Onsite GMP C&Q Specialist: Field Validation & Testing

Inteldot; Gurabo (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

Inteldot seeks a C&Q Specialist to oversee commissioning and qualification activities for capital projects in a pharmaceutical manufacturing environment in Puerto Rico. The successful candidate will ensure compliance with GMP and regulatory requirements.

The role involves developing and executing protocols, supporting equipment testing, and ensuring data integrity. Applicants should possess a relevant Bachelor’s degree and experience in C&Q processes.

Qualifications

• Minimum 2 years of experience in commissioning and qualification for science or engineering degree.
• Minimum 3 years of experience in commissioning and qualification processes for business administration degree.
• Experience in regulated pharmaceutical or biotechnology environment.

Responsibilities

• Develop C&Q protocols and documentation according to industry standards.
• Execute C&Q activities in manufacturing, packaging, and facility systems.
• Support and participate in FAT and SAT for new equipment.

Skills

C&Q protocols development

GMP compliance

Data integrity principles (ALCOA+)

Bilingual (Spanish and English)

Education

Bachelor’s degree in science or engineering

Bachelor’s degree in business administration

Job description

Inteldot seeks a C&Q Specialist to oversee commissioning and qualification activities for capital projects in a pharmaceutical manufacturing environment in Puerto Rico. The successful candidate will ensure compliance with GMP and regulatory requirements.

The role involves developing and executing protocols, supporting equipment testing, and ensuring data integrity. Applicants should possess a relevant Bachelor’s degree and experience in C&Q processes.