Equipment Validation Engineer

Job Title

Equipment Validation Engineer

115852

Full-time with HCLTech

• Experience in medical device manufacturing of 3D printing, equipment and commissioning is required
• Experience in process/Equipment validation planning, execution and reporting is required
• Strong technical writing skills related to process validation documentation as well as manufacturing process documentation (work instructions, standard operating procedures, etc.) is required
• Create and maintain validation documentation, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols and reports.
• Collaborate with Manufacturing, Quality Assurance, Regulatory Affairs, and Equipment Engineering to qualify new machines and implement change controls.
• Design, execute, and document calibration, metrology, and gauge R&R activities; ensure traceability of measurement equipment.
• Analyze process data (statistical methods, capability studies like Cp/Cpk, Gage R&R) to demonstrate repeatability, accuracy, and process control.
• Generate, review, and approve validation reports; ensure closure of deviations, CAPAs, and non-conformances.

• Education:
  
  Bachelor’s degree in mechanical engineering, Manufacturing Engineering, Biomedical Engineering, or related discipline.
• Experience:
  
  2–5 years in manufacturing and equipment validation in a regulated environment (Med Tech, pharma, or healthcare devices).
• Regulatory & Standards:
  Strong knowledge of ISO 13485, GMP, and 21 CFR Part 820; familiarity with risk management (ISO 14971) and validation concepts (IQ/OQ/PQ).
• Technical
  
  Skills:
• Proficiency in developing and executing IQ/OQ/PQ protocols.
• Experience with metrology, calibration, and measurement system analysis.
• Knowledge of CNC machines, CAM software, and basic CNC programming concepts.
• Statistical tools experience (Minitab, JMP, or similar) for process capability studies.
• Document control and eQMS systems experience (e.g., Master Control, ETQ, etc.).
• Communication:
  Strong written and verbal communication; ability to write clear validation documentation and present findings to cross-functional teams.

Pay Range Minimum: $42.0 per hour

Pay Range Maximum: $47.00 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.