Validation Engineer Supervisor

PT. PETERS SURGICAL INDONESIA; Depok; On-site; IDR 200.000.000 - 300.000.000; Full time

Job summary

A medical device company in Indonesia is looking for an experienced Validation Engineer. You will lead validation activities, conduct FAT and SAT, and ensure compliance with ISO standards. The ideal candidate holds a Bachelor's Degree in a relevant field and has at least 5 years of experience in the Medical Device Industry, with strong communication and analytical skills.

Qualifications

• Minimum 5 years of experience in the Medical Device Industry as a Validation Engineer.
• Candidates with experience in the Pharmaceutical or Medical Device Industry are preferred.
• Able to meet deadlines and multitask.

Responsibilities

• Lead validation activities for manufacturing processes.
• Contribute to the development of the Validation Master Plan.
• Conduct Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).

Skills

Communication skills

Innovation

Ability to work under pressure

Education

Bachelor’s Degree in Industrial Engineering / Chemical Engineering / Mechanical Engineering

Tools

ISO 13485

FMEA

Factory Acceptance Testing (FAT)

Site Acceptance Testing (SAT)

Job description

Minimum Bachelor’s Degree in Industrial Engineering / Chemical Engineering / Mechanical Engineering / or related field;

Minimum 5 years of experience in the Medical Device Industry as a Validation Engineer; candidates with experience in the Pharmaceutical or Medical Device Industry are strongly preferred;

Able to work under pressure, meet deadlines, multitask, and demonstrate innovation;

Strong communication skills, diligent, honest, and responsible; candidates with at least passive proficiency in English are preferred;

Good understanding and knowledge of ISO 13485, CPAKB, and Halal Management Systems;

Experienced in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for new equipment;

Skilled in preparing risk analysis based on FMEA for computerized systems as well as other processes;

Capable of leading validation activities related to manufacturing processes for both existing and new products.

Responsibilities

Lead activities related to the validation and maintenance of the validated state of manufacturing processes, particularly computerized systems, for both current and new product ranges.
This includes:

Contributing to the development and maintenance of the site’s Validation Master Plan.

Assisting in the preparation and follow-up of the periodical validation schedule.

Qualifying new equipment: drafting and/or reviewing protocols and reports, and leading tests.

Validating new processes: drafting and/or reviewing protocols and reports, and leading tests.

Conducting periodic reviews of validated processes and planning activities required to maintain the validated state.

Creating and updating validation work instructions.

Establishing and updating validation summary reports.

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

Review and assess the validation of mechanical test methods.

Participate in the validation, review, and monitoring of supplier/subcontractor validation reports and certifications.

Develop User Requirement Specifications (URS).

Participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) activities for new equipment.

Conduct risk analysis for computerized systems and participate in Failure Mode and Effects Analysis (FMEA) activities for other processes.

Participate in Change Control activities.

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

Which of the following types of qualifications do you have?

How many years' experience do you have as a Validation Engineer?

Have you worked in a role which requires a sound understanding of Good Manufacturing Practices (GMP)?

Which of the following languages are you fluent in?

How would you rate your English language skills?