ZipRecruiter
Johnson Service Group, a nationally award-winning staffing firm, is looking to hire a
Senior Equipment Engineer
for a biotech company in Carlsbad, CA. We seek a skilled Senior Equipment Engineer to support the operation, upkeep, and continuous enhancement of manufacturing systems within a cGMP-compliant, FDA-regulated biopharmaceutical facility. This role requires in-depth technical knowledge of automated equipment and strong problem-solving capabilities to ensure system reliability and minimize production disruptions. Key Responsibilities: Provide hands-on and technical support for manufacturing systems such as automated filling lines, isolators, environmental monitoring devices, and building management systems. Diagnose and resolve issues with automation and control systems to reduce equipment downtime. Program, modify, and configure PLCs (Allen-Bradley, Siemens), SCADA systems, and HMI interfaces for production use. Work closely with service technicians and vendors to coordinate and execute maintenance, system upgrades, calibrations, and repairs. Lead and optimize preventive and predictive maintenance strategies for key production equipment. Generate and maintain documentation, including system specs, SOPs, calibration records, validation protocols, deviation reports, CAPAs, and change control records in compliance with cGMP standards. Partner with cross-functional teams, including Manufacturing and Quality, to drive process improvements and operational efficiency. Act as a technical resource and subject matter expert during audits and regulatory inspections. Manage multiple priorities effectively in a fast-paced environment while adhering to project timelines. Support occasional off-hours, including nights or weekends, based on production needs. Qualifications: Minimum of 5 years of relevant experience in equipment engineering within a regulated biopharma manufacturing setting. A bachelor’s or Master’s degree in Engineering or a related technical field. Familiarity with aseptic processing and sterile production environments. Solid understanding of regulatory requirements, including ISO 13485, 21 CFR Parts 11, 210, 211, and 820, and EU Annex 1. Proficient in drafting and reviewing technical documentation, SOPs, and validation/qualification materials. Experienced in leading equipment-related investigations and implementing CAPAs. Strong attention to detail with analytical and problem-solving skills. Proficiency in Microsoft Office tools (Word, Excel, PowerPoint, Outlook). Excellent written and verbal communication skills.
#J-18808-Ljbffr
Senior Equipment Engineer
for a biotech company in Carlsbad, CA. We seek a skilled Senior Equipment Engineer to support the operation, upkeep, and continuous enhancement of manufacturing systems within a cGMP-compliant, FDA-regulated biopharmaceutical facility. This role requires in-depth technical knowledge of automated equipment and strong problem-solving capabilities to ensure system reliability and minimize production disruptions. Key Responsibilities: Provide hands-on and technical support for manufacturing systems such as automated filling lines, isolators, environmental monitoring devices, and building management systems. Diagnose and resolve issues with automation and control systems to reduce equipment downtime. Program, modify, and configure PLCs (Allen-Bradley, Siemens), SCADA systems, and HMI interfaces for production use. Work closely with service technicians and vendors to coordinate and execute maintenance, system upgrades, calibrations, and repairs. Lead and optimize preventive and predictive maintenance strategies for key production equipment. Generate and maintain documentation, including system specs, SOPs, calibration records, validation protocols, deviation reports, CAPAs, and change control records in compliance with cGMP standards. Partner with cross-functional teams, including Manufacturing and Quality, to drive process improvements and operational efficiency. Act as a technical resource and subject matter expert during audits and regulatory inspections. Manage multiple priorities effectively in a fast-paced environment while adhering to project timelines. Support occasional off-hours, including nights or weekends, based on production needs. Qualifications: Minimum of 5 years of relevant experience in equipment engineering within a regulated biopharma manufacturing setting. A bachelor’s or Master’s degree in Engineering or a related technical field. Familiarity with aseptic processing and sterile production environments. Solid understanding of regulatory requirements, including ISO 13485, 21 CFR Parts 11, 210, 211, and 820, and EU Annex 1. Proficient in drafting and reviewing technical documentation, SOPs, and validation/qualification materials. Experienced in leading equipment-related investigations and implementing CAPAs. Strong attention to detail with analytical and problem-solving skills. Proficiency in Microsoft Office tools (Word, Excel, PowerPoint, Outlook). Excellent written and verbal communication skills.
#J-18808-Ljbffr