, production delays, or product recalls.
Key Accountabilities:
- Operation of Water Systems: Run and oversee daily operation of RO, EDI, PW, and WFI systems, ensuring continuous compliance with standards.
- Monitoring & Quality Control: Track water quality parameters (pH, conductivity, TOC, endotoxin, microbes) and report deviations.
- System Maintenance & Sanitization: Execute preventive/corrective maintenance and perform system sanitization as scheduled.
- Troubleshooting: Detect and resolve equipment malfunctions or deviations to maintain uninterrupted supply.
- Documentation & Compliance: Record operations, maintenance, and quality data in logbooks and SOPs per GMP standards.
- Quality Testing & Collaboration: Coordinate with QA/QC on sampling, testing, and release of water systems.
- Chemical Handling & Inventory: Safely manage treatment chemicals and maintain required inventory levels.
- GMP Compliance & Audits: Ensure compliance with cGMP/ISO, support internal and external audits.
- Training & Supervision: Guide and supervise utilities technicians in water system operations and safety.
Job Requirements
- Education: Bachelor’s degree in Chemistry, Chemical Engineering, Industrial Engineering, or a related field.
- Experience: +10 Years of Proven experience in operating and maintaining water treatment systems. Experience in a pharmaceutical manufacturing environment or other cGMP-regulated industry is strongly preferred. Candidates with an engineering background should have direct water systems experience, and those with a chemistry background should have practical experience with water purification processes.
- Must have experience in dealing with Stilmas water treatment machines.
- Expertise: Hands-on knowledge of water purification technologies such as reverse osmosis, deionization or EDI, ultrafiltration, and distillation for WFI.
- Regulatory Knowledge: Understanding of pharmaceutical water quality requirements and standards (e.g. USP specifications for Purified Water and Water for Injection, as well as EMA/FDA guidelines). Knowledge of validation and qualification protocols for utility systems is an advantage.