Manager NPI Process Validation

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 currently looking for a Process Validation Manager to be based in Penang, Malaysia.

Are you passionate about ensuring manufacturing processes are robust, compliant, and ready for scale? Do you enjoy leading teams, influencing cross-functional stakeholders, and driving validation excellence across complex NPI projects?

We are seeking an experienced Process Validation Manager to lead our Process Validation team within NPI. In this role, you will define validation strategies, develop organizational capabilities, and partner closely with R&D, Quality, Operations, and Manufacturing Transfer teams to accelerate successful product launches while ensuring compliance with global regulatory requirements.

This is an exciting opportunity for a leader who thrives in a dynamic, highly regulated manufacturing environment and enjoys building high-performing technical teams. You will play a key role in shaping validation methodologies, driving continuous improvement, and supporting Ambu's growth through successful product introductions and technology transfers.

Key Responsibilities

Your main responsibilities will include:

• 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 closely 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.

Suggested Candidate Profile

Skills

Skills and experiences can be earned in many different ways, and we understand that the best fit for the role cannot be prescribed on paper. You are, however, likely to succeed in this position if you:

• Hold a Bachelor's degree or higher in Engineering, Manufacturing, Quality, Life Sciences, or a related technical field.
• Have extensive experience in process validation, quality engineering, manufacturing engineering, or related functions within a regulated industry.
• Possess strong expertise in process validation methodologies, including IQ/OQ/PQ, MSA, Gage R&R, and statistical validation techniques.
• Have experience working within medical device manufacturing, NPI, or quality-focused environments.
• Demonstrate proven leadership experience in developing, coaching, and managing technical teams.
• Have strong stakeholder management and cross-functional collaboration skills, with the ability to influence across different levels of the organization.
• Are technically strong while maintaining a business-oriented mindset and understanding of commercial priorities.
• Are a strategic thinker and effective problem solver who can navigate complex challenges.
• Are an influential communicator who builds strong partnerships and drives alignment across functions.
• Are committed to quality, integrity, compliance, and continuous improvement.
• Are proficient in English, both written and verbal, and comfortable working in an international environment.