Engineer/Sr. Engineer - Validation (Pharma Validation)

B. Braun Group
Penang
MYR 150,000 - 200,000
Job description

You're an important part of our future. Hopefully, we're also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That's why we would like to keep developing our company with you. Keeping your future in mind, we're making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise.

  • Coordinate/ Support Head of Validation Team in the execution of Qualification and Validation in compliance to regulatory requirements by/ with/as in maintaining the Master Validation Plan and update of Validation Program and preparation and maintenance of qualifications and validations procedures and documents.
  • Acts as the key member in Pharma Process Risk Analysis Team to ensure compliance status for measuring devices used for validation in its handling/ maintenance and calibration and direct and follow up on corrective/ preventive actions related to validation/ compliance issue .
  • Also responsible as the Coordinator/ Trainer with respect to Pharma validation / qualification training needs , supporting production in trial/ test runs for production machines/ process to establish process parameter , support production projects as key member in Projects Management and responsible for performance of internal quality inspections.
  • Incumbent is also responsible as change control Coordinator and coordinate and assist in qualification and validation activities involving projects for Asia Pacific region by sharing expertise and Resource planning & management.
  • For the Sr. position , the incumbent will also hold the responsibility in heading the Validation Team in the execution of Qualification and Validation in compliance to regulatory requirements in Pharma Plant , Project Manager for Pharma Projects and perform performance of supplier qualification audit and internal audit.

Requirements:

  • Degree in Science/ Engineering background; e.g. Biotech, Microbiology, Mechanical.
  • Having at 2-3 years of validation experience.
  • Well verse in regulatory requirement under PICs (Pharmaceutical Inspection Convention scheme) in qualification and validation and EUGMP.
  • Will be added advantage if having sterile manufacturing background.
  • Will be added advantage if experience working in the medical or pharmaceutical Industries.

Become part of a corporate culture that actively promotes constructive exchanges between colleagues, customers and partners. Work with us to improve people's lives in the long term. We can offer you interesting, varied tasks and excellent opportunities for advancement, as well as an attractive salary with extensive benefits, all within a dynamic family-owned company.

Contact: B. Braun Medical Ind. Sdn. Bhd. | Sheryn | 04-632 4522

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