Senior CSV Specialist

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 a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position

Qualifications

Qualifications and Required Knowledge/Skills

• Bachelor’s Degree in Science (Computer Systems or Engineering preferred).
• Thorough knowledge of cGMP, FDA and Data Integrity regulations is a must.
• 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. Senior CSV Specialist (Back-Fill) – RFP Position Description | Page 3 BMS Confidential
• 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.

Working Conditions

Work Environment: Normal office environment and laboratory working environment. The role may involve exposure to potentially toxic materials used in analysis, due to the need to visit laboratory areas during qualification and validation studies. Travel: 10% to 15%, to participate in the design, planning, implementation and follow-up of quality computerized systems projects and/or Enterprise IT Solutions.

Shifts: Must be available to work rotating shifts, irregular hours, weekends and holidays, depending on operational needs.

Pinnaql is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.