CQV Specialist Utilities

CQV Specialist Utilities

Supports commissioning, qualification, validation, and maintenance programs in GMP-regulated facilities. Performs activities in accordance with regulatory requirements and industry best practices while working effectively in a multidisciplinary project environment. Experience with non-critical utilities and system validation activities is considered a strong asset.

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.

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 and considered a strong asset for these roles.
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• Must be proficient using 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.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team. Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.