CSV Support Resource – MES Validation

Weil Group, Inc; United States; On-site; USD 90,000 - 110,000; Full time

Job summary

Weil Group, Inc. seeks a qualified professional for Computer Systems Validation in a pharmaceutical setting. A bachelor’s degree in Engineering, Computer Systems, or Life Sciences with at least three years of CSV experience is required, along with the ability to read drawings and technical documents.

You will collaborate with internal and external customers, apply AI tools, ensure compliance with cGMP and regulatory procedures, and communicate effectively in English and Spanish.

Qualifications

• Bachelor’s degree in Engineering, Computer Systems or Life Sciences with at least 3 years CSV experience in a pharma environment.
• Ability to read and interpret drawings, design specifications and other technical documents.
• Capable of using computers and software packages, and leveraging AI tools.
• Knowledge of cGMPs and regulatory documentation for pharmaceutical manufacturing.
• Bilingual English/Spanish, both written and verbal.
• Ability to interact and maintain relationships with internal and external customers at all levels.
• Ability to plan and prioritize multiple activities under schedule pressure.
• Effective written and oral communication skills.
• Customer service oriented and a self-starter.
• Good judgment under tight deadlines.

Skills

Bachelor’s degree, Engineering/CS/Life

CSV experience (pharma)

Reading drawings & specs

AI tools usage

cGMP & regulatory knowledge

Bilingual English/Spanish

Interpersonal skills

Project prioritization

Written & verbal communication

Customer service mindset

Judgment under pressure

Education

Bachelor’s degree in Engineering, Computer Systems or Life Sciences

Tools

AI tools

Job description

The resources for this opportunity must meet the following minimum requirements in order to be considered:

Qualifications and Required Knowledge/Skills

• Bachelor’s degree in Engineering, Computer Systems or Life Sciences, combined with aminimum of three (3) years of Computer Systems Validation (CSV) working experience.Experience must be within a pharmaceutical environment, developing CSV assessments and testing protocols.
• Capable of reading and interpreting drawings, design specifications and any othertechnical document.
• Capable of understanding and using computers and software packages, and ofleveraging Artificial Intelligence (AI) tools.
• Knowledge of cGMPs, local/federal regulatory requirements and documentationprocedures pertaining to a pharmaceutical manufacturing plant.
• Bilingual English/Spanish, both written and verbal, is required.
• Able to interact effectively with people to establish and maintain excellent workingrelationships with internal and external customers at all organizational levels anddisciplines.
• Able to plan and prioritize multiple activities simultaneously.
• Effective written and oral communication skills.
• Customer service oriented and a self-starter.
• Ability to exercise good judgment and work under schedule-commitment pressure.

Weil Group is proud to be an Equal Employment Opportunity Employer.