CSV Support Resource - MES Validation

Weil Group, Inc.; San Juan (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

Weil Group, Inc. is seeking a CSV professional to support pharmaceutical validation activities.

The role requires a degree in Engineering/Computer Systems/Life Sciences and at least three years of CSV experience in a pharmaceutical environment, including developing CSV assessments and testing protocols. The candidate should be able to read drawings and specifications, use AI tools, and navigate regulatory requirements (cGMP) while communicating effectively in English and Spanish with

Qualifications

• Bachelor's degree in Engineering, Computer Systems or Life Sciences with 3+ years CSV experience in pharma
• Ability to read and interpret drawings, design specs and technical documents
• Ability to understand and use computers and software packages, and leverage AI tools
• Knowledge of cGMPs and regulatory documentation for pharma manufacturing
• Bilingual English/Spanish, both written and verbal
• Able to interact with internal/external stakeholders at all levels
• Able to plan and prioritize multiple activities
• Effective written and oral communication
• Customer service oriented and a self-starter
• Ability to work under schedule-commitment pressure

Skills

CSV experience

Pharmaceutical environment

Reading drawings and specs

AI tools usage

Communication skills

Multitasking

Self-starter

Schedule pressure management

Education

Bachelor's degree in Engineering/Computer Systems/Life Sciences

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 a minimum 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 other technical document.
• Capable of understanding and using computers and software packages, and of leveraging Artificial Intelligence (AI) tools.
• Knowledge of cGMPs, local/federal regulatory requirements and documentation procedures 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 working relationships with internal and external customers at all organizational levels and disciplines.
• 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.