Krystal Biotech, Inc. · 2 months ago
Process Validation Associate / Engineer
Pittsburgh, PA
Full-time
Onsite
Entry, Mid Level
1+ years expKrystal Biotech, Inc. is a company focused on the discovery, development, manufacturing, and commercialization of genetic medicines. They are seeking a highly motivated Process Validation Associate or Engineer to support process validation planning, design, and execution, as well as to ensure proper technology transfer between sites.
BiopharmaBiotechnologyHealth Care
Responsibilities
Partner with Process Development and Manufacturing to ensure upstream and downstream processes are well controlled
Apply QbD and traditional process validation principles to existing and new gene therapy products
Perform and document risk assessments to capture existing process knowledge and to identify gaps
Perform experiments (bench scale and manufacturing scale) to close gaps in process understanding and to support process development
Troubleshoot process and equipment issues to help ensure efficiencies in processes
Help implement a continuous improvement mindset to processes and departments
Produce high-quality documentation that meets applicable standards and is appropriate for its intended use
Work on development of new manufacturing facility to ensure proper transfer of technology and processes
Work with CMC counterparts to draft materials intended for the agency review
Qualification
Required
Bachelors' Degree in Chemical Engineering, Biomedical Engineering, or related
Relevant validation and/or engineering experience in the Biotech or Pharmaceutical industry (1+ yr for Associate, 3+ yr for Engineer level)
Background that includes knowledge/experience in GMP, GLP, and statistics
Strong knowledge of GMP and ICH requirements and QbD
Must be a self-starter and capable of working with minimal oversight
Must be able to handle multiple roles and work in a fast paced and changing environment and know how to prioritize activities appropriately
Excellent oral and written communication skills
Preferred
Prior experience in the gene therapy field is desired
Company
Krystal Biotech, Inc.
A commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines for high unmet medical needs.
201-500 employees
H1B Sponsorship
Krystal Biotech, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2022 (1)
2021 (1)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$546MKey Investors
Frazier Healthcare PartnersSun Pharmaceutical Industries
2023-05-21Post Ipo Equity· $160M
2021-11-29Post Ipo Equity· $200M
2021-02-02Post Ipo Equity· $100M
Leadership Team
Suma Krishnan
Founder & President
Recent News
Investor's Business Daily
2025-12-11
Investor's Business Daily
2025-11-12
Company data provided by crunchbase