Process Validation Associate / Engineer

Krystal Biotech • Pittsburgh, PA

63d

About The Position

At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high unmet medical needs. Founded in 2016, Krystal is distinguished in three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our commercial scale facilities, and a unique commercialization model that focuses on the patient’s end-to-end experience. Krystal received U.S. FDA approval for the first and only redosable gene therapy treatment, VYJUVEK®, for the treatment of Dystrophic Epidermolysis Bullosa (DEB). Krystal continues to leverage our proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology. Krystal is headquartered in Pittsburgh, PA, which is home to our two state-of-the-art CGMP manufacturing facilities with teams around the world and satellite offices in Switzerland, Germany, and Japan. We are a company built and run by people who care, are fearless in the face of a challenge, love the work they do, and practice the highest level of scientific integrity. As we grow, we are seeking team members that embody these values. Job Description Summary: Krystal Biotech is seeking a highly motivated Process Validation Associate (1+ years’ experience) or Engineer (3+ years’ experience) to support process validation planning, design, and execution. This person will be responsible for risk assessments, process improvements, investigations, and other projects. They will also play a pivotal role in technology transfer and ensuring processes transition properly from site to site.

Requirements

• 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

Nice To Haves

• Prior experience in the gene therapy field is desired

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees