370 Pharmaceutical Engineer jobs in Thailand

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Responsibilities:

• Validating and evaluating new or modified processes, equipment systems, or facilities by:
• Conducting process characterization studies.
• Identifying key process variables that affect product quality.
• Determining critical equipment parts or features that impact process parameters and product quality.
• Performing hazard analysis, risk assessments, and other relevant process studies.
• Developing Validation Master Plans (VMP) for production processes by product, with necessary justifications based on conducted assessments and studies.
• Designing and developing validation protocols by:
• Establishing validation study features, including sampling, testing, and analytical methodologies.
• Directing validation activities such as protocol creation and testing.
• Preparing validation protocols for new or modified manufacturing processes, systems, or equipment.
• Studying product characteristics and customer requirements to determine validation objectives and standards.
• Conducting validation or qualification tests based on internal protocols and/or external standards by:
• Assisting in training operators and staff on validation protocols.
• Analyzing validation test data to determine system or process performance and identify root causes of production problems.
• Coordinating the implementation and scheduling of validation testing with relevant departments and personnel.
• Identifying deviations from established product or process standards and recommending corrective actions.
• Managing deviations and changes to ensure proper documentation and follow-up on corrective measures.
• Drawing samples of raw materials, intermediates, and finished products for validation testing.
• Conducting audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements.
• Procuring or developing automated validation test stations or other testing equipment and fixtures.
• Aligning facility validation strategies and policies with actual performance outcomes.

Qualifications:

• Bachelor's degree in Engineering or Science.
• Minimum 5 years of relevant experience in QC/QA.
• Strong knowledge of QC 7 tools, PFMEA, APQP, PPAP, 8D, SPC, and 5Why methodologies.
• Knowledge of ISO 13485 and ISO 14971 standards is an advantage.
• Proficient in using basic measurement devices.
• Good command of English (both spoken and written).
• Proficient in MS Office applications.

Responsibilities:

Process Validation

1. Lead activities linked to the validation and the maintenance of the validated state of manufacturing processes, Sealing process, Crimping process or concerning the operation process, particularly Computerized System, for the current and new ranges of products. This includes:

2. Participation in the issue and maintenance of the site's Validation Master Plan (VMP)

3. Participation in the issue and follow-up of the periodical validation schedule

4. Qualification of new equipment: write and/or review protocols and reports, lead tests

5. Validation of new processes: write and/or review protocols and reports, lead tests

6. Periodical review of the validated state of processes, planning of activities needed to maintain this state.

7. Creating and updating validation work instructions.

8. Establishing and updating the validation summary reports.

9. Participate in the qualification of equipment and the process validation, particularly sealing, crimping, assembly, thread treatments and printing processes, for the current and new products.

10. Review the mechanical tests methods validation.

11. Participate in the validation, the review, and the monitoring of suppliers/sub-contractors' validation reports and certifications.

Miscellaneous:

1. Evaluate impact assessment of change process

2. Establish URS for new Computerized system. Participate in writing URS for other processes.

3. Participate in FAT/SAT activities for new equipment.

4. Establish risk analysis for computerized system and participate in FMEA activities for other processes.

5. Participate in activities related to Change Control

6. Manage samples retained for real-time and accelerated aging studies and keep the aging master file up to date.

7. Support during audits.

Qualification:

• Education: University graduate or engineer in one of the following fields: industrial, bio-medical, chemistry, mechanical
• Working experience: At least 5 years up in the medical device, pharmaceutical industry or related
  
  industries.
• Specific skill/knowledge:
• Proficient in written and spoken English.
• Experienced in Equipment Qualification and/or Process validation.
• Knowledge of Computerized System Validation and GAMP5 guidance.
• Knowledge of Packaging processes.
• Knowledge of standards ISO 11607 and ISO
• Computer skills: word, excel, and power point (knowledge of Minitab would be a plus)
• Project management skills.
• General knowledge:
• Good team player and coordinator, able to work efficiently with deadlines.
• Diligent, meticulous, attention to the details
• Highly responsible and dependable
• Willingness and ability to learn fast.

