ROLE SUMMARY The Clean Room Production Incharge will own end-to-end clean room production operations for hip and knee implants — from ultrasonic cleaning through passivation and final packaging — ensuring output meets quality, regulatory, and delivery requirements. The role requires hands-on command of clean room equipment, strong documentation discipline (BMR/batch records), and working knowledge of validation, qualification, and production planning in a regulated medical device environment.

KEY RESPONSIBILITIES

- Plan, schedule, and supervise clean room production: ultrasonic cleaning, passivation, and final packaging of hip and knee implants.

- Operate, monitor, and troubleshoot clean room equipment (ultrasonic cleaners, passivation tanks, laminar flow units, packaging/sealing machines) and ensure preventive maintenance schedules are followed.

- Maintain and review Batch Manufacturing Records (BMR) for accuracy, completeness, and compliance before batch release.

- Implement and monitor the Quality Plan on the shop floor; ensure in-process checks and clean room classification (viable/non-viable monitoring) are met.

- Drive daily/weekly production planning in coordination with the Machine Shop Incharge to meet delivery timelines.

- Lead and support Equipment Qualification (IQ/OQ/PQ) and Process Validation activities for clean room processes.

- Maintain clean room discipline: gowning protocols, environmental monitoring, contamination control, and housekeeping per SOPs.

- Coordinate with QA/RA on non-conformances, deviations, CAPA, and batch release documentation.

- Train, supervise,



and evaluate clean room production operators; enforce SOP and GMP compliance on the floor.

- Maintain traceability records (lot/batch, device history records) as required under ISO 13485 / MDR / applicable regulatory framework.

REQUIRED QUALIFICATIONS & SKILLS

- Diploma / B.E. / B.Tech (Mechanical, Biomedical, or related) or equivalent; science graduates with relevant industry experience also considered.

- 4–6 years of experience in clean room production within orthopedic implants, medical devices, or a similarly regulated manufacturing environment.

- Working knowledge of ultrasonic cleaning, passivation, and sterile/clean packaging processes for metallic implants.

- Practical exposure to clean room classifications (ISO 14644 / Grade C-D), gowning, and contamination control.

- Experience maintaining Batch Manufacturing Records and working within a documented Quality Management System (ISO 13485).

- Familiarity with equipment/process validation and qualification (IQ/OQ/PQ) concepts and documentation.

- Strong production planning, shop-floor problem-solving, and team supervision skills.

- Positive documentation, communication, and cross-functional coordination skills (with QA/RA and Machine Shop).

PREFERRED (GOOD TO HAVE)

- Prior experience specifically with hip/knee or other orthopedic implant manufacturing.

- Exposure to regulatory audits (USFDA, CE/MDR, CDSCO) from a production standpoint.

- Basic understanding of relevant standards (ISO 13485, ISO 14644, ASTM standards for implant surface finishing/passivation).

Pay: ₹500,000.00 - ₹700,000.00 per year

Benefits

- Provident Fund

Work Location: In person

📌 Clean Room Production Incharge (Ulhasnagar)
🏢 Dabir Precitech Pvt.ltd
📍 Ulhasnagar