Senior CSV Specialist: Data Integrity & Regulatory Compliance

Pinnaql; United States; Remote; USD 110,000 - 150,000; Full time

Job summary

Pinnaql is seeking a talented, dedicated individual for a Senior CSV Specialist (Back-Fill) – RFP position. The candidate will apply expertise in computerized system validation, FDA cGMP compliance, and Data Integrity across pharmaceutical operations, collaborating with diverse teams in a regulated environment.

The role requires strong project management, excellent bilingual communication, and the ability to influence multiple stakeholders to ensure audit readiness and quality assurance

Qualifications

• Bachelor’s degree in science required; Computer Systems or Engineering preferred.
• Thorough knowledge of cGMP, FDA and Data Integrity regulations.
• Experience with computerized system validation methodologies, 21 CFR Part 11, and Data Integrity regulations.
• Minimum of four (4) years of computerized system validation and data integrity experience within pharmaceutical manufacturing operations.
• Proven experience supporting laboratory, sterile and non-sterile operations.
• Proven skills in project management.
• Ability to impact and influence people and areas within the company to deliver superior business results.
• Excellent communication skills (oral, written and reading) in Spanish and English.

Skills

cGMP knowledge

Data Integrity

CSV methodologies

Project management

Bilingual English/Spanish

Communication skills

Influencing skills

Education

Bachelor’s Degree in Science (Computer Systems or Engineering preferred)

Job description

Pinnaql is seeking a talented, dedicated individual for a Senior CSV Specialist (Back-Fill) – RFP position. The candidate will apply expertise in computerized system validation, FDA cGMP compliance, and Data Integrity across pharmaceutical operations, collaborating with diverse teams in a regulated environment.

The role requires strong project management, excellent bilingual communication, and the ability to influence multiple stakeholders to ensure audit readiness and quality assurance