Process & Automation Equipment EngineerJob 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 (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
