Manufacturing Engineer

A leading organisation in Penang is enthusiastically searching for a passionate Manufacturing Engineer to join their vibrant Manufacturing Engineering team!

This is your chance to step into a role where your expertise will be celebrated and your impact will be felt across every corner of the manufacturing process. You’ll drive manufacturing excellence through process optimisation, equipment qualification, and technical problem-solving, all while championing automation initiatives and new product introductions in a highly regulated environment. The company’s culture thrives on collaboration, training opportunities, and supportive leadership—ensuring you’re surrounded by colleagues who share your commitment to teamwork and knowledge sharing. If you love continuous improvement and want to grow in an inclusive workplace that values your contributions, this opportunity promises excitement, professional development, and the satisfaction of helping create products that truly make a difference.

• Join a lively, collaborative team dedicated to operational excellence, quality improvement, and innovation in manufacturing processes—work alongside knowledgeable professionals who value mutual support and sharing expertise.
• Enjoy flexible working opportunities and ongoing training designed to help you flourish as a Manufacturing Engineer while maintaining a healthy work-life balance; your growth is always encouraged here.
• Your efforts will directly shape new product introductions, process optimisation, and automation projects within a regulated environment—develop your skills in GMP/cGMP compliance, Lean Manufacturing, Six Sigma methodologies, and advanced data analytics tools with real-world impact.

What you'll do:

As a Manufacturing Engineer in Penang you’ll dive into exciting projects that span the entire spectrum of manufacturing operations. Every day brings fresh opportunities: you’ll energise production efficiency while upholding rigorous quality standards. You’ll oversee the identification and commissioning of manufacturing equipment in line with regulatory requirements. As Engineering Process Owner for specific areas you’ll manage documentation updates and procedural improvements that spark operational excellence. Your involvement in new product introduction ensures launches are successful—and every criterion is met. By spearheading process optimisation initiatives like yield enhancement or waste reduction you’ll fuel continuous improvement efforts. Troubleshooting complex issues related to equipment or product quality will showcase your analytical skills and technical know-how. You’ll also play an integral part in supporting quality system activities such as CAPA or MRB reviews. Analysing data using statistical methods or SQL will help you uncover actionable insights for further improvements. Collaboration is at the heart of this role: you’ll connect with Operations, Quality Assurance, R&D, Supply Chain—and mentor engineers or technicians—making sure everyone is moving forward together.

• Take the lead on manufacturing engineering activities that propel production goals forward, uphold quality standards, drive operational excellence initiatives, and support broader business objectives across multiple manufacturing areas.
• Identify requirements for manufacturing equipment, specify technical needs, procure suitable machinery, install systems efficiently, qualify them according to cGMP regulations, and commission them for optimal performance.
• Act as the Engineering Process Owner for assigned manufacturing areas by overseeing documentation updates, procedure enhancements, bill of materials management, specification reviews, protocol development, and technical report generation.
• Support new product introduction (NPI) activities by collaborating with cross-functional teams to ensure products meet stringent quality criteria, delivery timelines, cost targets, and operational benchmarks.
• Drive process optimisation efforts by implementing quality improvement strategies, yield enhancement measures, waste reduction initiatives, and continuous improvement methodologies throughout the production lifecycle.
• Perform comprehensive qualification or validation activities for products, processes, equipment, and suppliers to ensure compliance with regulatory requirements and internal standards.
• Lead troubleshooting sessions and root cause analyses related to manufacturing processes, equipment malfunctions, or product quality issues; implement sustainable solutions that address underlying problems.
• Support CAPA (Corrective Action Preventive Action), NCEP (Non-Conformance Event Process), MRB (Material Review Board), and other quality system activities to maintain compliance and promote ongoing improvement.
• Analyse manufacturing data using statistical tools and SQL queries to identify trends or improvement opportunities; interpret findings to inform decision-making on process enhancements.
• Collaborate closely with Operations, Quality Assurance, Research & Development (R&D), Supply Chain teams, external suppliers, engineers, technicians, and production personnel; provide training and mentorship as needed.

