Join a leading organisation within the medical device packaging and manufacturing sector as an Integration (Process Validation) Engineer.
This position plays a critical role in supporting regulated manufacturing operations, process validation, and new product introductions within the medical packaging, flexible film converting, and healthcare manufacturing industry. This is an excellent opportunity for an engineering professional with expertise in validation, quality systems, and process optimisation within a highly regulated environment.
What You'll Be Doing:
- Develop and execute IQ, OQ, and PQ validation protocols and reports for manufacturing processes and equipment.
- Lead process validation activities across flexible film converting, pouch manufacturing, heat sealing, RF welding, printing, and labelling operations.
- Conduct process capability studies and statistical analysis to support validation and continuous improvement initiatives.
- Define process windows, critical process parameters, and acceptance criteria.
- Support new product introductions from development through commercial production.
- Drive process improvement projects focused on quality enhancement, waste reduction, efficiency, and throughput improvements.
- Lead root cause investigations and implement corrective and preventive actions.
- Ensure compliance with FDA Quality System Regulations, ISO 13485, GMP requirements, and customer quality standards.
- Support internal audits, customer audits, and regulatory inspections.
- Manage validation schedules, project timelines, and engineering deliverables.
- Act as a technical liaison between customers, operations, quality, and engineering teams during product launches and process transfers.
- Facilitate technical reviews, production trials, customer visits, and validation planning activities.
What We're Looking For:
- Bachelor's degree in Engineering or a related technical discipline.
- Minimum 3 years' experience within a regulated manufacturing environment.
- Proven experience leading process validation activities using IQ/OQ/PQ methodologies.
- Strong knowledge of FDA 21 CFR Part 820, ISO 13485, GMP requirements, and quality systems.
- Experience with statistical analysis, risk management, and root cause investigation tools.
- Experience within medical device packaging, flexible film converting, or related regulated manufacturing environments preferred.
Interested? Reach out to Alchemy Global Talent Solutions today.