C&Q Engineer / Specialist

Pinnaql; Cayey (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Validation & Engineering Group Inc, a Pinnaql company, seeks a Validation Specialist/Engineer with hands-on pharma/biotech equipment and utilities qualification experience. The role focuses on on-site testing, protocol development, and delivering inspection-ready documentation.

Expect coordination with operations and engineering teams. Responsibilities include FAT, IQ, and PQ execution for water systems; developing amendments to protocols and final reports with deviations and CAPA notes.

Qualifications

• Hands-on validation experience in pharma/biotech equipment and utilities.
• Strong understanding of GMP and quality systems (QMS, CAPA).
• Experience with FAT/IQOQ/PQ execution and on-site testing.

Responsibilities

• Review and amend existing validation protocols for equipment and utilities.
• Plan and execute FAT, IQ, and PQ activities; generate documentation.
• Prepare final validation reports with deviations, root cause analysis and CAPA recommendations.
• Coordinate with operations and engineering to deliver inspection-ready files on site.

Skills

Validation

FAT

IQOQ

PQ

Documentation

Education

BS in Engineering/Chemistry/Biology

Tools

MS Word

Excel

Job description

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 SpecialistEngineerValidation SpecialistEngineer with approximate 5 years hands on experience in pharmaceuticalbiotech equipment and utilities qualification

Demonstrated background in developing and amending validation protocols executing FATs IQOQ activities and performing PQ for water systems DIPWWFI 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 prepareperform 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 scriptschecklists FATIQPQ 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 IQOQ and PQ execution; demonstrated PQ experience for water systems DIPWWFI preferred Knowledgeable in GMP validation lifecycle protocolreport writing and CAPA processes Proficient with technical documentation tools MS WordExcel 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