What you bring:

To shine as a Manufacturing Engineer here you’ll bring rich experience from regulated manufacturing environments like medical device pharmaceutical healthcare sectors where strict industry standards are second nature. Your educational background includes an engineering degree relevant field paired with deep understanding core manufacturing processes validation techniques equipment qualification procedures reliability engineering principles continuous improvement methodologies like Lean Six Sigma. Hands-on expertise troubleshooting automated equipment across electrical mechanical pneumatic hydraulic servo domains will empower you to tackle challenges swiftly efficiently. Proficiency leveraging data analysis reporting tools especially SQL critical extracting interpreting operational information identifying trends driving informed decisions process enhancements. Familiarity supporting CAPA MRB NCEP activities conducting thorough root cause investigations implementing robust solutions ensures compliance ongoing improvement culture maintained throughout organisation. Project management skills strong communication stakeholder engagement capabilities vital collaborating diverse teams executing strategic initiatives successfully. Ability operate independently juggle competing priorities thrive dynamic settings demonstrates resilience adaptability professionalism expected this position. Experience mentoring junior staff promoting knowledge transfer skill advancement further strengthens communal spirit fosters supportive learning environment.

• Bachelor’s Degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Manufacturing Engineering or a related discipline is required for this position.
• Minimum 5-8+ years of experience working within Manufacturing Engineering or related functions in regulated environments such as medical device or pharmaceutical industries is highly preferred.
• Strong knowledge of manufacturing processes including process validation techniques (IQ/OQ/PQ), equipment qualification procedures under GMP/cGMP guidelines, reliability engineering principles and continuous improvement methodologies like Lean Manufacturing or Six Sigma.
• Hands-on troubleshooting experience with automated manufacturing equipment covering electrical systems, mechanical components, pneumatic controls, hydraulic mechanisms and servo technologies is essential.
• Proficiency in data analysis tools; working knowledge of SQL is required for extracting analysing interpreting manufacturing quality operational data from databases or business intelligence platforms such as MES ERP Power BI Tableau etc.
• Experience supporting CAPA MRB NCEP activities along with proven ability to lead root cause investigations implement sustainable solutions addressing underlying issues effectively.
• Excellent project management skills demonstrated through successful execution of capital projects automation initiatives capacity planning programmes regional international assignments etc.
• Outstanding communication presentation stakeholder management abilities enabling effective collaboration across cross-functional teams including Operations Quality R&D Supply Chain external suppliers engineers technicians production personnel etc.
• Ability to work independently manage multiple priorities adapt quickly within fast-paced environments while maintaining attention detail commitment high standards compliance safety protocols industry regulations.
• Experience mentoring guiding engineers technicians fostering knowledge sharing skill development within team setting willingness travel internationally when required.

What sets this company apart:

This organisation stands out for its unwavering commitment to operational excellence within the highly regulated landscape of medical device manufacturing. Employees benefit from flexible working opportunities designed to accommodate individual needs while maintaining productivity. The company places significant emphasis on training opportunities—ensuring every team member has access to resources that facilitate personal growth professional development throughout their career journey. Supportive leadership creates an inclusive atmosphere where collaboration knowledge sharing are not just encouraged but celebrated; your contributions are valued recognised at every stage. The workplace culture prioritises safety compliance high standards resulting products trusted globally for their reliability effectiveness positive impact on patient outcomes healthcare advancements. By joining this team you become part network passionate professionals united common purpose delivering exceptional results together nurturing each other’s success along way.

What's next:

Ready to energise your career as a Manufacturing Engineer in Penang? This is your moment—step up and make an impact!

Apply today by clicking on the link provided or email me at TengHong.Khoo@robertwalters.com.my to discuss this new opportunity.

Do note that we will only be in touch if your application is shortlisted.

Agensi Pekerjaan Robert Walters Sdn Bhd
Business Registration Number : 729828-T
Licence Number : JTKSM 423C