Senior CSV Specialist

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.

At Pinnaql, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

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.