Current jobs related to Commissioning, Qualification, and Validation - Ayer Rajah Crescent - Esco Aster Pte Ltd
-
Senior Validation/validation Engineer
7 days ago
Ayer Rajah Crescent, Singapore Esco Aster Pte Ltd Full time**The Opportunity** 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...
-
Bioinformatics Scientist/engineer
2 weeks ago
Ayer Rajah Crescent, Singapore Natural Trace Pte Ltd Full time**Role Overview** We are seeking a highly driven **Bioinformatics Scientist / Engineer** to join our team. This role bridges applied bioinformatics, molecular genomics, and molecular diagnostics, with real-world impact on food safety and consumer trust. **Key Responsibilities** - Analyse microbial genomes, identify clusters/patterns and unique DNA...
-
Quality Control
7 days ago
Ayer Rajah Crescent, Singapore Esco Aster Pte Ltd Full time**The Opportunity** Esco Lifesciences Group, is Singapore’s most globalized life sciences company, with annual revenues close to SGD 200M and global operations in over 20 countries across North America, Europe and Asia. Esco Aster Pte Ltd is an affiliate of Esco Lifesciences Group and was first introduced in 2017. At Esco Aster Pte Ltd, we are a...
-
Cmms Admin and Scheduler
3 hours ago
Ayer Rajah Crescent, Singapore Esco Aster Pte Ltd Full time**The Opportunity** Esco Lifesciences Group, is Singapore’s most globalized life sciences company, with annual revenues close to SGD 200M and global operations in over 20 countries across North America, Europe and Asia. Esco Aster Pte Ltd is an affiliate of Esco Lifesciences Group and was first introduced in 2017. At Esco Aster Pte Ltd, we are a...
-
Data Analyst
2 weeks ago
Ayer Raja New Town, Singapore ONCOSHOT PTE. LTD. Full time $4,000 - $6,000 per yearJob Scope To support the IT team with the identification, masking, and labelling of Personally Identifiable Information (PII) within datasets used to train or interact with Large Language Models (LLMs). This role ensures compliance with data protection regulations (e.g., PDPA, GDPR) while maintaining dataset utility and model performance. Key...
-
Quality Control
2 weeks ago
Ayer Raja New Town, Singapore Esco Aster Full time $60,000 - $80,000 per year**The Opportunity** Esco Lifesciences Group, is Singapore's most globalized life sciences company, with annual revenues close to SGD 200M and global operations in over 20 countries across North America, Europe and Asia. Esco Aster Pte Ltd is an affiliate of Esco Lifesciences Group and was first introduced in 2017. At Esco Aster Pte Ltd, we are a contract...
-
Cell Therapy Biotechnologist
2 weeks ago
Ayer Raja New Town, Singapore Esco Aster Full time $90,000 - $120,000 per yearJoin us for the world we are making, redefining biosolutions for current and future generations to come, transcending planetary boundaries, sustainability, and One Health.Growth We empower each other to produce better results by providing professional advancement and personal growth. We are driven by the challenge of creating something new and discovering...
Commissioning, Qualification, and Validation
3 weeks ago
**The Opportunity**
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 over 20 countries, 8 manufacturing and R&D hubs in the US, Europe, the UK, China, Singapore, Indonesia, and over 1300 employees worldwide
Esco is poised to benefit from the sustained growth of the healthcare and biopharma industries in Asia and globally. Esco has achieved market leadership in China, and globally, in multiple categories within some of the fastest-growing segments — with China being its largest and fastest growing market. As a Singapore-headquartered company, Esco is a nexus of East and West, bridging technologies, products and talent across the world, with global operations spanning the US, Europe and Asia.
**The Scope**
Primary work location: Ayer Rajah Crescent, Singapore
The CQV Manager will report to the CEO.
**Responsibilities**:
- Overall accountability for company validation program including: commissioning & qualification, computerized system validation, thermal validation, decontamination & sterilization validation, process validation, cleaning validation, transport qualification, aseptic process simulation and validation maintenance activities.
- Performs strategic planning and development of activities for company CQV function, including compliance, capacity, timelines and directions. Collaborates closely with senior leadership team in meeting corporate and organizational goals through establishing and reporting of department or organizational metrics.
- Establish, generate, and maintain CQV department procedures in compliance with company and industry standards.
- Owns and maintain the validation program quality systems.
- Develops Validation Plans for validation projects and oversee contract staff, when necessary, through development of statement of work and vendor selection.
- Write, review and approve associated commissioning, qualification and validation protocols and reports including executed protocols. Ensures appropriate resolution of protocol exceptions.
- Generate, review and approve CQV associated deviations, CAPAs. Perform/ lead investigations and RCAs as required.
- Perform CQV associated change control assessments.
- Primary point of contact for CQV associated audit requests. Present and defend validation studies during regulatory, partner and internal inspections.
- Authors or reviews validation section of annual periodic product reviews.
- Lead or participate in risk assessments and gap analysis.
- Lead continuous improvement initiatives.
- Develop work plans, assign tasks, and lead team(s).
**Authority**
- Authority for the CQV program and associated cGMP implementation and improvements.
- Authority to approve changes made to the CQV program.
**Requirements**:
- Degree in Biotechnology/ Chemical Engineering/ Bioengineering/ Life Sciences or related studies.
- Minimum of 8 years in an engineering or quality role in a cGMP related role with at least 2 years in a people management role.
- Highly adaptable and capable of performing in a dynamic working environment.
- Knowledgeable on cGMP manufacturing of investigational products and their associated requirements. Able to ensure validation activities for the manufacturing of products in preclinical and clinical trials (Phase 1, 2, 3) are performed in a manner appropriate to the current stage of the product lifecycle.
- Good grasp of aseptic processing knowledge pertaining to cGMP manufacturing of Cell & Gene Therapy associated products.
- Strong understanding of regulations related to manufacturing of Cell & Gene Therapy products. Good ability to define validation deliverables suited for each product to fulfil regulatory requirements.
- Knowledge of Validation Lifecycle Approach.
- Familiarity and Understanding of Validation using risk-based approaches.
- Experience in facility design, qualification and start up.
- Ability to read/interpret engineering drawings and design documents.
- Good understanding of computerized system validation and data integrity principles.
- Strong technical writing abilities in being able to write from ground up SOPs and able to review as relevant to relevant ISPE/PDA, cGMP Guidelines and technical working documents.
- Self-starter, self-motivated and task oriented. Able to motivate team to ensure deliverables are completed in a timely fashion.
- Builds relationship and connects with colleagues in a way that creates a sense of team purpose and achievement.
**Preferred Experience(s)**
- Strong interpersonal, organization and technical skills. Capability to work both independently and in a team environment with ability to provide guidance.
- User experience with software tools on CMMS, QM
