Process Validation Manager, NPI & Transfers

Ambu; Penang; On-site; MYR 240,000 - 360,000; Full time

Job summary

Ambu A/S is seeking a Process Validation Manager to lead the Process Validation team in Penang, Malaysia. You will define validation strategies, partner with R&D, Quality, Operations, and Manufacturing Transfer to support scalable product introductions and technology transfers.

This role requires strong leadership, extensive experience in IQ/OQ/PQ, MSA, Gage R&R, and statistical validation, and a proven ability to drive continuous improvement in a regulated manufacturing environment.

Qualifications

• Bachelor's degree or higher in Engineering, Manufacturing, Quality, Life Sciences, or related technical field.
• Extensive experience in process validation, quality engineering, manufacturing engineering, or related functions within a regulated industry.
• Strong expertise in validation methodologies including IQ/OQ/PQ, MSA, Gage R&R, and statistical validation techniques.
• Experience in medical device manufacturing, NPI, or quality-focused environments.
• Proven leadership in developing, coaching, and managing technical teams.
• Strong stakeholder management and cross-functional collaboration skills.

Responsibilities

• Lead and develop the Process Validation team, providing coaching, mentoring, and technical guidance.
• Define and implement process validation strategies for new product introductions and manufacturing transfers.
• Ensure execution of process validation activities, including IQ, OQ, PQ, MSA, Gage R&R, and statistical validation studies.
• Collaborate with R&D, Quality, Operations, Manufacturing Engineering, and Manufacturing Transfer teams to ensure efficient project execution.
• Drive risk-based decision-making to balance compliance, product quality, operational performance, and business objectives.
• Establish and maintain validation standards, methodologies, and best practices that meet global regulatory and quality requirements.
• Identify and lead continuous improvement initiatives to enhance process capability, validation efficiency, and organizational competence.

Skills

Process validation

Quality engineering

Manufacturing engineering

Leadership

Stakeholder management

Cross-functional collaboration

IQ/OQ/PQ

MSA

Gage R&R

Statistical validation

Education

Bachelor's degree in engineering or related field

Tools

Job description

Ambu A/S is seeking a Process Validation Manager to lead the Process Validation team in Penang, Malaysia. You will define validation strategies, partner with R&D, Quality, Operations, and Manufacturing Transfer to support scalable product introductions and technology transfers.

This role requires strong leadership, extensive experience in IQ/OQ/PQ, MSA, Gage R&R, and statistical validation, and a proven ability to drive continuous improvement in a regulated manufacturing environment.