Department: Industrialization & Validation   

Hierarchical level: 4

Hierarchical reporting: I&V Manager      

Functional reporting: I&V Manager                       

Subordinate: N/A

Main duties and responsibilities

Process Validation

•  Participate in and/or lead activities linked to the validation and maintaining the validated state of manufacturing processes, for the current range of products. This includes:
  • Issue and Maintenance of the site's Validation Master Plan
  • Issue and follow-up of the periodical validation schedule
  • Qualification of new equipment: write and/or review protocols and reports, lead tests
  • Validation of new processes: write and/or review protocols and reports, lead tests
  • Periodical review of the validated state of processes, planning of activities needed to maintain this state
• Participate and/or lead the qualification of equipment and the process validation for new products.

Software Validation

• Participate in and/or lead activities linked to the verification / validation of software related to manufacturing processes.
• Participate in the verification / validation of software related to other processes (non-manufacturing)

Miscelaneous

• Participate in definition of URS for new equipment
• Participate in FAT/SAT activities for new equipment
• Participate in FMEA activities
• Participate in activities related to Change Control

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 written and spoken in English.
• Experienced in Equipment Qualification and/or Process validation
• Knowledge of packaging, cleaning and/or Ethylene-Oxide Sterilization processes will be a plus.
• 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

Peters Surgical International Co., Ltd.

227 Ladkrabang Industrial EPZ Zone 3,
Chalongkrung Road, Lamplatew,Ladkrabang, Bangkok 10520

Presentation company

With more than 800 employees worldwide, Péters Surgical Group is a French multinational company founded in 1926. Péters Surgical’s mission is to improve the quality of patient care and to contribute to the success of surgical procedures.

Present in more than 90 countries, with major manufacturing sites in France, India and Thailand, Péters Surgical designs, manufactures and distributes surgical single use-devices in 5 strategic product ranges: sutures, hemostatic clips and VTO, meshes, surgical glue and laparoscopic instruments. Péters Surgical is currently the 4th largest surgical suture company in the world and the hemostatic clips leader in Europe. Every 5 seconds, 4 Péters Surgical products are used all over the world.

Péters Surgical has been producing medical devices in Thailand since 1995. We operate under the industry International Standard ISO 13485:2016. Our products meet international quality certifications and registrations (CE & FDA).