Validation SME

We are HCLTech, one of the fastest-growing large tech companies in the world and home to 219,000 people across 60 countries, supercharging progress through industry-leading capabilities centered around Digital, Engineering and Cloud. ( )

The driving force behind that work, our people, are diverse, creative, and passionate, raising the bar for excellence on a regular basis. We, in turn, work hard to bring out the best in them as we strive to help them find their spark and become the best version of themselves that they can be. If all this sounds like an environment you ll thrive in, then you re in the right place.

We are looking for a highly talented and self- motivated Validation SME to join us on our journey in advancing the technological world through innovation and creativity.

Job Title: Validation SME

Job ID: 2662612

Position Type: Full-time

Location: Waltham, MA (Hybrid)

Role/Responsibilities

• Validation Plan Development:
  Creating comprehensive validation plans that outline the steps for verifying equipment performance.
  Risk Assessment:
  Identifying and assessing potential risks associated with using the equipment.
  IOQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification):
  Conducting these essential tests to verify equipment installation, functionality, and performance under normal operating conditions.
  Data Analysis and Reporting:
  Analyzing validation data and preparing reports to document findings and ensure compliance.
  Documentation:
  Maintaining detailed records of validation activities, including validation protocols, reports, and SOPs.
  SOP Development:
  Developing and maintaining Standard Operating Procedures for equipment operation and maintenance.
  Calibration and Maintenance:
  Ensuring equipment is calibrated and maintained according to established procedures.
  Troubleshooting:
  Identifying and resolving issues related to equipment performance.

Qualifications & Experience

Minimum Requirements

• Technical Knowledge: Strong understanding of laboratory instrumentation, validation principles, and relevant regulations.
  Analytical Skills: Ability to analyze data, identify trends, and interpret results.
  Problem-Solving Skills: Ability to identify and resolve technical issues.
  Documentation Skills: Strong written communication and report writing skills.
  Attention to Detail: Accuracy and meticulousness in recording data and documenting findings.
  Good Communication Skills: Ability to effectively communicate with colleagues and stakeholders.
  Experience: Relevant experience in a laboratory environment, ideally with experience in instrument validation or related roles.

Pay and Benefits

Pay Range Minimum: $65,000

Pay Range Maximum: $122,000

HCLTech 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.

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.