Senior Process Engineer

Independently lead assigned engineering projects as well as support moderate to large sized engineering projects. This includes process and equipment design, project management, and project engineering. Drive projects to completion to meet quality, timeline and budget objectives. Manage all assigned equipment design, procurement and startup, including specification development, procurement activities, FAT/SAT, installation, commissioning, debugging, optimization and validation support. Support development laboratories and manufacturing operations including optimization and troubleshooting of operational issues in manufacturing, equipment, maintenance, validation, or capital projects. Provide technical engineering support and ownership for investigations, deviations and CAPAs. Additionally, provide inspection support including inspection-readiness and response assistance, where applicable. Develop, evaluate, and implement cost-effective equipment, facility and utility engineering solutions Support enhancements / development of engineering documentation, technical standards, guidelines, and procedures in accordance with industry best practices Promote a culture of safe and compliant design and operation Support process and automation system designs and project lifecycle activities Bachelor's degree in Chemical Engineering or related technical field 6+ years of relevant work experience - including design, capital projects, and operations support for the biopharmaceutical industry. Knowledge of biopharmaceutical processes, including oligonucleotide synthesis, chromatography, ultrafiltration systems, evaporation systems, and solvent handling/distribution systems. Knowledge of GMP process utility systems including high purity water (WFI), CIP, process waste, etc. Excellent troubleshooting skills; ability to react quickly to understand and solve problems Strong understanding of GMPs and good engineering practice (GEP), including industry standards and guidelines, such as, ASME BPE, ISPE Baseline Guides, CFR's, OSHA, ISA S88, GAMP, ASTM E2500, etc.