Senior Validation/Equipment Qualification Specialist

12 hours ago


Singapore ESCO ASTER PTE. LTD. Full time
About Esco Aster PTE. LTD.

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.

  • Singapore NUSANTARA PRIME CONSULTING PTE. LTD. Full time

    About the Role:">We are seeking a highly skilled Senior Laboratory Equipment Qualification Specialist to join our team at NUSANTARA PRIME CONSULTING PTE. LTD.This is an exciting opportunity for a professional with expertise in laboratory equipment qualification, validation, and compliance to work on various projects across different industries.The successful...


  • Singapore ANTER CONSULTING PTE. LTD. Full time

    About ANTHER CONSULTING PTE. LTD.We are seeking a highly skilled and experienced Senior Validation Specialist to join our team in Singapore. The successful candidate will be responsible for leading the commissioning, qualification, and validation (CQV) activities for pharmaceutical manufacturing facilities, equipment, and systems.Salary RangeThe estimated...


  • Singapore PROCESS ENGINEERING SPECIALISTS PTE. LTD. Full time

    We are seeking an experienced Senior Validation Specialist to join our team at Process Engineering Specialists PTE. LTD. in a permanent role. As a key member of our team, you will be responsible for leading the commissioning and validation of pharmaceutical process equipment.The ideal candidate will have a strong background in process automation and...


  • Singapore PHARMAGEND GLOBAL MEDICAL SERVICES PTE. LTD. Full time

    Job SummaryWe are seeking an experienced Senior Validation Specialist to join our team at PHARMAGEND GLOBAL MEDICAL SERVICES PTE. LTD.About the RoleThe ideal candidate will have a strong background in validation and quality assurance, with a minimum of 5-7 years' experience in pharmaceutical manufacturing environments.Key ResponsibilitiesDevelop and...


  • Singapore PROCESS ENGINEERING SPECIALISTS PTE. LTD. Full time

    We are seeking a Senior Validation Specialist to join our team at Process Engineering Specialists PTE. LTD.The ideal candidate will have extensive experience in validating biopharmaceutical GMP plants, including facilities, utilities, and equipment, control systems, processes, and computerized systems.Responsibilities:Review and approve C&Q plans, protocols,...


  • Singapore COALESCE MANAGEMENT CONSULTING PTE. LIMITED Full time

    About Coalesce Management ConsultingWe are a community of high-calibre industry specialists delivering bespoke project solutions in the Life Science and Technology sectors.Job Overview:A Senior Validation Specialist is required to support projects with independent, effective and timely testing services, ensuring tasks are performed according to requirements,...


  • Singapore RECRUIT EXPRESS PTE LTD Full time

    Job DescriptionWe are seeking a highly skilled Senior Validation Specialist to join our team at RECRUIT EXPRESS PTE LTD.About the JobThis is a 6-month contract position with an estimated salary of $4500 - 8000 (Depending on experience).Key Responsibilities:Support site projects on Qualification/Validation, Assessment and Approval of Documents.Review and...


  • Singapore PROCESS ENGINEERING SPECIALISTS PTE. LTD. Full time

    Job DescriptionWe are currently looking for Process Equipment Engineers to join our team at PROCESS ENGINEERING SPECIALISTS PTE. LTD.About the RoleThis is a fantastic opportunity to work with our experienced team in providing high-quality services to our clients in the Life Sciences Industry.As a Process Equipment Engineer, you will be responsible for...


  • Singapore PHARMAGEND GLOBAL MEDICAL SERVICES PTE. LTD. Full time

    We are seeking a highly skilled Validation and Qualification Expert to join our team at PHARMAGEND GLOBAL MEDICAL SERVICES PTE. LTD.About the RoleThis is an exciting opportunity for a qualified professional with a strong background in validation and qualification principles to contribute to our company's mission of delivering high-quality services in the...


  • Singapore Amaris Consulting Full time

    Job Title: Senior System Validation SpecialistAmaris Consulting is a leading provider of consulting services in the pharmaceutical and biotech industries.Estimated Salary: $120,000 - $180,000 per yearAbout the Role:We are seeking an experienced Senior System Validation Specialist to join our team. The ideal candidate will have a strong background in system...


