Process Validation Engineer

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 looking for a highly talented and self- motivated Process Validation Engineer to join it in advancing the technological world through innovation and creativity.

Job Title: Process Validation Engineer

Position Type: Full-time with HCLTech

Role/Responsibilities:

• Develop and execute IQ/OQ/PQ protocols for critical manufacturing processes.
• Conduct process characterization using DOE, SPC, and statistical modeling.
• Perform process capability studies (Cp/Cpk) 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.

Qualifications Required

• 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.

Preferred

• Experience with blood glucose sensor processes or electrochemical sensor manufacturing.
• Six Sigma Green Belt or Black Belt certification.
• Experience with automated or semi-automated process lines.

Compensation and Benefits

A candidate's pay within the range will depend on their work location, skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year.

How You'll Grow

At HCLTech, we offer continuous opportunities for you to find your spark and grow with us. We want you to be happy and satisfied with your role and to really learn what type of work sparks your brilliance the best. Throughout your time with us, we offer transparent communication with senior-level employees, learning and career development programs at every level, and opportunities to experiment in different roles or even pivot industries. We believe that you should be in control of your career with unlimited opportunities to find the role that fits you best.

HCL is an equal opportunity employer, committed to providing equal employment opportunities to all applicants and employees regardless of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical disability or genetic information, military or veteran status, or any other protected classification, in accordance with federal, state, and/or local law. Should any applicant have concerns about discrimination in the hiring process, they should provide a detailed report of those concerns to [e-mail] for investigation.