Responsibilities:

Process Validation

1. Lead activities linked to the validation and the maintenance of the validated state of manufacturing processes, Sealing process, Crimping process or concerning the operation process, particularly Computerized System, for the current and new ranges of products. This includes:

2. Participation in the issue and maintenance of the site's Validation Master Plan (VMP)

3. Participation in the issue and follow-up of the periodical validation schedule

4. Qualification of new equipment: write and/or review protocols and reports, lead tests

5. Validation of new processes: write and/or review protocols and reports, lead tests

6. Periodical review of the validated state of processes, planning of activities needed to maintain this state.

7. Creating and updating validation work instructions.

8. Establishing and updating the validation summary reports.

9. Participate in the qualification of equipment and the process validation, particularly sealing, crimping, assembly, thread treatments and printing processes, for the current and new products.

10. Review the mechanical tests methods validation.

11. Participate in the validation, the review, and the monitoring of suppliers/sub-contractors' validation reports and certifications.

Miscellaneous:

1. Evaluate impact assessment of change process

2. Establish URS for new Computerized system. Participate in writing URS for other processes.

3. Participate in FAT/SAT activities for new equipment.

4. Establish risk analysis for computerized system and participate in FMEA activities for other processes.

5. Participate in activities related to Change Control

6. Manage samples retained for real-time and accelerated aging studies and keep the aging master file up to date.

7. Support during audits.

Qualification:

• Education: University graduate or engineer in one of the following fields: industrial, bio-medical, chemistry, mechanical
• Working experience: At least 5 years up in the medical device, pharmaceutical industry or related
  
  industries.
• Specific skill/knowledge:
• Proficient in written and spoken English.
• Experienced in Equipment Qualification and/or Process validation.
• Knowledge of Computerized System Validation and GAMP5 guidance.
• Knowledge of Packaging processes.
• Knowledge of standards ISO 11607 and ISO
• Computer skills: word, excel, and power point (knowledge of Minitab would be a plus)
• Project management skills.
• General knowledge:
• Good team player and coordinator, able to work efficiently with deadlines.
• Diligent, meticulous, attention to the details
• Highly responsible and dependable
• Willingness and ability to learn fast.

Our client is a Medical Device Manufacturing Industry.

Position: Senior Validation Engineer (Full Loop)

Work Type: Monday Friday (5 Days/Week) Full-time

Location: Lamphun, Thailand Travel Requirement: 10-20%

Job Summary:

We are seeking an experienced Senior Validation Engineer to lead and manage validation activities, ensuring compliance with regulatory standards and company goals. This role oversees validation testing, documentation, and process improvement efforts while coaching and guiding team members.

Key Responsibilities:

• Lead and manage validation teams to ensure timely and accurate completion of validation projects.
• Develop, implement, and maintain validation systems in compliance with regulatory and internal standards (e.g., ISO13485, FDA, EU).
• Provide technical leadership and coaching to ensure quality of validation work and continuous team development.
• Ensure all validation activities support regulatory and compliance requirements.
• Analyze and understand process control systems to support manufacturing improvements.
• Resolve performance or process issues to ensure targets are met.
• Collaborate with cross-functional teams including Quality, Engineering, and Production.
• Perform additional tasks as assigned to support departmental success.

Qualifications:

• Bachelors or Masters degree in Engineering, Science, or related field (e.g., Industrial Engineering, System Engineering, Chemical, Food Science, Pharmaceutical).
• 3-5 years of experience in Validation, process control, or manufacturing improvement.
• Experience in the medical device industry with knowledge of regulatory requirements (ISO13485, FDA, EU MDR) is highly preferred.
• Strong understanding of cleanroom and production environment standards.
• Experience with Lean Manufacturing and continuous improvement initiatives.
• Excellent problem-solving, analytical, and organizational skills.
• Strong leadership, team collaboration, and interpersonal communication skills.
• Proficient in validation tools/software such as Minitab and Microsoft Office.
• Good written and spoken English communication and presentation skills.
• Able to travel domestically up to 10-20%.

Position: Senior Validation Engineer

Location: Lad Krabang, Bangkok, Thailand

About the Role:

Our client, a leading medical device organization, is looking for a Senior Validation Engineer to join their Quality team. This role focuses on ensuring manufacturing processes and equipment are fully validated and compliant with industry standards. You will work with both current and new product lines, particularly on computerized systems, sealing, crimping, assembly, and printing processes.

