Bilingual CQV Specialist - Utilities & Validation

Veg Group; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG) is seeking a CQV Specialist Utilities to support commissioning, qualification, validation, and maintenance programs in GMP facilities. The ideal candidate has hands-on experience and strong cGxP knowledge.

The role requires bilingual English/Spanish, proficiency with MS Windows and Microsoft Office, and willingness to work extended hours, including weekends and holidays.

Qualifications

• Hands-on experience in commissioning, qualification, validation, and/or maintenance programs.
• Familiarity with regulatory requirements and industry best practices.
• Ability to work effectively in a multidisciplinary project environment.
• Experience with non-critical utilities and system validation activities is highly appreciated.
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• Proficient with MS Windows and Microsoft Office applications.
• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
• Strong experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.
• Technical writing skills and investigations processes.
• Available to work extended hours, possibility of weekends and holidays.

Responsibilities

• Support commissioning, qualification, validation, and maintenance programs.
• Work in accordance with regulatory requirements and industry best practices.
• Work effectively in a multidisciplinary project environment.

Skills

Bilingual English/Spanish

Regulatory compliance knowledge

Technical writing

Multidisciplinary teamwork

Tools

MS Windows

Microsoft Office

Job description

Validation & Engineering Group, Inc. (V&EG) is seeking a CQV Specialist Utilities to support commissioning, qualification, validation, and maintenance programs in GMP facilities. The ideal candidate has hands-on experience and strong cGxP knowledge.

The role requires bilingual English/Spanish, proficiency with MS Windows and Microsoft Office, and willingness to work extended hours, including weekends and holidays.