Overview
Commissioning & Qualification (C&Q) Executer Jobs in Juncos, PR at High Performance Consulting Services, Corp.
Overview
High Performance Consulting Services Corporation is seeking a highly technical Commissioning & Qualification (C&Q) Executer to support engineering, commissioning, and qualification activities for GMP‑regulated systems within pharmaceutical and biotechnology manufacturing environments. The resource will execute protocol-driven testing, equipment qualification, and system verification aligned with FDA, EMA, and industry CQV standards.
Technical Responsibilities
- Execute IQ/OQ/PQ protocols for equipment, utilities, automation systems, and manufacturing assets.
- Perform commissioning activities including functional testing, SAT/FAT support, and system readiness verification.
- Generate and maintain GMP-compliant documentation, including test scripts, data packages, traceability matrices, and qualification reports.
- Identify, document, and support resolution of deviations, non-conformances, and discrepancies encountered during execution.
- Interface with Engineering, Automation, Quality Assurance, and Validation teams to ensure alignment with project deliverables and regulatory expectations.
- Apply risk-based CQV methodologies (ASTM E2500, ISPE Baseline Guides) to commissioning and qualification activities.
- Ensure all work complies with 21 CFR Part 11, Part 210/211, EU Annex 15, and internal quality systems.
- Support change control, impact assessments, and system release processes as required.
Required Qualifications
- Bachelor’s degree in Engineering, Life Sciences, or related technical discipline.
- 3–5 years of hands-on experience in Commissioning & Qualification, CQV, or Equipment Validation within GMP environments.
- Strong understanding of GMP regulations, data integrity principles, and qualification lifecycle documentation.
- Experience with manufacturing equipment, clean utilities, HVAC, automation systems, or process equipment preferred.
- Ability to interpret P&IDs, URS, FRS, design specifications, and vendor documentation.
- Proficiency in technical writing and documentation control.
- Strong analytical, troubleshooting, and problem-solving skills.
Contract Details
- Type: Professional services / contract.
- Location: Puerto Rico (client site: Juncos).
- Compensation: Based on experience and technical capability.
About High Performance Consulting Services Corp.
High Performance Consulting Services Corporation provides specialized engineering, validation, quality, and technical resources to regulated industries across Puerto Rico. We support complex projects in pharmaceutical manufacturing, biotechnology, medical devices, and industrial operations, delivering high-performance talent aligned with strict regulatory and operational requirements.
How to Apply
Submit your resume to [email protected]
or apply directly through Indeed.
Pay: $45.00 – $55.00 per hour
Work Location: In person
Title: Commissioning & Qualification (C&Q) Executer
Company: High Performance Consulting Services, Corp.
Location: Juncos, PR
Category:
