Process Validation Engineer

Job Title

Process Validation Engineer

112011

Full-time with HCLTech

• 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.

• 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.

• 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.
• Experience in the semiconductor industry for wafer production.

Pay Range Minimum: $38.46 per hour

Pay Range Maximum: $45.00 per hour

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  for investigation.

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.

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.