Facilities Engineer II

Brief Job Description Acts in a leadership role in providing engineering support and technical expertise for GMP and non-GMP, utility systems, and related equipment. Job Responsibilities Create and continuously improve the systems for the elimination of downtime in manufacturing and utilities Support the manufacturing process, with projects to improve the quality, cost and lean manufacturing Support manufacturing in the installation of new processes Ensure proper documentation practices during job activities. Perform visual inspections. Conduct troubleshooting activities. Gather, organize, and communicate operational information to others. Lead and coordinate investigations and studies with little supervision. Use MAXIMO and/or CMMS (Computerized Maintenance Management System) to manage logistics. Provide leadership, development, and mentoring for others. Identify temporary and permanent fixes to address issues. Initiate appropriate action when process deviations occur. Monitor records to ensure compliance with regulatory requirements. Coordinate with representatives from other departments. Attend team meetings to discuss progress, initiatives, and/or other matters. Monitor equipment and/or systems for performance and problem indicators. Read, understand, and comply with cGMP (Good Manufacturing Practices) and SOPs (Standard Operating Procedures), including general safety, lock outs, and so on. Wear gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activities. Perform preventative (scheduled) and corrective/emergency (unscheduled) maintenance of equipment, systems, and/or facilities without supervision. Ensure proper documentation practices during maintenance processes. Maintain equipment and systems along with their certification records. Read and interpret diagrams, drawings, and other schematics. Recommend and initiate activities to ensure area and equipment is maintained in a state of compliance. Monitor air flow and balance. Perform infrared, vibration, pressure, superheat, and subcooling readings. Perform routine sampling activities. Performing high purity water testing. Other Duties: Train others on systems, software, equipment, machines, procedures, and/or processes. Answer compliance and process questions from others. Communicate policies and procedures to employees. Establish visual tracking and other tools to enhance audit readiness and trend analysis. Lead process improvement activities and teams to meet strategic goals. Participate in spill control, handling of hazardous materials, and first aid. Communicate priorities and progress to team on a continuing basis. Facilitate team meetings to discuss progress, initiatives, and/or other matters. Guide others on SOPs (Standard Operating Procedures), control documents, and/or other work instructions. Supervise day to day activities of others. Coordinate activities of support groups. Analyze trends in data in order to provide accurate descriptions, identify root causes, and/or identify solutions or improvements. Close out deviations, CAPAs, and/or pAFCAs as needed. Interact with regulatory agency personnel during audits and inspections. Monitor key performance indicators to meet strategic goals. Perform regular audits of SOPs (Standard Operating Procedures) and/or work instructions. Review and approve documentation needed for qualification of equipment and processes. Write, review, and revise SOPs (Standard Operating Procedures) for maintenance of equipment, systems, and/or facilities. Assist with recruiting/interviewing/evaluating prospective employees. Attend inter-departmental meetings to discuss matters involving the coordination of multiple departments. Facilitate inter-departmental meetings to discuss matters involving the coordination of multiple departments. Interact with other departments to implement corrective/preventative actions. Participate in cross-functional teams to meet strategic goals. Participate in new equipment design specification. Read technical publications and manuals and write associated procedures. Review and approve OCMs, change controls, and document revisions. Collect, record, and report metrics. Execute validation protocols for processes, equipment, packaging, and/or cleaning. Generate validation protocols for processes, equipment, and/or packaging. Assess and implement improvements in productivity, waste generation, quality and cost. Provide input on the engineering of replacement parts. Assist process engineering and managers with improvement projects. Lead committees or groups of employees tasked with accomplishing some objective(s). Conduct presentations (other than training) for different audiences. Consult cross-functionally as an SME (Subject Matter Expert) on systems and/or processes within a functional area. Coordinate qualification activities. Create specifications for equipment. Create, generate, type, proof, and distribute correspondences. Design and deploy new machines. Answer questions from others regarding parts, capital, sending parts out for repair, purchasing, and/or reliability. Lead change control activities. Lead teams in root cause analysis sessions. Manage small- and mid-scale capital projects to ensure on-time and in-budget completion. Coordinate the activities of third-party personnel. Manage the design, implementation, and support of site-wide process automation, supervisory control, and data acquisition (SCADA) solutions. Manage supplier activities during design, fabrication, installation, commissioning, and qualification. Organize shut downs and/or maintenance windows. Oversee validation activities. Perform gap analyses and assessments for integration. Perform LDAR (Leak Detection and Repair) monitoring. Provide 24/7 "on-call" support to others. Provide, verify, measure, and revise drawings. Recommend compliance resolutions to management. Review and approve requirements, specifications, drawings, coding procedures, and guidelines. Serve as SME (subject matter expert) and/or primary point of contact for various safety initiatives (for example: quarterly departmental safety inspections, fire and light safety, industry safe program, process safety management program). Wear harnesses to climb into tanks. Education, Qualifications, Skills and Experience Minimum Requirements: Minimum of 2 years of experience supporting facilities engineering within a regulated or cGMP environment. Knowledge of machine safety applications, maintenance systems, industrial processes, electrical systems, electrical wiring diagrams, safety, electrical code, and safety laws Preferred Requirements: Bachelor’s degree Experience with electrical, HVAC, AMHS, Clean Utilities equipment experience. Experience utilizing SAP PM. Experience utilizing CMMS Experience with machine hydraulics, machine pneumatics, machining, maintenance, fabrication, fire protection systems, PLC machine logic, motor controllers and servo drives. Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $68,500.00 - $86,875.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters. RESILIENCE is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. RESILIENCE will offer the highest quality and regulatory capabilities, and flexible and adaptive facilities to serve partners of all sizes. By continuously advancing the science of biopharmaceutical manufacturing and development, RESILIENCE frees partners to focus on the discoveries that improve patients’ lives. Please Note – Resilience does not accept unsolicited agency resumes. Resilience will not pay any third-party agency or company that does not have a signed agreement with Resilience. Culture Focus Sites

Salary : $68,500 - $0