Key Responsibilities:

• Lead validation activities and maintain the validated state of manufacturing processes and equipment.
• Develop, review, and execute validation protocols and reports for new equipment and processes.
• Maintain and update the Validation Master Plan (VMP) and periodic validation schedules.
• Participate in equipment qualification and process validation, including mechanical testing methods.
• Review validation documentation from suppliers and subcontractors.
• Conduct impact assessments for process changes and establish User Requirement Specifications (URS) for new computerized systems.
• Participate in FAT/SAT activities for new equipment and contribute to risk analysis and FMEA for processes.
• Manage retained samples for real-time and accelerated aging studies, keeping the aging master file updated.
• Support internal and external audits related to validation activities.

Qualifications:

• University degree or engineering background in Industrial, Biomedical, Mechanical, or Chemistry fields.
• Minimum 5 years of experience in the medical device, pharmaceutical, or regulated industries.
• Expertise in Equipment Qualification (EQ) and Process Validation.
• Knowledge of Computerized System Validation (CSV) and familiarity with GAMP5 guidelines.
• Understanding of packaging processes and standards such as ISO 11607 and ISO 13485.
• Strong project management skills and proficiency in MS Office (Word, Excel, PowerPoint); knowledge of Minitab is a plus.

Skills and Attributes:

• Excellent written and spoken English.
• Detail-oriented, diligent, and highly organized.
• Strong team player and effective coordinator.
• Responsible, dependable, and proactive in problem-solving.
• Fast learner, adaptable, and able to work efficiently under deadlines.

Why Join:

• Be part of a dynamic team in a highly regulated and innovative environment.
• Opportunity to work on cutting-edge validation projects and contribute to product quality and compliance.

Contact: Piyaporn S.

Email

Mobile

Role Overview :

The Senior Validation Engineer is responsible for overseeing a team dedicated to validation, ensuring all aspects of validation, testing, and documentation are completed in a timely and efficient manner. He or She will ensure that validation strategies are aligned with organizationalgoals and that quality systems are maintained throughout all processes and strategic activities.

Duties and Responsibilities :

(1) Leadership: Manage validation activities in teams, providing guidance and support to ensure successful project outcomes.

(2) System: Develop and maintain the validation system for team to meet current regulatory requirements, internal global standards, and industry best practices.

(3) Regulatory Compliance: Ensure the successful delivery of validation requirements for regulatory compliance projects in collaboration with the team.

(4) Process understanding: Deep dive into process control studying typically involves gaining a comprehensive understanding.

(5) Review and Coaching: Perform reviews of all validation work, providing coaching and support teams to ensure quality and accuracy.

(6) Problem Solving and Performance Management: Proactively manage and resolve any constraints or performance issues, ensuring that business unit performance aligns with established targets.

(7) Additional Tasks: Perform additional tasks as assigned by superiors, contributing to the overall success of the department.

Requirements

Academic Qualifications

• Bachelor's up to master's degree in engineering, Science or Health (industrial engineering, system engineering, chemical, food science, pharmaceutical).

Experience

• 3-5 years of working experience in validated company, process control or improvement manufacturing.
• Experience in medical device, strong knowledge of regulatory requirements and guidelines (ISO13585), including FDA and EU regulations are preferred.
• Math skills, analytical skills, teamwork, familiarity with Basic software and field specific software such as Minitab.

Skills

• Good in written communication and presentation skills.
• Good command in spoken and written English.
• Process and detail oriented, including strong interpersonal and prioritization skills.
• Lean manufacturing experience with a continuous improvement mindset.
• Experience work with teams.
• Strong communication and interpersonal skills

By submitting your application, you consent to HOYA Group collecting, disclosing, and retaining your personal data for employment assessment and verification purposes.

If you are shortlisted, we will contact you within three weeks of your application. Thank you for your application and understanding.

Job Descriptions:

Celestica HPS Engineering team is seeking a highly motivated and self-driven candidate qualified for the position of Hardware Validation Engineer to help design and build market-leading Hardware Platform Solutions. The successful candidate will be responsible for engineering assignments related to hardware products as well as systems including Hardware validation of new products, updates to existing products, or sustaining current products.

