Process & Automation Equipment Engineer

Krystal Biotech • Pittsburgh, PA

1d • Onsite

About The Position

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.

Requirements

• 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 (FactoryTalk SE / Ignition / DeltaV) or equivalent
• HMI (FactoryTalk ME / TIA Portal) or equivalent
• Demonstrated experience with instrument or equipment control application software. SME level preferred.
• Basic understanding of facilities/utilities systems (HVAC, cleanrooms)
• 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 analytics for troubleshooting and process improvement
• Exposure to predictive maintenance or anomaly detection is a plus
• Awareness of advanced process control or model-based approaches (nice-to-have)
• Strong troubleshooting mindset for real-time manufacturing support, Experience with root cause analysis (RCA, FMEA), Familiarity with deviation/CAPA processes in GMP environments and Ability to operate effectively at the interface of process, automation, and facilities teams
• Strong cross-functional collaboration (MSAT, QA, Facilities, IT) and Ability to translate process issues into data-driven insights
• Interest in supporting digital / smart manufacturing initiatives
• Strong analytical and troubleshooting skills with a methodical, detail-oriented approach
• Ability to work collaboratively across functions and communicate effectively with both technical and non-technical stakeholders
• Self-starter who can manage competing priorities in a fast-paced, evolving environment
• Excellent written and oral communication skills

Nice To Haves

• Hands-on experience is a plus
• Background in upstream bioprocessing, cell culture, or bioreactor operations is a plus
• SME level preferred.
• Exposure to predictive maintenance or anomaly detection is a plus
• Awareness of advanced process control or model-based approaches

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level