Lowongan Senior Validation/Validation Engineer di PT Esco Bintan Indonesia

Esco Lifesciences Group provides enabling technologies, products and services to the life sciences and healthcare industries, supporting academic research and scientific discoveries, clinical practice, as well as biopharmaceutical R&D and manufacturing. Headquartered in Singapore, Esco has an extensive sales network in over 100 countries, direct sales and service offices in 24 countries, 8 manufacturing and R&D hubs in the US, Europe, the UK, China, Singapore, Indonesia, and over 1500 employees worldwide.

The scope:

You will be part of Esco Aster's MSAT team and contribute to the overall site mission and objectives. You will ensure Commissioning Qualification and Validation (CQV) activities and tasks are planned and executed in an efficient and compliant manner, while adhering to GxP standards. You will work with the Leadership team of MSAT to develop a continuous improvement mindset and engage in teamwork with cross-functional departments.

Job Descriptions:

• Perform risk-based commissioning, qualification and validation of pharmaceutical and biopharmaceutical equipment, utilities, facilities, and processes.
• Develop validation protocols and reports that fulfil regulatory requirements and industry best practices. 
• Assist in developing User Requirements Specification documents.
• Prepare design review and design qualification documents at the initial design stage to align with specifications.
• Generate protocols and execute field work related to Commissioning (FAT, SAT), Installation & Operational Qualification (IOQ). 
• Prepare and execute validation activities pertaining to Performance Qualification (PQ), Computerized System Validation (CSV), Cleaning Validation, Thermal Validation and Transport Qualification, as required.
• Complete assigned CQV tasks according to planned schedule, budget, safety, and engineering standards.
• Coordinate with internal teams (manufacturing, engineering, quality etc.) to achieve CQV objectives. 
• Coordinate and manage external parties, primarily vendors and contractors to achieve CQV objectives. 
• Investigate deviations and write deviation reports and findings.
• Undertake tasks assigned by leaders as and when appropriate.

Requirements:

• Degree and/or Diploma in Engineering/Science or related studies. 
• Minimum of 10 years’ experience in pharmaceutical/biopharmaceutical manufacturing facility.
• Familiar 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 relationship with a strong set of interpersonal skills. 
• Willing to travel overseas.