Validation Engineer ( Medical Devices )

6 days ago Be among the first 25 applicants

This range is provided by HCLTech. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$33.17 / hr - $47.50 / hr

HCLTech is looking for a highly talented and self- motivated Instrument Qualification Engineer to join it in advancing the technological world through innovation and creativity.

Job Title : Instrument Qualification Engineer

Job ID : 1592996BR

Position Type : Full-time with HCLTech

Responsibilities

• Serve as the technical SME for qualification of analytical equipment in manufacturing setup
• Author and execute qualification protocols (URS, DQ, IQ, OQ, PQ) in accordance with GAMP 5, FDA 21 CFR Part 11, and EU Annex 11 requirements.
• Lead and support equipment lifecycle activities, including requalification, decommissioning, and periodic review.
• Ensure data integrity compliance in computerized systems interfaced with analytical instruments.
• Collaborate with Quality, Validation, Metrology, IT, and Lab teams to define qualification strategies for new and upgraded equipment.
• Maintain traceability between user requirements, functional specifications, and qualification deliverables.
• Provide guidance on change control and impact assessments for equipment modifications or upgrades.
• Support audits and inspections by presenting qualification documentation and providing SME-level responses.
• Drive continuous improvement in qualification practices and documentation templates across global sites.
• Bachelor's or Master's degree in Chemistry, Engineering, Life Sciences, or a related technical field.
• Experience in analytical equipment qualification, preferably in a GMP-regulated medical device or pharmaceutical environment.
• FDA regulations (21 CFR Parts 820, 210 / 211, 11)
• GAMP 5 and ISO 13485
• Data integrity principles (ALCOA+)
• Experience qualifying and maintaining Manufacturing equipment.
• Familiarity with electronic document systems, validation tools, and computerized system validation.

Preferred Requirements

Pay and Benefits

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 secure@hcltech.com for investigation.

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.

Seniority level

Employment type

Job function

Industries

Referrals increase your chances of interviewing at HCLTech by 2x

Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Get notified about new Qualification Engineer jobs in Skaneateles Falls, NY

Syracuse, NY $75,000.00-$85,000.00 2 weeks ago

Auburn, NY $100,000.00-$120,000.00 1 week ago

Syracuse, NY $75,000.00-$85,000.00 3 weeks ago

Syracuse, NY $75,000.00-$85,000.00 2 weeks ago

Syracuse, NY $100,000.00-$135,000.00 3 weeks ago

Syracuse, NY $75,000.00-$85,000.00 1 month ago

Syracuse, NY $75,000.00-$85,000.00 2 weeks ago

Greater Syracuse-Auburn Area $85,000.00-$125,000.00 1 month ago

Syracuse, NY $110,000.00-$140,000.00 4 hours ago

Entry-Level Substation Electrical Engineer

Syracuse, NY $76,000.00-$86,000.00 1 day ago

Syracuse, NY $128,024.00-$195,000.00 2 weeks ago

Electrical Controls Engineering Supervisor

Syracuse, NY $76,000.00-$113,000.00 1 month ago

Electrical Engineer – Building Systems Design

Syracuse, NY $100,000.00-$130,000.00 4 hours ago

Electrical Engineer – Building Systems Design

Auburn, NY $100,000.00-$130,000.00 4 hours ago

Syracuse, NY $70,000.00-$90,000.00 3 weeks ago

We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

J-18808-Ljbffr