Senior Associate, Product Stewardship

HU11 Alcon Hungária Gyógyszerkereskedelmi Kft Company

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Johor, Malaysia Until 9/5/2026 H-1B sponsor history First posted April 17, 2026 Last posted July 7, 2026
Job description

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us?

The Sr. Associate, Manufacturing Science & Technology Engineering, is primarily responsible for leading research initiatives and optimizing project outcomes by developing and evaluating new production materials, equipment, and technologies. This role demands advanced technical skills, problem-solving abilities, and strict adherence to procedures.

Job responsibilities:


- Collaborate with process owner, Process Control and Technical Stewardship team to establish critical process parameter from manufacturing process and ensure robust control in place to sustain manufacturing process.
- Support/ lead quality investigations resulting from internal non conformance
- Responsible for supporting and improving existing processes through process monitoring, analysis, control, and the application of engineering principles.
- Provide the necessary data for the technical activities involved in transferring out a product, focusing on existing knowledge, through appropriate documentation and supporting at the receiving site.
- Partnership with Validation team for validation strategy alignment.
- Initiate and/or lead (case by case) the change controls to its products and related processes.

- Ensure alignment of (regulatory) timelines for technical changes (eg.DS), transfers or launch, major deviations.
- Lead/ support material changes/ 2nd source material feasibility study and qualification activities to sustain business/operation continuity.
- Support/ lead continuous improvement project to improve operation efficiency, effectiveness and improve product quality.

Minimum requirement:

- Minimum 5 years of working experience

- Bachelor/Master's in Chemistry / Science/ Engineering

- Working experience in pharmaceutical/medical device/regulated manufacturing plant

- With risk management and product life cycle management experiences in 
pharmaceutical/medical device/regulated manufacturing plant

- 3 years project management experience in leading cross functional team

- Understanding in ISO 13485 & ISO 14971, MDSAP & QMSR 

  

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About this role

Summary

Lead process improvement, validation, and regulatory compliance in medical manufacturing.

Job title

Senior Associate, Product Stewardship

Experience level

5+ years

Industry

medical device

Location requirements

Johor, Malaysia; remote work not specified

Salary

Not specified

Visa sponsorship

H-1B sponsor history

Management role

No

Skills & keywords

Required skills

chemistryproject managementregulatory standardsrisk managementproduct lifecycle

Preferred skills

None specified

Specializations

medical deviceregulatoryproduct lifecycleISO 13485ISO 14971
Locations

Structured locations inferred from the posting.

Johol, Negeri Sembilan, Malaysia

Work arrangement unknown City