829 Validation Specialist jobs in Singapore
Validation Specialist
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Job Description
Job Summary:
- To ensure computerized systems used in manufacturing and quality control processes are validated in compliance with regulatory requirements.
- Provide quality oversight to the validation lifecycle of computerized systems, including environmental monitoring systems, laboratory information management systems, batch record management systems, and digital infrastructure.
- Support the establishment and maintenance of site's computerized systems validation program.
Key Accountabilities
- Ensure all Computerized Systems Validation (CSV) lifecycle activities meet quality requirements and regulatory expectations.
- Collaborate with cross-functional teams to define and implement a risk-based validation strategy.
- Lead quality oversight for establishing and maintaining site's CSV program.
The successful candidate will have strong knowledge of computerized systems validation principles, excellent communication skills, and the ability to work effectively in a team environment.
Senior QA Validation Specialist
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About the Company
The QA Validation Engineer will play a vital role in establishing and maintaining high-quality standards at a growing pharmaceutical manufacturing startup. This position ensures that all manufacturing processes, systems and equipment comply with regulatory standards and quality specification. The incumbent will support continuous improvement initiatives and collaborate with cross-functional teams to build robust quality systems for a successful, compliant manufacturing operation. We are a distinguished brand with more than sixty years of expertise in the pharmaceutical industry. We aim to broaden our presence by using Singapore as a central hub for expansion into other countries.
Responsibilities
- Develop and execute validation protocols for facilities, equipment, utilities, materials, manufacturing process, cleaning and computerized systems.
- Document validation activities and results and maintain records for all validation activities.
- Analyse validation test data to determine whether systems or processes have met validation criteria.
- Author of validation reports.
- Develop and maintain validation master plan.
- Develops re-qualification or re-validation plans to keep the systems in validated states.
- Support audits and inspections as a subject matter expert.
- Provide impact assessment for any planned change to the site and execute any change actions that result from the assessment.
- Work closely with stakeholders to coordinate validation activities.
- Collaborate with cross functional teams to address deviations and implement corrective actions and to prepare periodic product review.
- Train staff on validation procedures and maintain documentations for audits.
- Maintain knowledge of current regulatory intelligence and industry trends.
Qualifications
- Bachelor's degree in Engineering, Pharmacy, Science or a related field.
- Prior work experience as a Validation Engineer or similar role in the pharmaceutical industry or medical device industry.
- Proficient with validation software tools.
- Experience with audit management, regulatory inspections, and handling regulatory queries on validation matters.
- Strong analytical, problem-solving, and organizational skills with a keen attention to detail.
- Strong sense of accountability and ownership of responsibilities.
- Excellent verbal and written communication skills with the ability to present technical concepts to cross-functional teams and senior leadership.
- A commitment to maintaining high standards of quality, safety, and compliance at all times.
Required Skills
- Proficient with validation software tools.
- Strong analytical, problem-solving, and organizational skills.
- Excellent verbal and written communication skills.
Preferred Skills
- Experience with audit management and regulatory inspections.
- Prior work experience in the pharmaceutical or medical device industry.
Pay range and compensation package
Competitive salary and benefits package.
Equal Opportunity Statement
We are committed to diversity and inclusivity in our hiring practices.
Senior QA Validation Specialist
Posted today
Job Viewed
Job Description
About
The QA Validation Engineer will play a vital role in establishing and maintaining high-quality standards at a growing pharmaceutical manufacturing startup. This position ensures that all manufacturing processes, systems and equipment comply with regulatory standards and quality specification. The incumbent will support continuous improvement initiatives and collaborate with cross-functional teams to build robust quality systems for a successful, compliant manufacturing operation.
We are a distinguished brand with more than sixty years of expertise in the pharmaceutical industry. We aim to broaden our presence by using Singapore as a central hub for expansion into other countries.
Responsibilities
- Develop and execute validation protocols for facilities, equipment, utilities, materials, manufacturing process, cleaning and computerized systems.
- Document validation activities and results and maintain records for all validation activities.
- Analyse validation test data to determine whether systems or processes have met validation criteria.
- Author of validation reports
- Develop and maintain validation master plan.
- Develops re-qualification or re-validation plans to keep the systems in validated states.
- Support audits and inspections as a subject matter expert.
- Provide impact assessment for any planned change to the site and execute any change actions that result from the assessment.
- Work closely with stakeholders to coordinate validation activities.
- Collaborate with cross functional teams to address deviations and implement corrective actions and to prepare periodic product review.
- Train staff on validation procedures and maintain documentations for audits.
- Maintain knowledge of current regulatory intelligence and industry trends.
Qualifications:
- Bachelor's degree in Engineering, Pharmacy, Science or a related field.
- Prior work experience as a Validation Engineer or similar role in the pharmaceutical industry or medical device industry.
- Proficient with validation software tools.
