Technical Lead: Manufacturing Process Validation

HCL Technologies Limited; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

HCL Technologies Limited is seeking a Technical Lead specializing in Manufacturing Process Planning to guide validation programs and drive best practices on the production floor. You will lead IQ/OQ/PQ activities, perform process characterization, and mentor engineers to ensure compliant, efficient processes.

In this role, you will partner with Manufacturing Engineering and Operations to implement validated processes, support audits with robust validation documentation, and help optimize yield,

Qualifications

• Bachelor’s degree in Biomedical, Chemical, Mechanical, Industrial, or related Engineering field.
• 3+ years of experience in process validation within a medical device, diagnostics, or biosensor environment.
• Strong knowledge of DOE, SPC, statistical tools (JMP/Minitab), and validation methodologies.
• Understanding of regulated medical device manufacturing and QMS requirements.

Responsibilities

• Develop and execute IQ/OQ/PQ protocols for critical manufacturing processes.
• Conduct process characterization using DOE, SPC, and statistical modeling.
• Perform Cp/Cpk studies and implement corrective actions for low-capability processes.
• Define and maintain the Process Validation Master Plan (PVMP).
• Prepare validation protocols, reports, risk assessments, PFMEAs, and process maps.
• Optimize process parameters for yield, throughput, and quality.
• Lead root‑cause analysis and CAPA activities related to process deviations or excursions.
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and GMP regulations.
• Support internal, external, and regulatory audits by providing process validation documentation.
• Work with Manufacturing Engineering and Operations to implement validated processes on the production floor.
• Train technicians and operators on validated processes and control plans.

Skills

Process validation

DOE

SPC

Root-cause analysis

Education

Engineering degree (Biomedical/ Chemical/ Mechanical/ Industrial)

Tools

JMP

Minitab

Job description

HCL Technologies Limited is seeking a Technical Lead specializing in Manufacturing Process Planning to guide validation programs and drive best practices on the production floor. You will lead IQ/OQ/PQ activities, perform process characterization, and mentor engineers to ensure compliant, efficient processes.

In this role, you will partner with Manufacturing Engineering and Operations to implement validated processes, support audits with robust validation documentation, and help optimize yield,