•Support Hardware  and Software Team in bring up and validation of Networking, Storage, and Server products during NPI phase per Hardware validation Test Plan

•Setup the and manage Test Rack , Test equipment and Unit Under Test for hardware validation

•Work with cross-functional teams  to troubleshoot and address any hardware issues identified during validation

Qualifications:

• Bachelors Degree in Electronic Engineering, Computer Engineering, Telecom Engineering or equivalent.

• 0-5 years of experience with hardware testing and validation

• Familiar with electrical design tools such as Logic analyzer, Oscilloscopes

• Familiar with common communication protocol such as I2C, SPI, DDR, PCIe, USB, Ethernet, SATA, NVMe

• Hands-on lab debugging, diagnostic errors. Problem solving and corrective actions

• Familiar with Linux environment and Ethernet protocol

• Self-motivated with a strong multidisciplinary background.

Role Overview

The Senior Validation Engineer is responsible for overseeing a team dedicated to validation, ensuring all aspects of validation, testing, and documentation are completed in a timely and efficient manner. He or She will ensure that validation strategies are aligned with organizationalgoals and that quality systems are maintained throughout all processes and strategic activities

Duties and Responsibilities

1. Leadership: Manage validation activities in teams, providing guidance and support to ensure successful project outcomes.
2. System: Develop and maintain the validation system for team to meet current regulatory requirements, internal global standards, and industry best practices.
3. Regulatory Compliance: Ensure the successful delivery of validation requirements for regulatory compliance projects in collaboration with the team.
4. Process understanding: Deep dive into process control studying typically involves gaining a comprehensive understanding.
5. Review and Coaching: Perform reviews of all validation work, providing coaching and support teams to ensure quality and accuracy.
6. Problem Solving and Performance Management: Proactively manage and resolve any constraints or performance issues, ensuring that business unit performance aligns with established targets.
7. Additional Tasks: Perform additional tasks as assigned by superiors, contributing to the overall success of the department.

Requirement

Academic Qualifications

1. Bachelor's degree in Engineering, Sciences or Health (Industrial engineering, system engineering, chemical, food science, pharmaceutical).

Expereince & Skills

1. 3 - 5 years of working experience in process validation, process control or improvement manufacturing.
2. Experience in Medical Device, strong knowledge of regulatory requirements and guidelines (ISO13585), including FDA and EU regulations are preferred.
3. Math skills, analytical skills, teamwork, familiarity with Basic software and field specific software such as Minitab.
4. Good leadership, human relation, and accountability
5. Team player, Strong communication and interpersonal skills
6. Lean manufacturing experience with a continuous improvement mindset.
7. Good command in spoken and written English.

Role Overview

The Senior Validation Engineer is responsible for overseeing a team dedicated to validation, ensuring all aspects of validation, testing, and documentation are completed in a timely and efficient manner. He or She will ensure that validation strategies are aligned with organizationalgoals and that quality systems are maintained throughout all processes and strategic activities

Duties and Responsibilities

1. Leadership: Manage validation activities in teams, providing guidance and support to ensure successful project outcomes.
2. System: Develop and maintain the validation system for team to meet current regulatory requirements, internal global standards, and industry best practices.
3. Regulatory Compliance: Ensure the successful delivery of validation requirements for regulatory compliance projects in collaboration with the team.
4. Process understanding: Deep dive into process control studying typically involves gaining a comprehensive understanding.
5. Review and Coaching: Perform reviews of all validation work, providing coaching and support teams to ensure quality and accuracy.
6. Problem Solving and Performance Management: Proactively manage and resolve any constraints or performance issues, ensuring that business unit performance aligns with established targets.
7. Additional Tasks: Perform additional tasks as assigned by superiors, contributing to the overall success of the department.

Requirement

Academic Qualifications

1. Bachelor's degree in Engineering, Sciences or Health (Industrial engineering, system engineering, chemical, food science, pharmaceutical).

Expereince & Skills

1. 3 - 5 years of working experience in process validation, process control or improvement manufacturing.
2. Experience in Medical Device, strong knowledge of regulatory requirements and guidelines (ISO13585), including FDA and EU regulations are preferred.
3. Math skills, analytical skills, teamwork, familiarity with Basic software and field specific software such as Minitab.
4. Good leadership, human relation, and accountability
5. Team player, Strong communication and interpersonal skills
6. Lean manufacturing experience with a continuous improvement mindset.
7. Good command in spoken and written English.