- Experience with audit management, regulatory inspections, and handling regulatory queries on validation matters.
- Strong analytical, problem-solving, and organizational skills with a keen attention to detail.
- Strong sense of accountability and ownership of responsibilities.
- Excellent verbal and written communication skills with the ability to present technical concepts to cross-functional teams and senior leadership.
- A commitment to maintaining high standards of quality, safety, and compliance at all times.
What We Offer:
- Competitive salary and benefits package.
- Opportunities for professional development and advancement.
- A dynamic and collaborative work environment.
Senior Treasury Validation Specialist
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Job Description
We are seeking a diligent and detail-oriented Trade Analyst to perform validation of new interest rate derivatives/commodity/options trades against source documents in Murex or Front Arena systems.
The successful candidate will authorise payments and receipts for treasury products, perform fixing procedures in Murex and Front Arena systems, liaise settlement or fixing with counterparties, and monitor end-to-end payment processes.
Chief Laboratory Validation Specialist
Posted today
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Job Description
The primary function of this role is to spearhead commissioning, qualification, and validation activities for laboratory equipment.
About the Role:
- A Bachelor's/Master's degree in Engineering or a Science-related discipline with at least 5 years' experience in lab equipment CSV. Preferably 5 – 10 years' experience in analytical instrument CSV is advantageous.
- Familiarity with microbiology analytical equipment and Kneat system usage is desirable.
- Mastery of regulatory compliance particularly 21 CFR Part 11, audit trails, data integrity controls, Windows, and enterprise systems is essential.
- A strong understanding of the interface between instruments, PCs, networks, and enterprise systems is crucial.
This is a 12-month fixed-term contract position. A potential contract extension may be considered based on performance and business needs.
Your Key Skills- Validation
- Analytical Capability
- Microbiology
- Enterprise Systems
- Computer System Validation
- Equipment Qualification
- Windows
- Audit
- Commissioning
- Lab Equipment
Senior QA Validation Specialist (Pharmaceutical Manufacturing)
Posted today
Job Viewed
Job Description
About
The QA Validation Engineer will play a vital role in establishing and maintaining high-quality standards at a growing pharmaceutical manufacturing startup. This position ensures that all manufacturing processes, systems and equipment comply with regulatory standards and quality specification. The incumbent will support continuous improvement initiatives and collaborate with cross-functional teams to build robust quality systems for a successful, compliant manufacturing operation.
We are a distinguished brand with more than sixty years of expertise in the pharmaceutical industry. We aim to broaden our presence by using Singapore as a central hub for expansion into other countries.
Responsibilities
Develop and execute validation protocols for facilities, equipment, utilities, materials, manufacturing process, cleaning and computerized systems.
Document validation activities and results and maintain records for all validation activities.
Analyse validation test data to determine whether systems or processes have met validation criteria.
Author of validation reports
Develop and maintain validation master plan.
Develops re-qualification or re-validation plans to keep the systems in validated states.
Support audits and inspections as a subject matter expert.
Provide impact assessment for any planned change to the site and execute any change actions that result from the assessment.
Work closely with stakeholders to coordinate validation activities.
Collaborate with cross functional teams to address deviations and implement corrective actions and to prepare periodic product review.
Train staff on validation procedures and maintain documentations for audits.
Maintain knowledge of current regulatory intelligence and industry trends.
Qualifications:
Bachelor’s degree in Engineering, Pharmacy, Science or a related field.
Prior work experience as a Validation Engineer or similar role in the pharmaceutical industry or medical device industry.
Proficient with validation software tools.
Experience with audit management, regulatory inspections, and handling regulatory queries on validation matters.
Strong analytical, problem-solving, and organizational skills with a keen attention to detail.
Strong sense of accountability and ownership of responsibilities.
Excellent verbal and written communication skills with the ability to present technical concepts to cross-functional teams and senior leadership.
A commitment to maintaining high standards of quality, safety, and compliance at all times.
What We Offer:
Competitive salary and benefits package.
Opportunities for professional development and advancement.
A dynamic and collaborative work environment.
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Senior QA Validation Specialist (Pharmaceutical Manufacturing)
Posted today
Job Viewed
Job Description
Overview
The QA Validation Engineer will play a vital role in establishing and maintaining high-quality standards at a growing pharmaceutical manufacturing startup. This position ensures that all manufacturing processes, systems and equipment comply with regulatory standards and quality specification. The incumbent will support continuous improvement initiatives and collaborate with cross-functional teams to build robust quality systems for a successful, compliant manufacturing operation. We are a distinguished brand with more than sixty years of expertise in the pharmaceutical industry. We aim to broaden our presence by using Singapore as a central hub for expansion into other countries.
Responsibilities
Develop and execute validation protocols for facilities, equipment, utilities, materials, manufacturing process, cleaning and computerized systems.
Document validation activities and results and maintain records for all validation activities.
