Validation Engineer

***NO Visa Sponsorship/ No H1Bs/ No C2Cs***

Overview

Our client, a US Fortune 250 company and a global medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an accomplished Process Development Engineer

Job Title: Validation Engineer

Location: El Paso Texas 79912

Duration: 12-Month Contract (Possible Extension)

Pay Rate: $40/hr – $45/hr (depending on experience)

Work Schedule: On-site

Relocation Expenses/ Assistance: NO

NO Visa Sponsorship/ No H1Bs/ No C2Cs

Position Summary

This role leads technical support for new product transfers and product development projects. The Engineer is responsible for interpreting, planning, organizing, and executing technical assignments across diverse manufacturing and development requirements.

Key Responsibilities

• Coordinate and support suppliers for manufacturing of custom equipment and tooling
• Manage purchase, delivery, and installation of equipment and tooling
• Develop and execute IQ/OQ protocols and reports
• Perform test method validation and Gage R&R studies
• Generate and obtain approval for SOPs and manufacturing procedures
• Execute component qualifications
• Develop and execute PQ and PPQ protocols and reports
• Conduct manufacturing capacity analysis
• Lead process characterization and Design of Experiments (DOE)
• Prepare documentation and justification for capital projects
• Ensure compliance with cGMP, quality standards, and internal policies
• Perform additional duties as assigned

Required Qualifications (Must Have)

• Bachelor’s degree in Engineering
• 5 years of experience in:
• Manufacturing
• New product transfers
• Product and/or process development
• Experience in Medical Device or Pharmaceutical industry
• Risk Management experience, including FMEA (Failure Mode and Effects Analysis)
• Experience developing technical documentation, including SOPs, validation protocols, and process documentation
• Strong understanding of Geometric Dimensioning and Tolerancing (GD&T)
• Experience developing and executing validation protocols (IQ, OQ, PQ)
• Strong technical writing skills
• Knowledge of GMP, ISO, EHS, and statistical regulations
• Proficiency in Microsoft Office (Word, Excel, PowerPoint)
• Experience with MS Project
• Minitab proficiency
• Bilingual (English and Spanish – written and verbal)

Preferred Qualifications (Nice to Have)

• Experience with CAD/CAM software (SolidWorks, AutoCAD)
• Lean / Six Sigma certification or training
• Project Management certification or training
• Engineering certification (EIT or PE)

Technical Experience

• Qualification and validation (IQ/OQ/PQ)
• Test method validation and Gage R&R
• Process characterization and DOE
• Manufacturing line design and capacity analysis
• Equipment and tooling design
• Equipment installation and preventive maintenance procedures
• Root cause analysis and investigations
• SOP and manufacturing procedure development, including change control
• Product financials and supply chain structure design
• OEE integration, vertical startup, and zero-loss methodologies

Recruiter Contact Info

Sajag Bhardwaj

Email: sajag.bhardwaj@ameritconsulting.com

www.ameritconsulting.com

I'd love to talk to you if you think this position is right up your alley, and assure prompt communication, whichever direction. If you're looking for rewarding employment and a company that puts its employees first, we'd like to work with you.

Company Overview:

Amerit Consulting is an extremely fast-growing staffing and consulting firm. Amerit Consulting was founded in 2002 to provide consulting, temporary staffing, direct hire, and payrolling services to Fortune 500 companies nationally; as well as small to mid-sized organizations on a local & regional level. Currently, Amerit has over 2,000 employees in 47 states. We develop and implement solutions that help our clients operate more efficiently, deliver greater customer satisfaction, and see a positive impact on their bottom line. We create value by bringing together the right people to achieve results. Our clients and employees say they choose to work with Amerit because of how we work with them - with service that exceeds their expectations and a personal commitment to their success. Our deep expertise in human capital management has fueled our expansion into direct hire placements, temporary staffing, contract placements, and additional staffing and consulting services that propel our clients’ businesses forward.

Amerit Consulting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Applicants, with criminal histories, are considered in a manner that is consistent with local, state and federal laws.