Computer Software Validation Engineer, GxP Systems

Company: Eidostx
Location: San Francisco
Posted on: September 21, 2023

Job Description:

About Eidos Therapeutics & BridgeBio PharmaEidos Therapeutics, an affiliate of BridgeBio Pharma, is a Phase 3 developmental-stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR. We seek to treat this well-defined family of diseases at their collective source by stabilizing TTR. Our investigational product, acoramidis (AG10), is an orally administered small molecule designed to potently stabilize TTR, a potentially best-in-class treatment aiming to halt the progression of ATTR diseases.BridgeBio is a biopharmaceutical company founded todiscover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseasesand cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.Our focus on scientific excellence and rapid execution aims to translate today's discoveries into tomorrow's medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe.To learn more about our story and company culture, visit us at - Who You AreAs a team member, you will be responsible for partnering with R&D (CMC & Clinical groups) to manage and support enterprise Computer System Validation (CSV) activities.The successful candidate must be an experienced professional with software development life cycle understanding, project management fundamentals, business process analysis skills, and best practice software validation knowledge.This position will work closely with business partners/stakeholders to integrate technology and business processes into effective, efficient, and scalable solutions. The position's success will be measured on enterprise GxP systems, compliance with regulations, and inspection readiness.Responsibilities

• Bachelor's degree in engineering, Information Systems, or equivalent with a combination of education/work experience
• Experience in the life science and cGMP environment
• Experience with Computer System Validation
• Experience with validated environments, change management, and discrepancy reporting
• Solid knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11
• Experience with Veeva Vault (QualityDocs, QMS, Clinical, RIM, Training), DocuSign and SharePoint
• Excellent written and verbal communication skills; quickly producing written, well-organized documentation
• Strong attention to detail
• Proven skills in relationship building, customer focus, decision-making, and problem-solvingNo matter your role at BridgeBio, successful team members are:
  • Patient Champions, who put patients first and uphold strict ethical standards
  • Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
  • Truth Seekers, who are detailed, rational, and humble problem solvers
  • Individuals Who Inspire Excellence in themselves and those around them
  • High-quality executors, who execute against goals and milestones with quality, precision, and speedEducation, Experience & Skills Requirements
    • Bachelor's degree in engineering, Information Systems, or equivalent with a combination of education/work experience
    • Experience in the life science and cGMP environment
    • Experience with Computer System Validation
    • Experience with validated environments, change management, and discrepancy reporting
    • Solid knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11
    • Experience with Veeva Vault (QualityDocs, QMS, Clinical, RIM, Training), DocuSign and SharePoint
    • Excellent written and verbal communication skills; quickly producing written, well-organized documentation
    • Strong attention to detail
    • Proven skills in relationship building, customer focus, decision-making, and problem-solvingWhat We Offer
      • Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
      • A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
      • An unyielding commitment to always putting patients first. Learn more about how we do this
      • A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
      • A place where you own the vision - both for your program and your own career path
      • A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
      • Access to learning and development resources to help you get in the best professional shape of your life
      • Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
      • Flexible PTO
      • Rapid career advancement for strong performers
      • Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time
      • Commitment to Diversity, Equity & Inclusion$95,000 - $145,000 a yearAt BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. The anticipated salary range for candidates for this role who will work in California is $95,000 to $145,000/year. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.To view San Francisco County's Fair Chance Ordinance, please click .
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Keywords: Eidostx, San Francisco , Computer Software Validation Engineer, GxP Systems, IT / Software / Systems , San Francisco, California