Sterile C&Q Specialist, ALM/CSV Expert

Legal Project Management Partners; Northern (KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Legal Project Management Partners seeks a Commissioning & Qualification (C&Q) Specialist to support a pharmaceutical manufacturing facility in Puerto Rico. You will lead commissioning, qualification, and validation activities for sterile manufacturing areas and systems, including ALM-driven evidence and documentation.

The role requires hands-on C&Q experience, development of IQ/OQ/PQ protocols, and collaboration across Quality, Validation, Engineering, and Manufacturing to meet cGMP and FDA

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, or related projects.
• Hands-on C&Q experience in sterile pharmaceutical manufacturing areas.
• Experience using ALM to develop or execute electronic validation protocols and test scripts and manage 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 FDA-regulated environments.
• Fluency in English and Spanish, spoken and written.
• Strong technical writing, communication, and problem-solving skills.

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, 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.

Skills

C&Q experience

ALM proficiency

Test scripting

Technical writing

Bilingual EN/ES

Education

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

Tools

ALM electronic validation

Job description

Legal Project Management Partners seeks a Commissioning & Qualification (C&Q) Specialist to support a pharmaceutical manufacturing facility in Puerto Rico. You will lead commissioning, qualification, and validation activities for sterile manufacturing areas and systems, including ALM-driven evidence and documentation.

The role requires hands-on C&Q experience, development of IQ/OQ/PQ protocols, and collaboration across Quality, Validation, Engineering, and Manufacturing to meet cGMP and FDA