Sr Engineer

Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity

Responsibilities

Own change controls for manufacturing process changes; Support major/trend deviation investigations throughout the whole lifecycle including Root Cause Analysis investigation, determination of Corrective/Preventive Actions, authoring process investigation reports, and presenting within regulatory inspections; Support Risk Assessments exercises and Microbial assessment evaluations; Led commercial campaign readiness and effectively communicate and collaborate with cross function areas; Assist in the generation of training materials and assist in providing training on scientific or technical aspects of the process; Provide commercial support when needed and assist on the floor troubleshooting; Design, coordinate, and support execution of functional tests, water tests, and other runs to challenge process and operations during major changes, or campaign readiness; Generate technical protocols as needed; Assist and provide guidance during MBR (Master Batch Record) creation/revisions; Perform assessment to support process, automation, or equipment modification or implementation of special projects; Initiate, revise, and approve standard manufacturing procedures; Ensure all procedures reflect current operations; Serve as a document owner; Assess process performance and review of performance data; Evaluate, plan, and implement solutions for process improvement opportunities; Complete assessments for CAPA applicability requests from other plants/sites; Complete assessment for new or changes in BOM's (Bill of Materials); Serves as a peer-recognized specialist in at least one area, with overall responsibility for determining methodologies in that area.

Requirements

Doctorate OR Masters + 2 years of Engineering experience OR Bachelors in Engineering + 4 years of Engineering experience; Working knowledge of pharmaceutical/biotech processes; Familiarity with validation processes; Familiarity with documentation in a highly regulated environment; Ability to operate specialized laboratory equipment and computers as appropriate; Ability to interpret and apply GLPs and GMPs; Ability to apply engineering science to production; Able to develop solutions to routine technical problems of limited scope; Problem solving and applied engineering; Basic technical report writing; Verbal communication; Comprehensive understanding of validation protocol execution requirements.

Nice to have

Manufacturing Equipment ownership at CMMS system (Work orders approval, closing, PM strategy, spare parts' definition/accuracy/updates), reliability and change control assessments and requirements; Collaborate with Engineering Staff to ensure the best maintenance strategy on manufacturing equipment operations; Responsible for enhancing system reliability focusing on equipment availability, downtime reduction and maintenance optimization; Develop equipment performance metrics (availability, downtime, etc.) with emphasis on identifying equipment performance improvement opportunities; Lead the implementation of equipment improvements projects; SME (Subject Matter Expert) for systems regarding design, maintenance and point of contact during compliance operations; Support equipment troubleshooting within the functional area or in the scope of technical expertise; Support deviation process and define, Implement and own CAPAs associated to equipment within area of expertise; Drives Environmental, Health and Safety compliance within the organization

Benefits

Medical, dental, and vision care; Comprehensive suite of benefits focusing on physical, emotional, financial, and social wellness; Support for working families; Backup dependent care; Adoption assistance; Infertility coverage; Family building support; Behavioral health solutions; Paid parental leave; Paid caregiver leave; Training programs; Professional development resources; Opportunities to participate in mentorship programs, employee resource groups, volunteer activities