Impactful Process Validation Engineer - Medical Devices

HCLTech; Los Angeles (CA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

401(k) retirement plan

Paid time off

Paid holidays

Job summary

HCLTech is seeking a Process Validation Engineer to join our medical device manufacturing team. You will develop and execute IQ/OQ/PQ protocols, conduct DOE-based process characterization, and ensure compliance with FDA/ISO/GMP standards.

The role requires a Bachelor's in engineering and 3+ years in process validation within medical device or biosensor environments. You will collaborate with Manufacturing Engineering and Operations, train staff, and support audits.

Qualifications

• Bachelor's degree in Engineering field (biomedical/chemical/mechanical/industrial).
• 3+ years in process validation for medical devices or biosensors.
• Strong knowledge of DOE, SPC and statistical tools.
• Understanding of GMP/QMS regulations.

Responsibilities

• Develop and execute IQ/OQ/PQ protocols for critical manufacturing processes.
• Conduct process characterization using DOE and SPC.
• Perform Cp/Cpk studies and implement CAPA for low-capability processes.
• Define and maintain the PVMP.
• Prepare validation reports, risk assessments, PFMEAs, and process maps.
• Train technicians and operators on validated processes and control plans.

Skills

IQ/OQ/PQ protocols

DOE/SPC analytics

Validation methodologies

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's in Biomedical/Chemical/Mechanical/Industrial Engineering

Tools

JMP

Minitab

Job description

HCLTech is seeking a Process Validation Engineer to join our medical device manufacturing team. You will develop and execute IQ/OQ/PQ protocols, conduct DOE-based process characterization, and ensure compliance with FDA/ISO/GMP standards.

The role requires a Bachelor's in engineering and 3+ years in process validation within medical device or biosensor environments. You will collaborate with Manufacturing Engineering and Operations, train staff, and support audits.