Officer Filters

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.