Bayer HealthCare LLC

Quality Project Engineer for Saxonburg, PA to support quality engineering initiatives within manufacturing operations; develop & maintain quality engineering methods to meet customer, internal and regulatory requirements; evaluate existing quality system & manufacturing processes and implement projects to improve productivity and efficiency; provide QA project support for site New Product Development engineering introductions; create quality plans; conduct FMEA. Requires Master's in Industrial or Quality Engineering or closely related field and 3 yrs experience developing, supporting & maintaining quality engineering methodologies for large-scale manufacturing to meet customer and regulatory requirements; addressing quality issues & production output with internal stakeholders in a GxP environment; leading and/or supporting manufacturing validation activities, including IQ, OQ, PQ and test method validation, in accordance with ISO standards; using Six Sigma, A3,...

Senior Plant Engineer for Saxonburg, PA to provide engineering support within manufacturing plant operations; identify, evaluate & resolve equipment deficiencies and process bottlenecks; maintain technical equipment documentation & records; plan & execute capital equipment investment projects; ensure regulatory compliance for medical device manufacturing operations. Requires Bachelor's in Mechanical Engineering, Mechatronics Engineering, Engineering Management or closely-related field & 2 yrs experience troubleshooting & repairing automation and packaging equipment; identifying, evaluating & resolving deficiencies and bottlenecks using key performance indicators, including Overall Equipment Effectiveness, Unplanned Downtime, Mean Time Between Failures and/or Mean Time To Repair; providing technical escalation support for production equipment unplanned downtime & inefficiencies; maintaining technical documentation & records, including equipment...