Process Validation Associate / Engineer

About Krystal Bio:

At Krystal Biotech, Inc., we bring together the brightest and most eager minds to relentlessly pursue the discovery, development and commercialization of gene delivery medicines for patients with serious and life-threatening genetic diseases. Founded in 2016, Krystal is a leader in gene therapy. Krystal received U.S. FDA approval for the first-ever redosable gene therapy treatment, VYJUVEK™, for the treatment of Dystrophic Epidermolysis Bullosa. Krystal continues to leverage our proprietary platform to develop new treatments across a robust clinical pipeline. Located near Krystal’s headquarters are two state-of-the-art GMP facilities.

Krystal Biotech is based in Pittsburgh, PA which is home to our two state-of-the-art GMP facilities.  Additional offices are situated in Boston, MA and in Zug, Switzerland.

Join us on our journey to implement our mission to identify, develop and deliver genetic medicines to patents!

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.

Primary 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.

Minimum Qualifications & Desired Competencies:

• 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
• Prior experience in the gene therapy field is desired
• 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

Krystal Biotech, Inc. is an Equal Employment Opportunity and Affirmative Action Employers. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. Headhunters and recruitment agencies may not submit resumes/CVs through this Web site or directly to managers. Krystal Biotech, Inc. does not accept unsolicited headhunter and agency resumes. Krystal Biotech, Inc.  will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc.