Senior Manufacturing Engineer
Role Overview:
We are seeking an experienced Process Manufacturing Engineer with a strong background in packaging systems within the medical device or pharmaceutical industry. This role will focus on managing packaging processes for new product introductions, ensuring compliance with industry standards, and validating automated systems.
Key Responsibilities:
- Lead and manage packaging processes for new product introductions (NPI).
- Oversee packaging systems including trays, sealing, sterilisation, and labelling.
- Validate processes and equipment to meet regulatory and quality standards.
- Support automation initiatives for packaging lines and ensure smooth integration.
- Collaborate with cross-functional teams on equipment transfers and process improvements.
- Manage labelling systems, printers, and associated packaging documentation.
- Ensure compliance with GMP and ISO standards in a regulated environment.
Required Experience & Skills:
- 5+ years experience in manufacturing engineering within medical device or pharmaceutical environments.
- Strong knowledge of packaging systems, sealing, sterilisation, and automation.
- Experience with process validation, equipment qualification, and documentation.
- Familiarity with NPI, equipment transfers, and regulated industry standards.
- Hands-on experience with labelling systems and printers.
Preferred Skills:
- Exposure to medical device packaging equipment and automated systems.
- Knowledge of ISO 13485, FDA regulations, and GMP requirements.
- Strong problem-solving and project management skills.
Ideal Candidate Profile:
- Intermediate to senior level (approx. 5 years experience).
- Background in process engineering, packaging, and validation.
- Ability to manage end-to-end packaging processes for new products.
FAQs
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