Process Validation Associate / Engineer

ZipRecruiter; Pittsburgh (Allegheny County); On-site; USD 60,000 - 100,000; Full time

Job summary

An innovative company in the biotech sector is seeking a dedicated Process Validation Associate or Engineer to join their dynamic team. This role involves supporting process validation planning and execution, ensuring the seamless transition of processes between sites. The ideal candidate will have a solid foundation in chemical or biomedical engineering, with experience in the biotech or pharmaceutical industry. Join a forward-thinking firm that is committed to scientific integrity and patient-focused solutions, where your contributions will directly impact the advancement of groundbreaking genetic therapies.

Qualifications

• 1+ years experience in biotech or pharmaceutical process validation.
• Strong understanding of GMP, GLP, and ICH requirements.

Responsibilities

• Support process validation planning, design, and execution.
• Conduct experiments to address process understanding gaps.
• Produce high-quality documentation meeting applicable standards.

Skills

Process Validation

Risk Assessment

GMP Knowledge

Communication Skills

Continuous Improvement

Education

Bachelor's Degree in Chemical Engineering

Bachelor's Degree in Biomedical Engineering

Tools

Statistical Analysis Software

Job description

Job Description

About Krystal Bio:

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, with two state-of-the-art CGMP manufacturing facilities and teams around the world, including satellite offices in Switzerland, Germany, and Japan. We are a company built and run by people who care, are fearless in the face of challenges, love their work, and practice the highest level of scientific integrity. As we grow, we seek team members who 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. Responsibilities include risk assessments, process improvements, investigations, and technology transfer, ensuring smooth transition of processes between sites.

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 identify gaps.
• Conduct experiments (bench and manufacturing scale) to address process understanding gaps and support development.
• Troubleshoot process and equipment issues to maintain efficiency.
• Promote continuous improvement in processes and departments.
• Produce high-quality documentation meeting applicable standards.
• Assist in developing new manufacturing facilities and transfer of technology.
• Collaborate with CMC teams to prepare materials for regulatory review.

Minimum Qualifications & Desired Competencies:

• Bachelor's Degree in Chemical Engineering, Biomedical Engineering, or related field.
• Relevant validation and/or engineering experience in biotech or pharmaceutical industry (1+ years for Associate, 3+ years for Engineer).
• Knowledge/experience in GMP, GLP, and statistics.
• Strong understanding of GMP, ICH requirements, and QbD.
• Experience in gene therapy is preferred.
• Self-starter with minimal oversight capability.
• Ability to handle multiple roles in a fast-paced, changing environment with proper prioritization.
• Excellent communication skills, both oral and written.

Krystal Biotech is an Equal Opportunity Employer. We consider all qualified applicants without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other protected status. We do not accept unsolicited resumes from headhunters or agencies without a signed agreement. We will not pay fees to third-party agencies without such agreements.

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