Job Description:

Project Setup & Execution:
Lead the project for setting up a filter manufacturing line (e.g., pleated filters, capsule filters, depth filters).
Define layout and workflow for cleanroom and production areas as per ISO Class requirements.
Identify, evaluate, and oversee installation of machinery (pleaters, welders, integrity testers, etc.).
Coordinate with vendors, contractors, and internal stakeholders for utilities, HVAC, and cleanroom construction.
Prepare and implement project timelines, risk assessments, and commissioning plans.

Process Development:
Design and document manufacturing processes, work instructions, and SOPs.
Conduct process trials, validation batches, and ensure scalability to commercial production.
Support material selection, product design feasibility, and tooling development.

Compliance & Quality Assurance:
Ensure compliance with GMP,



ISO 13485/9001, and regulatory requirements.
Lead validation activities including IQ/OQ/PQ, cleanroom validation, and equipment calibration.
Implement and maintain quality control checkpoints throughout the setup.

Technical & Customer Support:
Provide pre- and post-sales technical support to customers on filter selection, usage, and troubleshooting.

Assist in validation studies (e.g., extractables/leachables, bacterial retention, integrity testing).

Prepare technical datasheets, presentations, and product literature.

Participate in customer audits, tech transfers, and product demonstrations.

Collaborate with sales and quality teams for continuous product improvement.

📌 Engineer Filter Kalla
🏢 Ami Polymer
📍 Kalla