Packaging Engineer: Process Validation & Compliance

Straits Orthopaedics (Mfg) Sdn Bhd; Batu Kawan; On-site; MYR 60,000 - 90,000; Full time

Job summary

Straits Orthopaedics (Mfg) Sdn Bhd, located in Batu Kawan, Malaysia, seeks a candidate to lead and participate in process validation, lab analysis, and documentation for new products. The role requires experience in medical device manufacturing, ISO13485, and risk management practices.

Candidate should have a biology/chemistry background and be able to work at Teluk Kumbar and Batu Kawan by Q4 2025. The company exports to major markets and holds ISO and FDA registrations.

Qualifications

• Degree in biology, microbiology, chemistry, or chemical engineering.
• 3 years related experience in medical device/pharmaceutical manufacturing and related areas.
• Trained on ISO13485, ISO9001 and medical device regulatory requirements and risk management.
• Manufacturing process validation, microbial contamination sampling, root cause analysis and problem solving, risk assessment.
• Willingness to work in Teluk Kumbar and Batu Kawan by Q4 2025.

Responsibilities

• Lead, execute and participate in process, equipment and software validation activities.
• Study and analyze lab test results or reports.
• Create or design documentation for new product processes.
• Carry out process capability studies for equipment and processes.
• Establish and maintain pFMEA and work instructions.

Skills

Process validation

Root cause analysis

Problem solving

Documentation

Quality systems

Education

Degree in biology, microbiology, chemistry, or chemical engineering

Tools

ISO 13485

ISO 9001

FDA 21 CFR Part 820

Job description

Straits Orthopaedics (Mfg) Sdn Bhd, located in Batu Kawan, Malaysia, seeks a candidate to lead and participate in process validation, lab analysis, and documentation for new products. The role requires experience in medical device manufacturing, ISO13485, and risk management practices.

Candidate should have a biology/chemistry background and be able to work at Teluk Kumbar and Batu Kawan by Q4 2025. The company exports to major markets and holds ISO and FDA registrations.