Analyse validation test data to determine whether systems or processes have met validation criteria.
Author validation reports.
Develop and maintain validation master plan.
Develop re-qualification or re-validation plans to keep the systems in validated states.
Support audits and inspections as a subject matter expert.
Provide impact assessment for any planned change to the site and execute any change actions that result from the assessment.
Work closely with stakeholders to coordinate validation activities.
Collaborate with cross functional teams to address deviations and implement corrective actions and to prepare periodic product review.
Train staff on validation procedures and maintain documentation for audits.
Maintain knowledge of current regulatory intelligence and industry trends.
Qualifications
Bachelor’s degree in Engineering, Pharmacy, Science or a related field.
Prior work experience as a Validation Engineer or similar role in the pharmaceutical industry or medical device industry.
Proficient with validation software tools.
Experience with audit management, regulatory inspections, and handling regulatory queries on validation matters.
Strong analytical, problem-solving, and organizational skills with a keen attention to detail.
Strong sense of accountability and ownership of responsibilities.
Excellent verbal and written communication skills with the ability to present technical concepts to cross-functional teams and senior leadership.
A commitment to maintaining high standards of quality, safety, and compliance at all times.
Required Skills
Proficient with validation software tools.
Strong analytical, problem-solving, and organizational skills.
Excellent verbal and written communication skills.
Preferred Skills
Experience with audit management and regulatory inspections.
Prior work experience in the pharmaceutical or medical device industry.
Pay range and compensation package
Competitive salary and benefits package.
Equal Opportunity Statement
We are committed to diversity and inclusivity in our hiring practices.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Pharmaceutical Manufacturing
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Validation Specialist - Advanced Silicon Engineering
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As a semi-conductor system validation engineer, you will play a critical role in ensuring the quality and conformance of our automotive connectivity solutions. Your responsibilities will include developing functional validation plans and test programs for complex high-performance SOC's, owning SOC validation tasks on both emulation and post-silicon platforms, and collaborating with system engineers on SoC architecture optimization.
- You will participate in architectural discussions, providing innovative solutions during the development of the SOC, and work closely with synthesis engineers and back-end engineers on design optimization.
Key aspects of this position include developing validation strategies, implementing test plans, and working closely with cross-functional teams to ensure successful product releases.
Computer Systems Validation (CSV) Specialist
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Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
As a Specialist, QA (CGT) at Lonza, you will support day-to-day Quality Assurance activities in accordance with approved SOPs and policies for a multi-product, cGxP contract manufacturing facility. You will play a key role in providing QA oversight for operations, compliance, and documentation, ensuring that products meet the highest quality standards and are released on time.
Benefits
An agile career and dynamic working culture.
An inclusive and ethical workplace.
Compensation programs that recognize high performance.
Daily company bus from the MRT location near your home to and from the Tuas site.
Fully paid medical insurance, with the option to enroll family members at partially subsidized premiums.
Access to Lonza’s full global benefits portfolio:
Responsibilities
Review executed batch records, logbooks, and documentation to ensure compliance with cGMP and GDocP.
Compile lot genealogy and disposition packages to drive timely product release.
Provide QA oversight for product status, shipping documents, and quality tag-out systems.
Support and approve deviation investigations, CAPA implementation, and timely closure of quality events.
Oversee and approve changes to operational documents (e.g., MBRs, SOPs, Forms, Logbooks).
Participate in QA shopfloor activities, changeovers, walkdowns, and audits (regulatory/customer).
Lead and coordinate site projects, investigations, and change controls as needed.
Qualifications
Degree or Diploma in Science or Engineering.
Experience in Quality Assurance within a cGMP manufacturing environment, ideally in Cell and Gene Therapy (CGT) or biopharmaceuticals.
Strong knowledge of cGMP, GDocP, and applicable regulatory requirements.
Hands‐on experience with batch record review, deviation management, and CAPA implementation.
Proven ability to lead investigations, change controls, and cross‐functional projects.
Effective communication and stakeholder management skills.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
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Process Automation Validation Engineer
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Job Opportunity: Validation Engineer - Process Automation
We are seeking a skilled validation engineer to join our team on a permanent role.
The successful candidate will have experience with process automation system commissioning and validation, as well as protocol development and review for process equipment. They will also possess strong communication skills and be able to manage validation projects effectively.
- Key Responsibilities:
- Commission and validate process equipment using the process automation system.
- Develop and review protocols for process equipment (IQ, OQ, PQ).
- Interface with clients and vendors as necessary.
- Manage validation projects from start to finish.
Requirements:
- 0-3 years of experience in validation/CQV.
- Strong knowledge of process automation systems and equipment commissioning/validation.
- Excellent communication and project management skills.
What We Offer:
- A challenging and rewarding role in a dynamic industry.
- Opportunities for professional growth and development.
- A collaborative and supportive work environment.