Senior CSV Specialist

🔥 3 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 12%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Just posted.
• No salary listed.

Apply Now

Check your resume score

Customize resume + cover letter

Find Similar Remote Jobs

☆ Save☑️ Mark as applied❌ Hide

Report problem

Pinnaql

WebsiteLinkedInAll Job Openings

201 - 500 employees

💊 Pharmaceuticals

🧬 Biotechnology

Pharmaceuticals • Biotechnology

Pinnaql is a life‑sciences technical and compliance services firm. It partners with pharmaceutical, biotechnology, radiopharma, cell & gene therapy (CGT), medical device companies, CDMOs and compounding pharmacies to deliver quality systems, lab and manufacturing technical operations, validation (CQV/CSV), automation and digital transformation, and engineering/project management support. Core services include QMS development and eQMS, regulatory and audit support, SOP/CAPA/deviation management, computer system validation and 21 CFR Part 11 compliance, LIMS and data integrity support, equipment and analytical method validation, commissioning/qualification/validation, process and cleaning validation, and automation/robotics integration. Pinnaql's experts embed with client teams to improve compliance, accelerate timelines, optimize manufacturing readiness and support tech transfer from development to commercialization. Offices are listed in Malvern, PA and Indianapolis, IN.

📋 Description

• Provide computerized system validation and data integrity expertise for regulated life sciences clients • Support laboratory, sterile, and non-sterile pharmaceutical manufacturing operations • Participate in the design, planning, implementation, and follow-up of quality computerized systems projects and/or Enterprise IT Solutions • Visit laboratory areas during qualification and validation studies • Apply cGMP, FDA, Data Integrity, and 21 CFR Part 11 requirements • Manage projects and influence internal teams and business areas to deliver results • Work rotating shifts, irregular hours, weekends, and holidays as operational needs require • Travel 10% to 15% for project-related activities

🎯 Requirements

• Bachelor’s Degree in Science (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 project management skills • Ability to impact and influence people and areas within the company to deliver superior business results • Excellent oral, written, and reading communication skills in Spanish and English • Willingness to travel 10% to 15% • Availability to work rotating shifts, irregular hours, weekends, and holidays depending on operational needs • Ability to work in normal office and laboratory environments, including potential exposure to toxic materials

🏖️ Benefits

• Equal opportunity employment • Supportive, purpose-driven team environment • Opportunity to make a meaningful difference in healthcare and technology • Exposure to diverse project work across pharmaceutical, biotech, and medical device organizations

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume