Pinnaql
1 day ago Be among the first 25 applicants
Direct message the job poster from Pinnaql
Pinnaql
is a consulting partner to regulated life sciences companies—bringing deep technical, validation, and quality expertise to every stage of the product lifecycle. We help pharmaceutical, biotech, and medical device organizations overcome complexity, accelerate timelines, and stay audit-ready. 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 your opportunity to make a meaningful difference. You’ll help shape the future of healthcare and technology, working alongside a purpose-driven team that’s as ambitious as it is supportive. We’re committed to your well-being, growth, and future. That’s why we offer a comprehensive benefits package including medical, dental, vision coverage and a 401(k) with company match. Add to that generous time off, flexible work options and professional development support. You're set up to thrive both at work and at home. We are currently seeking to identify
Computer System Validation (CSV) Engineers
with cGMP experience for both immediate and future consulting project needs. This is a pipeline opportunity to support our ongoing client engagements. Qualified applicants will be contacted as relevant projects arise. Excited to build something meaningful together? We look forward to hearing from you. Candidates may reside anywhere in the United States but must be authorized to work for any U.S. employer without the need for visa sponsorship. Qualifications Bachelor's degree in computer science, engineering, life sciences, or a related technical field Experience validating GxP systems in pharma, biotech, or medical device environments Working knowledge of 21 CFR Part 11, Annex 11, GAMP 5, and other relevant FDA/ICH guidance Hands-on experience authoring and executing validation deliverables including risk assessments, validation plans, IQ/OQ/PQ protocols, and traceability matrices Experience with systems such as LIMS, ERP, MES, QMS, PLC/SCADA, or laboratory instrumentation software is preferred Understanding of data integrity principles, audit trails, and ALCOA+ Strong documentation and technical writing skills Excellent communication skills and ability to collaborate cross-functionally Responsibilities Responsibilities will vary depending on the project and client needs. Typical responsibilities may include: Authoring, reviewing, and executing validation deliverables for GxP computer systems Performing risk assessments and ensuring validation approaches meet regulatory and client requirements Supporting implementation and lifecycle management of validated systems Ensuring compliance with 21 CFR Part 11, GAMP 5, and data integrity best practices Collaborating with Quality, IT, and Business users to ensure requirements are met and appropriately tested Supporting audit readiness and remediation activities related to system validation Providing guidance on software change controls, configuration management, and system documentation Work Requirements This is a U.S.-based consulting role requiring 25-75% travel, depending on project location and client assignment Flexibility for on-site client work is essential 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. Seniority level
Seniority level Entry level Employment type
Employment type Other Job function
Job function Other Industries IT Services and IT Consulting Referrals increase your chances of interviewing at Pinnaql by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Disability insurance Get notified about new Engineer jobs in
Indiana, United States . Indianapolis, IN $88,334.00-$136,477.00 6 days ago Indianapolis, IN $35.00-$45.00 3 weeks ago Butler, IN $80,000.00-$126,500.00 9 hours ago Emirates Airways Aircraft Technician Careers (Apply Now)
Indianapolis, IN $90,985.00-$136,477.00 6 days ago Manufacturing Engineer – Measurement Specialist
Indianapolis, IN $90,985.00-$136,477.00 1 week ago Indianapolis, IN $80,000.00-$87,000.00 1 month ago Rushville, IN $65,000.00-$95,000.00 1 day ago Advanced Manufacturing Engineer - Program Lead
Indianapolis, IN $64,500.00-$167,200.00 1 week ago Indianapolis, IN $100,000.00-$110,000.00 2 weeks ago Greater Indianapolis $80,000.00-$90,000.00 1 week ago Lafayette, IN $80,000.00-$90,000.00 1 week ago Riyadh Air Vacancies Aircraft Mechanic (Apply Now)
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
is a consulting partner to regulated life sciences companies—bringing deep technical, validation, and quality expertise to every stage of the product lifecycle. We help pharmaceutical, biotech, and medical device organizations overcome complexity, accelerate timelines, and stay audit-ready. 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 your opportunity to make a meaningful difference. You’ll help shape the future of healthcare and technology, working alongside a purpose-driven team that’s as ambitious as it is supportive. We’re committed to your well-being, growth, and future. That’s why we offer a comprehensive benefits package including medical, dental, vision coverage and a 401(k) with company match. Add to that generous time off, flexible work options and professional development support. You're set up to thrive both at work and at home. We are currently seeking to identify
Computer System Validation (CSV) Engineers
with cGMP experience for both immediate and future consulting project needs. This is a pipeline opportunity to support our ongoing client engagements. Qualified applicants will be contacted as relevant projects arise. Excited to build something meaningful together? We look forward to hearing from you. Candidates may reside anywhere in the United States but must be authorized to work for any U.S. employer without the need for visa sponsorship. Qualifications Bachelor's degree in computer science, engineering, life sciences, or a related technical field Experience validating GxP systems in pharma, biotech, or medical device environments Working knowledge of 21 CFR Part 11, Annex 11, GAMP 5, and other relevant FDA/ICH guidance Hands-on experience authoring and executing validation deliverables including risk assessments, validation plans, IQ/OQ/PQ protocols, and traceability matrices Experience with systems such as LIMS, ERP, MES, QMS, PLC/SCADA, or laboratory instrumentation software is preferred Understanding of data integrity principles, audit trails, and ALCOA+ Strong documentation and technical writing skills Excellent communication skills and ability to collaborate cross-functionally Responsibilities Responsibilities will vary depending on the project and client needs. Typical responsibilities may include: Authoring, reviewing, and executing validation deliverables for GxP computer systems Performing risk assessments and ensuring validation approaches meet regulatory and client requirements Supporting implementation and lifecycle management of validated systems Ensuring compliance with 21 CFR Part 11, GAMP 5, and data integrity best practices Collaborating with Quality, IT, and Business users to ensure requirements are met and appropriately tested Supporting audit readiness and remediation activities related to system validation Providing guidance on software change controls, configuration management, and system documentation Work Requirements This is a U.S.-based consulting role requiring 25-75% travel, depending on project location and client assignment Flexibility for on-site client work is essential 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. Seniority level
Seniority level Entry level Employment type
Employment type Other Job function
Job function Other Industries IT Services and IT Consulting Referrals increase your chances of interviewing at Pinnaql by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Disability insurance Get notified about new Engineer jobs in
Indiana, United States . Indianapolis, IN $88,334.00-$136,477.00 6 days ago Indianapolis, IN $35.00-$45.00 3 weeks ago Butler, IN $80,000.00-$126,500.00 9 hours ago Emirates Airways Aircraft Technician Careers (Apply Now)
Indianapolis, IN $90,985.00-$136,477.00 6 days ago Manufacturing Engineer – Measurement Specialist
Indianapolis, IN $90,985.00-$136,477.00 1 week ago Indianapolis, IN $80,000.00-$87,000.00 1 month ago Rushville, IN $65,000.00-$95,000.00 1 day ago Advanced Manufacturing Engineer - Program Lead
Indianapolis, IN $64,500.00-$167,200.00 1 week ago Indianapolis, IN $100,000.00-$110,000.00 2 weeks ago Greater Indianapolis $80,000.00-$90,000.00 1 week ago Lafayette, IN $80,000.00-$90,000.00 1 week ago Riyadh Air Vacancies Aircraft Mechanic (Apply Now)
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr