C&Q Engineer / Specialist

Veg Group; Cayey (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking a Validation Specialist/Engineer with hands-on experience in pharmaceutical equipment and utilities qualification.

The role focuses on developing and amending validation protocols, executing FAT/IQ/PQ activities, and delivering inspection-ready documentation. Candidates should have a BS in a related field, about 5 years of validation experience, and knowledge of GMP, CAPA, and regulatory expectations.

Qualifications

• BS in Engineering, Chemistry, Biology or related field.
• 5 years (±2) experience in validation of pharmaceutical equipment and utilities.
• Experience with FAT, IQ/OQ, and PQ execution; PQ for water systems preferred.
• Knowledge of GMP, validation lifecycle, protocol/report writing, and CAPA processes.
• Proficient with technical documentation tools and on-site work.

Responsibilities

• Review and amend validation protocols across equipment and utility systems.
• Plan and execute FAT (Factory Acceptance Test) activities and IQ for equipment.
• Plan and execute PQ (Performance Qualification) for DI water generation and distribution.
• Produce updated protocols, test scripts, execution records and final validation reports with deviations.

Skills

Validation experience

GMP knowledge

CAPA processes

Documentation

Stakeholder coordination

Communication skills

Bilingual English/Spanish

Education

BS in Engineering, Chemistry, Biology

Tools

MS Word

MS Excel

Job description

Current job opportunities are posted here as they become available.

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Validation Specialist/Engineer with approximate 5 years’ hands‑on experience in pharmaceutical/biotech equipment and utilities qualification. Demonstrated background in developing and amending validation protocols, executing FATs, IQ/OQ activities, and performing PQ for water systems (DI/PW/WFI).
Strong understanding of GMP, quality systems (QMS), CAPA, and regulatory expectations; capable of coordinating with operations and engineering, executing on‑site testing, and delivering inspection‑ready documentation.

Combined scope & deliverables:

• Review and prepare amendments to existing validation protocols across equipment and utility systems.
• Plan and execute FAT (Factory Acceptance Test) activities and prepare/perform IQ (Installation Qualification) for equipment.
• Plan and execute PQ (Performance Qualification) for DI water (deionized water) generation and distribution system, test execution, data analysis, and acceptance criteria.
• Produce updated protocols (amendments), test scripts/checklists, FAT/IQ/PQ execution records, final validation reports with deviations logged, root‑cause notes and recommendations for corrective actions where applicable.

Suggested qualifications:

• BS in Engineering, Chemistry, Biology, or related field.
• 5 years (±2) experience in validation of pharmaceutical equipment and utilities, highly preferable in Medical Device Industry.
• Specific experience with FAT, IQ/OQ, and PQ execution; demonstrated PQ experience for water systems (DI/PW/WFI) preferred.
• Knowledgeable in GMP, validation lifecycle, protocol/report writing, and CAPA processes.
• Proficient with technical documentation tools (MS Word/Excel), and comfortable working on‑site as required.
• Strong communication skills for stakeholder coordination and delivering inspection‑ready documentation.
• Certifications: ASQ, PDA.
• Language: English and Spanish

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.

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.