Process & Automation Equipment Engineer

Process & Automation Equipment Engineer

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, 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 motivated and data-driven manufacturing engineer to lead troubleshooting efforts and optimization of GMP manufacturing processes. The Engineer will integrate process engineering, automation, and data analytics, while supporting the development of data-driven monitoring and predictive maintenance programs, along with intelligent manufacturing capabilities. This role is ideal for an engineer with a passion for automation and process optimization, with interest in becoming a subject matter expert on the control systems that drive our gene therapy manufacturing platform.

This role serves as a technical bridge between Manufacturing, Automation, and Facilities, ensuring seamless integration of process equipment, control systems maintenance, and facility infrastructure.

Primary Responsibilities:

* Act as the primary interface between Manufacturing, Automation, and Facilities teams to diagnose and resolve process and equipment issues spanning control systems, utilities, and unit operations.

* Support day-to-day upstream manufacturing operations, ensuring equipment and processes are operating within validated parameters.

* Develop deep familiarity with control systems (PLCs, HMIs, and SCADA) associated with manufacturing processes with a long-term goal to predictive maintenance of process equipment

* Partner with the Automation and Facilities teams to troubleshoot issues across process equipment, control systems, and supporting utilities (HVAC, gases, etc.)

* Identify opportunities to optimize existing automation configurations, batch record workflows, and data collection tools to improve process efficiency and data integrity.

* Assist in the authoring and review of SOPs, batch records, work orders, change controls, and deviations related to upstream process and automation activities.

* Support equipment qualification, process validation, and technology transfer activities as they relate to upstream systems and associated control infrastructure.

* Collaborate with Process Development and Manufacturing Sciences to ensure alignment between process design intent and real-world automation behavior.

* Contribute to continuous improvement initiatives and help foster a culture of proactive problem-solving across CMC functions.

Minimum Qualifications & Desired

Competencies:

* Bachelor's degree in Engineering, or a relevant technical field

* Prior experience in a regulated manufacturing or process engineering environment is preferred (biotech, pharmaceutical, or adjacent industry)

* Exposure to industrial automation systems such as PLCs, HMIs, and/or SCADA platforms; hands-on experience is a plus

* Familiarity with GMP principles and documentation standards

* Background in upstream bioprocessing, cell culture, or bioreactor operations is a plus

* Solid process engineering background in biologics / CGT GMP manufacturing

* Hands-on experience with process equipment troubleshooting (e.g., Bioreactors/ skids/ fillers/ mixers and single-use systems)

* Working knowledge of process controls and automation systems (hands-on experience with at least one platform preferred)

* PLC (Allen-Bradley, Siemens) or equivalent

* SCADA (Factory Talk SE / Ignition / Delta

V) or equivalent

* HMI (Factory Talk ME / TIA Portal) or equivalent

* Demonstrated experience with instrument or equipment control application software. SME level preferred.

* Basic understanding of facilities/utilities systems (HVAC, clean rooms)

* Experience with process data and historians (e.g., OSI PI) and Familiarity with data analysis tools (e.g., Excel, Python, or similar)

* Interest in applying data…