Validation Engineer (Pharmaceutical, Qualification)

Responsibilities:

• Perform risk-based commissioning, qualification and validation service for pharmaceutical and biopharmaceutical clients on one or more of the following areas:

1. Process Equipment
2. CIP / SIP
3. Process Manufacturing and related business processes including Quality Operations and Supply Chain Operations
4. Method validation (analytical chemistry, biochemistry, microbiological)
5. Enterprise system (LIMS, QMS)

• Develop risk assessment, system impact assessments, protocols and reports that support the qualification and validation requirements in the industry.
• Develop validation protocols using a science and risk -based approach that meets regulatory requirements and industry best practices.
• Review, analyse, interpret, and summarize system and process performance data of executed activities for report and presentation to management.
• Investigate deviations, write investigation reports and create summary reports.
• Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

Professional Skills and Experience:

• Bachelor’s degree in technical discipline such as Engineering, Pharmaceutical Science or with experience relevant.
• Minimum 2 - 3 or more years of experience in several functions in pharmaceutical industry: commissioning, qualification, validation, quality systems, quality operations, manufacturing, engineering, technology transfer.
• Foundational understanding of ICH Q7, Q8, ICH Q9, ISO 14644, ANSI Z1.4 and other regulatory requirements preferred
• Experience with investigations into manufacturing / laboratory deviations and determination of product impact potential, root cause and corrective/preventive actions.
• Knowledge of Validation Lifecycle approach (URS, FAT/SAT, commissioning, I/O/PQ Protocols, etc), guidelines, international regulatory requirements and other industry best practices.
• Preferred to have experiences in multiple CQV discipline (such as CIP, SIP, process, utility, equipment, automation, computer system, lab system), preferably with advanced technical knowledge in one or more discipline.
• Preferred to have experience interacting with or creating material for management and regulatory agencies.

Interested candidates please apply online or send your latest CV to [email protected]

AlwaysHired Pte Ltd

Reg No: R1549345

EA: 24C2293