1,589 Validation Specialist jobs in Singapore

Job Responsibilities:
Contribute to Life Science projects for Antaes Asia clients
Manage change control processes for computer systems, ensuring accurate documentation, risk assessment, and approval workflow.
Coordinate with relevant departments to assess the impact of changes and ensure successful integration into existing systems.
Support Corrective and Preventive Actions (CAPA) for computer systems, conducting root cause analysis and implementing effective solutions.
Utilize and manage TrackWise for quality management processes, including deviations, CAPAs, and change control tracking.
Develop and configure TrackWise workflows and ensure proper documentation.
Develop and execute validation test scripts for Kneat to verify functionality, performance, and regulatory compliance.
Document test results, deviations, and corrective actions, and ensure alignment with validation protocols.
Contribute to the promotion of Antaes services on top of assistance provided to clients.
Job Requirements:
Bachelor’s degree in Computer Science, Life Science, or a related field
1-2 years of experience in validation of computer systems in the pharmaceutical industry
Proficiency in Kneat, TrackWise, CAPA, and change control processes.
Familiarity with industry regulations (e.g., FDA 21 CFR Part 11, GAMP 5).
Ensure compliance with 21 CFR Part 11 and other relevant data integrity regulations.
Strong documentation and technical writing skills.
Candidate must be highly motivated, able to work independently as well as in a team, and possess good organizational and oral and written communication skills.
Excellent communication skills, both written and verbal, in English.
Platform and Cloud Hosting Team Responsibilities:
Deploy, support, and maintain global Private Cloud infrastructure (compute, storage, software defined network, etc.)
Advise internal partners on how to leverage the Cloud – Private or Public – to increase the delivery of business value.
Guide and assist our application team to adopt our cloud-native technologies.
Work closely with regional and global teams to support on the platform.
Additional Responsibilities:
Install, configure, and support cloud platform underlying resource plane and control plane infrastructure (hardware and software components).
Release projects and maintenance operations in production without impact.
Be a technical reference for internal partners and advise on standard Cloud practices or innovative solutions to bring value to a competitive and challenging market environment.
Structure and guide our internal partners through their Cloud-Journey, accelerate the adoption of Cloud technologies and best practices, and provide consolidated reporting across the organization.
Create technical content such as reference apps, starter kits, and patterns and practical guidance that will get our developers excited about the potential of the Cloud.
Represent the team in various regional and global forums where technical expertise is required.
Be a technical reference and mentor for the team to increase their knowledge about software development & cloud patterns.
Coordinate activities and processes required for effective day-to-day organization of IT Infrastructure assets and contracts management.
Manage resource onboarding/offboarding/contract extension and headcount tracking and reporting including PPM Management and reporting.
Asset Management Responsibilities:
Develop and maintain frameworks, RACI, and end-to-end process/engagement model for onboarding IT Assets in the region (reconciling with financial books).
Assist with the governance of asset inventory including stock take and checks.
Conduct periodic internal quality assurance assessments across the IT Asset portfolio, highlighting any potential gaps, defining a remediation plan, and ensuring continued adherence to Group IT Asset Management standards.
Contract Management Responsibilities:
Ensure all contracts are registered in SourcingHub and aligned to Marley Asset Inventory.
Ensure adherence to contracts and sourcing requirements of existing vendor services.
Escalate appropriately to ensure Department Accountable Ex-Co are informed and necessary remediation implemented.
Assist with designing processes to streamline and maintain an accurate BAU contracts management schedule.
Business Management / PMO Responsibilities:
Publish reports of CTB/RTB consumption from Pyramid and follow-ups.
Assist with producing TCO reporting (on Apptio).
Work with Procurement and Expense team on follow-ups and maintain governance.
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We are seeking a skilled professional to provide expertise in performing Computerized Systems Validation. This includes qualification of Computerized Systems, including Automation Systems (PCS 7, EMS, MES) and GMP equipment qualifications operating within the framework of regulations GxP, 21CFR11, etc.

• Provide primary personnel for qualification of Computerized Systems.
• Collaborate with Compliance Engineering team on CQV activities.
• Coordinate with internal and external teams to achieve site objectives.
• Prepare, review, and approve SOPs and qualification-related documentations.
• Ensure qualification strategy is sound and adhere to company standards and regulatory requirements.
• Investigate deviations and write deviation reports and findings.
• Raise and follow-up change control records.

• Degree in Engineering/Science or related studies.
• Minimum 3 years experience in relevant industry with at least 3 years in CSV, Quality Assurance, CQV, and Turnover Activities.
• High level of understanding in Regulatory compliance.
• 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.
• In-depth knowledge in Computer System Validation (CSV), GAMP 5, 21 CFR Part 11, ER/ES, validation lifecycle, current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
• 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.
• Develop Computer Validation Strategy, plans, protocols, reports, risk assessment, requirement traceability matrix etc for any new or change induced validation system / activities.

As a key member of our team, you will be responsible for ensuring that all computerized systems meet the highest standards of quality and reliability. You will work closely with our compliance engineering team to develop and implement effective qualification strategies, and collaborate with internal and external stakeholders to ensure successful project outcomes.

If you have a strong background in computer system validation and a passion for delivering high-quality results, we encourage you to apply for this exciting opportunity.

• Responsible for contributing to the development and implementation of software validation strategies and procedures.

