CQV Engineer: GMP Validation & Commissioning

myhrabc; Cidra (PR); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, and vision

Adoption assistance

Infertility coverage

Paid parental leave

Training & development

Mentorship programs

Job summary

Cencora is seeking Commissioning, Qualification, and Validation (CQV) professionals to support validation activities in regulated pharmaceutical, biotechnology, or medical device environments. This role welcomes Engineers, Scientists, and Validation Specialists with experience supporting equipment, utilities, laboratory systems, or facilities qualification.

The selected consultant will develop, execute, and document IQ/OQ/PQ activities, ensuring cGMP compliance. Location: Cidra, PR.

Qualifications

• Experience supporting IQ/OQ/PQ execution or validation documentation.
• Knowledge of cGMP regulations and validation lifecycle.
• Strong technical writing and documentation skills.

Responsibilities

• Support Commissioning, Qualification, and Validation (CQV) activities.
• Develop, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Assist with equipment startup and commissioning activities.
• Author and review validation documentation, including protocols, reports, and discrepancy resolutions.
• Ensure compliance with cGMP regulations, FDA guidelines, and internal quality systems.
• Participate in risk assessments and impact assessments related to validation activities.
• Support change control, deviations, and CAPA investigations when required.
• Collaborate with Engineering, Quality, Laboratory, Manufacturing, and Validation teams.
• Ensure compliance with Good Documentation Practices (GDP) and data integrity principles.

Skills

CQV experience

Technical writing

Regulated manufacturing

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Chemistry, Microbiology, Biology, or related field

Tools

IQ/OQ/PQ protocols

cGMP knowledge

Job description

Cencora is seeking Commissioning, Qualification, and Validation (CQV) professionals to support validation activities in regulated pharmaceutical, biotechnology, or medical device environments. This role welcomes Engineers, Scientists, and Validation Specialists with experience supporting equipment, utilities, laboratory systems, or facilities qualification.

The selected consultant will develop, execute, and document IQ/OQ/PQ activities, ensuring cGMP compliance. Location: Cidra, PR.