Computer System Validation Associate - CSV
About the job
- A bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, or a related discipline.
- At least 2 years of experience in Computer System Validation, Quality Systems, or IT compliance within a regulated environment.
- Working knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, Data Integrity principles including ALCOA+, Change Management, and Software Development Life Cycle methodologies.
- Experience developing and executing validation documentation and test protocols.
- Familiarity with laboratory and manufacturing systems such as Laboratory Information Management Systems, Quality Management Systems, Manufacturing Execution Systems, Veeva Vault, TrackWise, analytical instruments, and standalone systems.
- Familiarity with audit trail review, electronic signatures, and security and access management.
- Strong technical writing, documentation, and communication skills.
- Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment.
- Ability to work independently and collaboratively within cross-functional teams.
- Support Computer System Validation activities for GxP computerized systems, analytical instruments, laboratory systems, manufacturing systems, and software applications.
- Develop, review, execute, and maintain validation documentation, including Validation Plans, User Requirements Specifications, Functional and Design Specifications, Risk Assessments, Installation/Operational/Performance Qualification Protocols, Traceability Matrices, and Validation Summary Reports.
- Support system implementations, upgrades, configuration changes, and periodic reviews in accordance with established procedures.
- Ensure computerized systems remain in a validated and compliant state throughout the system lifecycle.
- Support compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and Data Integrity requirements.
- Author, revise, and review standard operating procedures, work instructions, forms, and policies related to Computer System Validation, IT compliance, data integrity, and computerized systems.
- Collaborate with Quality Assurance, Quality Control, Manufacturing, Information Technology, Engineering, Regulatory Affairs, Research and Development, Supply Chain, and vendors to support project execution and compliance activities.
- Participate in discrepancy investigations, Corrective and Preventive Actions, deviations, and change control assessments related to computerized systems.
- Support audit and inspection readiness activities and assist during internal and external audits.
- Perform and document periodic reviews of computerized systems according to established procedures.
- Assist with user access reviews, backup verification activities, and system administration support as applicable.
- Support vendor assessments and leverage vendor documentation packages where appropriate.
- Maintain validation documentation and records within electronic document management systems such as Veeva Vault.
- Support data migration, disaster recovery, and system retirement activities as needed.
- Perform additional duties as assigned.
- Experience supporting computerized systems in pharmaceutical, biotechnology, medical device, or other regulated industries.
- Knowledge of IT infrastructure concepts, including backups, disaster recovery, Active Directory, networking, cybersecurity, and system security.
- Experience supporting cloud-based or Software as a Service applications in regulated environments.
About the company
Krystal Biotech develops and sells gene therapies for rare dermatological diseases. Its lead product, VYJUVEK (beremagene geperpavec-svdt), is a topical gene therapy designed to treat dystrophic epidermolysis bullosa (DEB) by delivering a corrected gene directly to the skin so that damaged skin can heal. The company’s STAR-D platform enables off-the-shelf gene therapies that can be used across a range of skin conditions and the VYJUVEK therapy is designed to be redoable, meaning its treatment can be repeated if needed. Krystal Biotech stands out by owning exclusive worldwide rights to its therapies and by being the first FDA-approved medicine for DEB, a rare condition. The company’s goal is to grow its portfolio of dermatology gene therapies using the STAR-D platform to provide accessible, repeatable treatments for patients with rare skin diseases.
Company Size
201-500
Company Stage
IPO
Headquarters
Pittsburgh, Pennsylvania
Founded
2016
Get referred to Krystal Biotech
See people who can refer or advise you
Simplify's Take
What believers are saying
- Q2 2026 VYJUVEK revenue hit $119.2M, up 24%, with 95% gross margin.
- UK approval in May 2026 and Spain-Italy launches target late 2026 expansion.
- KB803 readout is slated for 4Q 2026 after full enrollment in April.
What critics are saying
- Germany pricing negotiations run through 2H 2026, and France extends into 2027.
- Forman filed patent inventorship suit on May 29, 2026 over KB407-related CFTR patents.
- VYJUVEK concentration creates existential risk if DEB pricing access stalls or new ocular programs fail.