As a Software Validation Engineer, you will be responsible for:

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To be successful in this role, you will need:

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This role offers a competitive salary and benefits package, including:

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We are seeking a skilled professional to ensure compliance with 21 CFR Part 11 Annex 11 Alcova principles and data integrity requirements in our laboratory environment.

• Develop and execute qualification/validation plans for analytical instruments, such as HPLC, GC, UV, CDs, LIMS, and Empower.
• Prepare, review, and execute CSV deliverables, including URS, IQOQ, PQ, RTM, and summary reports.
• Perform data integrity assessments and ensure compliance with Alcova GDP/GMP guidelines.
• Contribute to the development and maintenance of validation-related SOPs for QC systems and equipment.
• Support audits and inspections with accurate validation documentation.
• Collaborate with QC, QA, and IT teams to ensure readiness for system lifecycle activities, periodic review, change control, upgrades, and cyber resilience.
• Participate in continuous improvement initiatives to strengthen laboratory compliance.

• Bachelor's degree or higher in chemistry, life sciences, engineering, or a related field.
• 5-10 years' experience in CSV/validation of analytical instruments within QC labs in pharmaceutical/biotech environments.
• Strong knowledge of CGaMP, GAMP 5, 21 CFR Part 11 Annex 11, and data integrity frameworks.
• Experience with microbiology analytical equipment is an advantage.
• Hands-on use of Kneat or other e-validation platforms preferred.
• Strong technical documentation and troubleshooting skills.
• Able to work cross-functionally and support audit readiness.

Responsibilities:

• Validation quality review of lifecyle documents and protocols for Automation CSV qualification, EFU qualification, cleaning validation, laboratory equipment qualification, and IT systems qualification.
• Review and approve validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines timely
• Review and approve as needed, qualification/validation executed package validation exceptions, deviation, and investigations encountered during qualification/validation representing Quality
• Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification/validation activities
• Participate in site Validation Maintenance Program
• Any other tasks as and when assigned by supervisor
• Support other technical changes and duties as require

About You:

• Diploma/Bachelor/Master/Doctoral Degree in Engineering/Science
• At least 5 years qualification/validation experience
• Possess process automation experience will be the additional benefit to be considered
• Communicate well, self driven, motivated and able to work well with others
• Based in Tuas

Job Type: Contract

Contract length: 9 months

• Document Management
• Analytical Skills
• Interpersonal Skills
• Microbiology
• Computer System Validation
• Project Management
• Windows
• Team Player
• Audit

We are looking for a talented professional to fill the role of Analytical Validation Specialist .

This position is ideal for individuals with strong experience in Computer System Validation (CSV) and a passion for ensuring compliance with global validation standards in regulated environments.

The successful candidate will be responsible for leading CSV activities for analytical equipment or instruments and lab computerized systems. This includes developing and executing validation deliverables such as URS, risk assessments, IQ/OQ/PQ, RTM, and summary reports.

The key responsibilities of this role include:

• Ensuring compliance with 21 CFR Part 11, Annex 11, ALCOA+ principles, and data integrity controls.
• Evaluating and validating audit trails, security settings, and user access controls.
• Supporting integration between instrument, PC, network, and enterprise systems.
• Drafting, reviewing, and maintaining SOPs, validation documentation, and audit readiness materials.
• Contributing to lifecycle management of systems including periodic reviews, upgrades, and change control.

To succeed in this role, you will need:

• A Bachelor's degree in chemistry, Life Sciences, Engineering, or a related discipline.
• 3-10 years' experience in analytical instrument/equipment CSV within pharmaceutical/biotech QC labs.
• Strong knowledge of cGMP, GAMP 5, 21 CFR Part 11, Annex 11.
• Familiarity with electronic validation tools is preferred.

Job Title: Data Validation Specialist

About the Role:
We are seeking a skilled Data Validation Specialist to join our team. As a key member of our quality assurance department, you will play a vital role in ensuring that our computerized systems meet the required standards for quality and regulatory compliance.

Key Responsibilities:
As a Data Validation Specialist, your primary responsibilities will include:

• Developing and implementing a risk-based validation strategy to ensure that all computerized systems meet the required standards for quality and regulatory compliance.
• Collaborating with cross-functional teams to define and implement validation plans, protocols, and reports.
• Providing quality oversight for establishing and maintaining site's computerized systems validation program in accordance with current regulatory expectations, industry practices, and company standards.
• Functioning as a key quality reviewer and approver of CSV lifecycle documents.

Requirements:
To be successful in this role, you will need:

• A strong understanding of computerized systems validation (CSV) principles and practices.
• Excellent communication and collaboration skills.
• Ability to work effectively in a fast-paced environment.
• Strong analytical and problem-solving skills.

What We Offer:
We offer a competitive compensation package, opportunities for career growth and development, and a dynamic work environment.

We are seeking a highly skilled Product Testing Engineer to join our team.

Job Description:

The successful candidate will be responsible for establishing standard flow / operating instructions / test specification for Test Engineering and CP Manufacturing process.

Key Responsibilities:

• To establish standard flow / operating instructions / test specification for Test Engineering and CP Manufacturing process.
• Work and communicate with customers on New Product Introduction (NPI) and Coordinate device start up.

Requirements:

Our ideal candidate will have experience in product testing, excellent communication skills, and the ability to work well under pressure.

What We Offer:

Our company offers a competitive salary, comprehensive benefits package, and opportunities for career growth and development.

How to Apply:

If you are a motivated and experienced Product Testing Engineer looking for a new challenge, please submit your application.