C&Q Specialist | Manatí, PR | On-Site

Legalpmpartners; Gurabo (PR); On-site; USD 90,000 - 125,000; Full time

Job summary

Legalpmpartners seeks a Commissioning & Qualification (C&Q) Specialist to support a pharmaceutical manufacturing facility in Manatí, Puerto Rico. The role requires hands-on C&Q in sterile areas and proficiency with ALM for electronic validation protocols and testing.

You will support commissioning, qualification, validation, startup, and operational readiness activities for equipment, utilities, facilities, and computerized systems, ensuring cGMP and FDA compliance, with English and Spanish

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Computer Science, IT, or related field.
• 5+ years of pharmaceutical commissioning, qualification, validation, or related projects.

Responsibilities

• Develop, review, and execute commissioning and IQ/OQ/PQ protocols for sterile manufacturing areas and systems.
• Support C&Q activities involving autoclaves, clean utilities, HVAC, BAS.
• Develop and execute electronic protocols and test scripts in ALM with traceability.

Skills

C&Q experience

Technical writing

Communication

Problem solving

Bilingual English/Spanish

Education

Bachelor's degree in Engineering, Life Sciences, Computer Science, IT or related

Tools

ALM electronic validation

Job description

Position Summary

We are seeking a Commissioning & Qualification (C&Q) Specialist to support a pharmaceutical manufacturing facility in Manatí, Puerto Rico. Strong hands‑on experience in C&Q of sterile manufacturing areas and proficiency with the ALM electronic validation system are essential for this role.

The specialist will support commissioning, qualification, validation, startup, and operational readiness activities for pharmaceutical equipment, utilities, facilities, computerized systems, and manufacturing areas.

Key Responsibilities

Develop, review, and execute commissioning and IQ/OQ/PQ protocols for sterile manufacturing areas, pharmaceutical equipment, utilities, facilities, and manufacturing systems.

Support C&Q activities involving autoclaves, clean utilities, HVAC, Building Automation Systems (BAS), and other systems used in sterile manufacturing.

Develop and execute electronic protocols and test scripts in ALM, maintaining accurate test evidence, traceability, deviations, and documentation.

Support construction turnover, startup, qualification readiness, and operational readiness.

Support Computerized System Validation (CSV) activities, including requirements, risk assessments, testing, and traceability.

Prepare protocols, reports, test records, SOPs, and qualification packages in compliance with cGMP, FDA requirements, and company procedures.

Support change controls, investigations, deviations, CAPA, system upgrades, requalification, and decommissioning.

Collaborate with Quality, Validation, Engineering, Automation, Manufacturing, Facilities, Construction, CSV, and vendors.

Required Qualifications

Bachelor’s degree in Engineering, Life Sciences, Computer Science, Information Technology, or a related field.

At least 5 years of experience in pharmaceutical commissioning, qualification, validation, facilities/utilities, engineering support, or related projects.

Strong, hands‑on C&Q experience in sterile pharmaceutical manufacturing areas.

Hands‑on experience using ALM to develop or execute electronic validation protocols and test scripts and manage associated documentation.

Experience developing, reviewing, and executing commissioning and IQ/OQ/PQ protocols.

Experience with pharmaceutical systems such as autoclaves, clean utilities, HVAC, and BAS.

Strong knowledge of cGMP and experience in FDA‑regulated environments.

Fluency in English and Spanish, spoken and written.

Strong technical writing, communication, and problem‑solving skills.