Process Validation Engineer (Contractor - India/Ireland)

Position Overview:

We are seeking a highly skilled and experienced Process Validation Engineer to join our team on a contractor basis. This role will involve an initial period of 8-10 weeks in India, followed by working between India and Ireland. The successful candidate will play a pivotal role in relocating eight product families, which include stents and urology devices, to a new location. Experience with silicon extrusion would be a major advantage.

Key Responsibilities:

Relocation Project:

• Lead and manage the relocation of eight product families, ensuring a smooth transition and minimal disruption.

• Collaborate with cross-functional teams to plan and execute the relocation project.

• Ensure all regulatory requirements are met during the relocation process.

Process Validation:

• Develop and execute process validation protocols (IQ OQ PQ) for medical devices, including stents and urology devices.

• Conduct process validation studies to ensure compliance with regulatory standards.

• Analyze validation data, prepare validation reports, and address any non-conformances.

Team Leadership:

• Lead teams to characterize medical device processes and ensure high standards of quality and efficiency.

• Provide guidance and mentorship to team members.

Regulatory Compliance:

• Ensure all processes comply with ISO 13485, FDA regulations, and other relevant regulatory guidelines.

• Assist in the preparation and submission of regulatory documents as required.

Quality Assurance:

• Implement and maintain quality assurance processes to ensure product quality and compliance.

• Perform risk assessments and implement corrective and preventive actions (CAPA) as necessary.

Desired Experience:

• Minimum 8 years of experience in the medical device industry.

• Proven experience in leading teams to characterize medical device processes.

• Extensive experience in directly executing process validation (IQ OQ PQ).

• Strong background in writing protocols and process validation reports.

• Experience working with Class II and III devices (catheters and stents).

• Experience in moulding, extrusion, and milling processes.

• Experience in the extrusion of silicon is highly desirable.

Skills and Attributes:

• Excellent written and verbal communication skills.

• Strong attention to detail and analytical skills.

• Ability to work independently and as part of a cross-functional team.

• Willingness to travel and work between India and Ireland.