  • Singapore ESCO ASTER PTE. LTD. Full time

    Esco Aster Pte. Ltd., a globalized life sciences company, is seeking a skilled Senior Validation/Validation Engineer to join its MSAT team in Singapore.The Opportunity:We are a contract research development and manufacturing organization that enables fellow scientists to translate their bench work into commercially available products at affordable prices.Our...


  • Singapore International Bearings Pte Ltd Full time

    Process Engineering Specialists is an international services company providing Project Management, Construction Management, Commissioning & Qualification, and Automation services to our clients in the pharmaceutical, nutritional, and related sectors. With offices across Europe, Asia, and the US, our core focus is on consistently delivering high-quality...


  • Singapore PSC BIOTECH PTE. LTD. Full time

    Job OverviewPSC BIOTECH PTE. LTD. is seeking a highly skilled and experienced Senior Validation Specialist to join our team in ensuring the highest standards of quality and compliance in our biotech/pharmaceutical environment.SalaryThe estimated salary for this position ranges from SGD $80,000 to SGD $120,000 per annum, depending on qualifications and...


  • Singapore NUSANTARA PRIME CONSULTING PTE. LTD. Full time

    NUSANTARA PRIME CONSULTING PTE. LTD. We are seeking a skilled Validation Specialist to join our team for a 9-month contract. The successful candidate will have experience in pharmaceutical equipment qualification, specifically with HVAC and utilities validation (IQ/OQ/PQ/CPV).About the Role:Candidate must possess a diploma or degree in engineering or science...


  • Singapore HUP HIN HEAVY EQUIPMENT PTE. LTD. Full time

    We are seeking a highly skilled and experienced Heavy Equipment Crane Maintenance Specialist to join our team at HUP HIN HEAVY EQUIPMENT PTE. LTD.Job DescriptionThe successful candidate will be responsible for ensuring the proper maintenance of assigned cranes, including regular lubrication, cleaning, and daily safety checks. This role requires a high level...


  • Singapore NUSANTARA PRIME CONSULTING PTE. LTD. Full time

    Job SummaryWe are seeking a highly skilled Quality Validation Specialist to join our team at NUSANTARA PRIME CONSULTING PTE. LTD. in Tuas. As a key member of our validation team, you will be responsible for ensuring the quality and accuracy of lifecycle documents and protocols.About YouYou hold a Diploma/Bachelor/Master/Doctoral Degree in Engineering/Science...


  • Singapore PHARMENG TECHNOLOGY PTE. LTD. Full time

    Roles & ResponsibilitiesResponsibilities: Provide direct services to site Technical Services management, contributing to increased throughput of commissioning and qualification activities across the site. Collaborate with Technical Services management while independently performing required validation activities. Support C&Q activities across the site as...


  • Singapore Snaphunt Full time

    About the RoleAs a Senior Validation Specialist, you will be responsible for leading the cleaning validation process at our client's Biotech Consultancy firm. With a strong background in industrial, healthcare & lifesciences and retail experience, you will ensure the safety and purity of products.Your Key ResponsibilitiesClean validation expert with a focus...


  • Singapore NES GLOBAL PTE. LTD. Full time

    Role OverviewNES Global PTE. LTD. is seeking a Manufacturing Validation Specialist to join their team in Singapore.Job SummaryThis is an exciting opportunity for a highly skilled and motivated individual to work on validating equipment and ensuring compliance with safety and quality standards in the pharmaceutical industry.Responsibilities:Develop,...


  • Singapore ANTER CONSULTING PTE. LTD. Full time

    Roles & ResponsibilitiesWe are seeking a Quality Validation Specialist to perform quality reviews of validation documents and protocols across various areas, including DeltaV automation systems, EFU qualifications, Automation CSV, IT systems, cleaning validation, and laboratory equipment. Key responsibilities include ensuring compliance with regulatory...