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
Job ID: 1543881BR
Position Type: Full-time with HCL Tech
Location: Northridge, CA
Role/Responsibilities
Conceives, plans and executes manufacturing process validations plans and studies.
Adhere to the Change Control and Design Control requirements.
To create robust validation documents such as Master Validation Plans / Report, IQ, OQ, & PQ's
Being the lead on the writing and execution of IQ/OQ/PQ protocols.
RCH/PCH - Routing in MAP Agile & follow up till release.
Updating Control Plan (CP), Assembly Procedure (AP) & Traveler document (TD).
Preparing protocol & executing Test Method validation (TMV).
Validation experience using risk-based approach guidelines, international regulatory requirements, and standards.
Ensures that all activities are carried out in compliance with all regulations and laws governing business and quality operations.
Responsible for ensuring compliance with all local, national, international and company regulations, policies and procedures for Health, Safety and Environmental compliance.
Some previous experience in medical device or related regulated industry
Experience in project management and project leadership
Extensive experience in the preparation of technical documents
Proficient in PLM tools & Microsoft Office
Excellent written and oral communication skills
Attention to detail
Ability to work as a team
Manage your own time and workload
Excellent organizational skills
Qualifications & Experience
Minimum Requirements
Minimum 3-years' experience of working on manufacturing engineering validation activities.
Degree qualified - ideally science or engineering
Other further education and work experience may be considered
Pay and Benefits
Pay Range Minimum: $31.25 per hour
Pay Range Maximum: $50.96 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 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.