What makes Krystal Biotech unique
- VYJUVEK is first redosable gene therapy and first DEB medicine approved by FDA, EMA, MHRA.
- STAR-D delivers off-the-shelf topical skin gene therapy, avoiding patient-specific manufacturing.
- Krystal uses flexible home-or-clinic dosing, strengthening adherence in chronic wound care.
Help us improve and share your feedback! Did you find this helpful?
Growth & Insights and Company News
6 month growth
↑ 0%1 year growth
↑ 0%2 year growth
↑ 1%Krystal Biotech reported second-quarter 2026 revenue of $119.2 million from global sales of VYJUVEK, up 24% year over year. US sales reached $91.6 million, whilst net income rose to $54.8 million, or $1.79 per diluted share, from $38.3 million a year earlier. The company ended the quarter with over $1.1 billion in cash and investments. It has secured more than 730 US reimbursement approvals and is expanding outreach to community settings to reach potentially undiagnosed patients. European and Japanese revenue growth was constrained by a German pricing reserve, with negotiations expected to conclude in the third quarter. The company maintained its full-year 2026 expense outlook of $175 million to $195 million. Multiple pipeline milestones are approaching, including results from the IOLITE study of KB803 expected later this year.
Krystal Biotech reported second-quarter 2026 earnings that beat expectations but missed on revenue, sending shares down 7.65% in pre-market trading. The company posted adjusted earnings of $1.79 per share, exceeding the $1.70 consensus estimate. Product revenue reached $119.2 million, below the $122.3 million forecast, though up 24% from $96 million a year earlier. Net income rose to $54.8 million from $38.3 million in the prior-year quarter. The company reported a 95% gross margin for VYJUVEK, its flagship product, which secured over 730 reimbursement approvals and is prescribed by more than 640 healthcare providers. Krystal ended the quarter with approximately $1.1 billion in cash and investments. Commercial launches in Italy and Spain are expected before year-end.
Krystal Biotech reported $119.2 million in global VYJUVEK revenue for the second quarter of 2026, a 24% increase year-over-year. The gene therapy for dystrophic epidermolysis bullosa has generated $965.9 million since launch, with a gross margin of 95%. The company has secured over 730 reimbursement approvals in the United States and expanded to more than 640 prescribers. VYJUVEK continues gaining traction in Germany, France, and Japan, with launches planned in Spain and Italy later this year. The UK approved VYJUVEK in May, and pricing discussions are underway. Additional marketing applications are expected in Switzerland and Australia during the second half of 2026. Krystal ended the quarter with $1.1 billion in cash and investments. The company is advancing multiple clinical programmes across eye, lung, and skin conditions.
Krystal Biotech's share price rose 7.9% following its promotion from the S&P 600 to the S&P 400 index earlier this month. The biotechnology company also joined the S&P 400 Health Care and Biotechnology indices. Additionally, Krystal filed a response with the US Patent and Trademark Office containing single-patient data from its investigational KB801 gene therapy for neurotrophic keratitis. The company noted the data showed complete closure of a persistent corneal epithelial defect in one patient from a discontinued study. Krystal emphasised the early-stage nature of the data and said it should not be used to draw efficacy conclusions. The index inclusion increases the company's exposure to mid-cap index funds. Analysts expect Krystal's investment case remains focused on its VYJUVEK rare disease franchise and upcoming pivotal data across its gene therapy pipeline.
Brown Capital Management's Small Company Fund added Krystal Biotech, Inc. (NASDAQ:KRYS) to its portfolio in the first quarter of 2026, according to its investor letter. The commercial-stage gene therapy company develops treatments for rare skin disorders using topical, re-dosable gene therapy. Krystal's lead product, VYJUVEK, is the first FDA-approved topical gene therapy for dystrophic epidermolysis bullosa. The treatment has exceeded commercialisation expectations with rapid patient adoption and strong payer acceptance, generating gross margins near 94%. The company reported $389 million in revenue for 2025 with a 42% operating margin. Brown Capital expects approximately 30% annual revenue growth and operating margins rising to 50% in coming years. The fund cited Krystal's recession-resistant revenue stream and expansion into European and Japanese markets as key investment drivers.