Senior Validation/Equipment Qualification Specialist
12 hours ago
Esco Aster PTE. LTD. is a leading Contract Research Development and Manufacturing Organization (CRDMO) in the life sciences industry. Our company has a strong presence in Singapore, with annual revenues close to SGD 200M and operations in over 42 locations globally.
About the Job
We are seeking an experienced Senior Validation/Equipment Qualification Specialist to join our team. This is a fantastic opportunity for a skilled professional to own their career and contribute to the success of our organization.
Job Description:
The Senior Validation/Equipment Qualification Specialist will be responsible for ensuring that all commissioning qualification and validation activities are planned and executed efficiently and compliantly. The successful candidate will work closely with the leadership team to develop a continuous improvement mindset and engage in teamwork with cross-functional departments.
Key responsibilities include:
• Performing risk-based commissioning, qualification, and validation of pharmaceutical and biopharmaceutical equipment, utilities, facilities, and processes
• Developing validation protocols and reports that meet regulatory requirements and industry best practices
• Assisting in developing User Requirements Specification documents
• Preparing design review and design qualification documents at the initial design stage to align with specifications
• Generating protocols and executing field work related to Commissioning (FAT, SAT), Installation & Operational Qualification (IOQ)
• Preparing and executing validation activities pertaining to Performance Qualification (PQ), Computerized System Validation (CSV), Cleaning Validation, Thermal Validation, and Transport Qualification as required
• Completing assigned CQV tasks according to planned schedule, budget, safety, and engineering standards
• Coordinating with internal teams (manufacturing, engineering, quality etc.) to achieve CQV objectives
• Coordinating and managing external parties, primarily vendors and contractors to achieve CQV objectives
• Investigating deviations and writing deviation reports and findings
• Undertaking tasks assigned by leaders as and when appropriate
Requirements:
To be successful in this role, you will need:
• A degree and/or diploma in Engineering/Science or related studies
• Minimum of 3-5 years' experience in pharmaceutical/biopharmaceutical manufacturing facility
• Familiarity with working in a GxP environment and keeping up to date with current GxP, with flexibility to change as needed due to new regulatory requirements and technologies, as relevant for clinical and commercial supply
• Good knowledge of GxP, GDP, CQV approaches including Validation Lifecycle approach (URS, DQ, FAT/SAT, IOQ, CSV, Cleaning/Thermal Validation etc.), regulatory requirements, and best industry practices
• Competent in technical writing and presentations
• Proficient in MS Office Suite (Microsoft Word, PowerPoint, Excel)
• Able to work independently, self-starter, self-motivated, and task-oriented
• Good communication skills and able to openly communicate and escalate any relevant issues
• Strong team player to work with both internal and external stakeholders
• Develop positive relationships with a strong set of interpersonal skills
Salary Range: SGD $80,000 - SGD $120,000 per annum, depending on experience.
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