Validation Engineer

Main duties and responsibilities:

Process validation

1. Participate in activities linked to the validation and maintaining the validated state of

manufacturing processes, particularly sealing, crimping, assembly, cleaning, injection

processes, for the current range of products. This includes:

• Qualification of new equipment: write protocols and reports, lead tests
• Validation of new processes: write protocols and reports, lead tests
• Periodical review of the validated state of processes

2. Participate in the qualification of equipment and the process validation, particularly sealing,

crimping, assembly, cleaning, injection processes, for new products.

Software Validation

1. Participate in activities linked to the verification / validation of software related to

manufacturing processes.

2. Participate in the verification / validation of software related to other processes

(non-manufacturing)

Qualification:

Education: Bachelor of engineering in following fields: industrial, bio-medical, chemistry, mechanical.

Working experience: 0-3 years in experience.

Specific skill/knowledge:

• Proficient in written and spoken English.
• Experienced in Equipment Qualification and/or Process validation a plus
• Knowledge of manufacturing processes related to medical devices a plus
• Knowledge of standards ISO 11607 and ISO 13485 a plus
• Computer skills: word, excel, and power point (knowledge of Minitab would be a plus)

General knowledge:

• Good team player able to work efficiently with deadlines.
• Diligent, meticulous, attention to the details.
• Highly responsible and dependable.
• Willingness and ability to learn fast.