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
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