Process Validation Associate / Engineer

Krystal Biotech • Pittsburgh, PA

64d

About The Position

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 field.
• 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.

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

• Career Level: Entry Level
• Education Level: Bachelor's degree
• Number of Employees: 251-500 employees