Mechanical Engineer IV

A career at Resilience is more than just a job – it’s an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. 

For more information, please visit www.resilience.com

Position Summary & Role

The Mechanical Engineer role is a GMP oriented position with substantial experience in Mechanical, Equipment, Process and Control systems pertaining to regulated BSL3/BSL2 Biomanufacturing facility, related product development labs, and warehouses. SME level competency is required on HVAC systems, Boilers, Heat exchangers, Compressors, Processes vessels, Process piping, Sterilizers, Parts washers, Bioreactors, Chromatography skids, equipment used for the production and distribution of clean utilities (USPW, WFI, Compressed gases) and various Buffers and Media. Experience working in GxP cleanroom environment in a regulated industry such as bio-pharmaceutical or medical device is required. 

Job Responsibilities 

• Member of the Engineering Dept and perform the functions of a Responsible System Engineer (RSE) for assigned systems.
• Lead, plan and execute the design, installation, qualification, operation, maintenance, and continuous improvement of mechanical systems as applied to BioPharma manufacturing facility (e.g.: HVAC systems, Boilers, Heat exchangers, Compressors, Processes vessels, Process piping, Sterilizers, Parts washers, Bioreactors, Chromatography skids, equipment used for the production and distribution of clean utilities such as USPW, WFI, Compressed gases and various Buffers and Media). 
• Generate, evaluate, gain approval for an execute continuous improvement projects to save labor, cost of materials, energy and waste in the facilities, production processes or utility systems. 
• Responsible for generating scope of work (SOW), Request for quote (RFI), process flow diagram, layout and detailed drawings for various Projects as required. 
• Technical lead for any issues which may arise in the mechanical, facility, process, and utility, and building infrastructure. 
• Assist other system owners in complex and cross-functional problem solving, project execution, risk reviews, quality events, maintenance, and re-certification, as needed.  
• Serves as Subject Matter Expert (SME) to support and lead assigned work orders, PMs, Maintenance orders and re-qualification. 
• Lead and support deviation investigations, root cause analysis, management of change, and CAPA identification and implementation of related corrective and preventives actions.  
• Lead optimization and improvements to cleanroom related equipment, infrastructure an related operations. 
• Develop SOPs, work instructions, test methods, requirement specifications and other design, operations, and maintenance documents. 
• Collaborate on the preparation/review of design documents, technology transfer protocols, facility fit assessments, risk assessments, as needed. 
• Draft, review, and/or execute user requirement specifications (URS), FRS, FAT, SAT, IQ, OQ, ES, and PQ protocols/reports supporting manufacturing process equipment and facility and infrastructure systems. 
• Ability and experience to work effectively in dynamic, cross-functional teams supporting Manufacturing, Quality Assurance, QC, R&D, PD, BD, EHS, and other departments, as needed. 
• Lead the collection and statistical analysis of equipment, process, and utility data through the use of Building Automation System (BMS) or other process automation platforms.  
• Skilled in troubleshooting of process/equipment systems, root cause and failure tree analysis, and quick turnaround of systems using emergency change controls and Engineering Change Proposal (ECP) and Management of Change (MoC).  
• Working knowledge and hardware and software understanding of PLC, MES, SCADA, Backup, and Access Control systems. 
• Operational understanding of Quality systems and Data Integrity requirements as it pertain to Biopharma/Pharma operations.  
• Ability to read, review and redline process flow diagrams and P&IDs. 
• Experience leading and supervising system installations and Capex projects including managing contractors. 
• Provide technical feasibility assessment and develop proposals for future systems and facility expansions. 
• Well versed in implementing and following safety, health, and environmental requirements as applied to biopharma industry.  
• Systems which this person will interact and support as Process & Critical Syste