Sterile Pharma C&Q Specialist: ALM & CSV Expert

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

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