Validation Engineer

HCLTech; Lakewood Township (NJ); On-site; USD 95,000 - 151,000; Full time

Job summary

HCLTech is seeking an IT professional to support system owners in generating and managing IT documentation for instrument qualification and computerized system validation in Baxter R&D environments.

Responsibilities include supporting laboratory IT systems, applying cGxP requirements, leading cross-functional projects, and handling qualification activities with proper documentation and change control processes.

Qualifications

• Solid understanding of IT functions related to instrument qualification.
• Experience or knowledge of pharmaceutical/biotech environments.
• Strong written and verbal communication skills.
• Strong organizational skills and ability to work independently or in teams.

Responsibilities

• Support IT activities for laboratory systems (AAS, GC, LC, MS, SEM, NMR, etc.).
• Learn and apply cGxP and SOP requirements and project procedures.
• Serve as IT project lead for intermediate scope projects with cross-functional teams.
• Assist with qualification of equipment and change controls; coordinate re-qualifications and retirements.
• Manage software/hardware documentation and archival for approved packages.

Skills

IT validation

Documentation

Communication (verbal/written)

Independent / team work

Education

BS degree in technical field

Tools

OpenLab ECM

Xybion Compliance Builder

ServiceNow

Job description

Job Summary

This position will have primary responsibility for supporting system owners with the generation and management of IT related documents for instrument qualification and computerized system validation process to ensure compliance with the associated regulations. These activities will focus on IT related functions involved with laboratory Analytical Instruments utilized in the engineering, chemistry, and information technology areas for Baxter R&D. All activities must be performed in compliance with internal Baxter Quality System procedures.

Key Responsibilities

Job description:

Job Summary

This position will have primary responsibility for supporting system owners with the generation and management of IT related documents for instrument qualification and computerized system validation process to ensure compliance with the associated regulations. These activities will focus on IT related functions involved with laboratory Analytical Instruments utilized in the engineering, chemistry, and information technology areas for Baxter R&D. All activities must be performed in compliance with internal Baxter Quality System procedures.

• Support IT related activities for all laboratory systems including Atomic Absorption, Gas Chromatographs, Liquid Chromatographs, Mass Specs, Electron Microscopes, NMR's, Engineering and Infuscale systems.
• Apply knowledge or quickly learn cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate.
• Serve as IT project lead with projects of intermediate scope and cross-functional teams.
• Set up and install/upgrade new PC's when needed for lab equipment
• Support IT functions for the qualification of new equipment, coordinate system change control requests and re-qualification activities, as well as manage systems retirements and periodic reviews.
• Support all labs in Round Lake including Techl, Tech2, DDEL, WG, and the Penicillin building that contain Validated Systems.
• Support Active Directory and Data Integrity project.
• Perform System Administrator duties for Agilent OpenLab ECM and Xybion Compliance Builder.
• Monitor the Service Now Help Desk ticketing system for any App related issues.
• Preforms IT related technical reviews of validation package deliverables.
• Support all Windows Operating Systems, including XP, Windows 7, 8, and 10.
• Support Macintosh as well as PC based systems.
• Management and archival of all software and/or hardware for approved package documents.
• Handle routine tasks timely, accurately.

Skill Requirements

• Solid understanding of IT functions related to the instrument qualification process.
• Direct or indirect industry knowledge.
• Ability to communicate effectively at all levels in verbal and written form, including technical/business writing.
• Excellent organizational skills.Ability to work independently or in teams, Proficient in Computer Software and hardware, Microsoft Word and Excel Must have excellent organization, oral and written communication skills.

Other Requirements

Education and/or Experience: Minimum BS degree in technical area or 6 years related experience within a pharmaceutical, biotechnology or related industry.

We offer:

Pay Range Minimum: $ 95,000 per year

Pay Range Maximum: $ 151,000 per year

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 [e-mail] 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.