C&Q Engineer Specialist

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

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 youre empowered to do your best work bold ideas thrive and real progress happens. This isnt just a job - its 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.