Process Engineer - GMP

Description:
Are there specific educational/software requirements needed?Master’s degree OR Bachelor’s degree in Engineering & 2 years of Engineering experience Shift: 1st or 2nd
What attributes (i.e. - preferred qualifications) would make this candidate stand out?Experience working in a GMP-regulated environment within the pharmaceutical, medical device, or biotechnology industry Proficiency in technical report writing Effective communication skills in both Spanish and English (verbal and written) Familiarity with packaging equipment, process characterization, validation, monitoring, and optimization techniques Strong problem-solving skills and experience conducting root cause investigations Expertise in identifying and managing Corrective and Preventive Actions (CAPAs) Proficiency in statistical analysis and Design of Experiments (DOE) methodologies Ability to apply engineering principles to solve technical issues in a production environment Availability to support non-standard shifts, including extended hours, nights, weekends, and holidays

SUMMARYUnder general supervision, provides characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects. Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of minor scope and complexityFUNCTIONS1. Provide solutions to a variety of technical problems of moderate scope and complexity. 2. Under general supervision will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems. 3. Perform assignments that have clear and specific objectives and require investigation of limited number of variables. (*)4. Initiate and complete routine technical tasks. Operations Engineering:1. Function as a technical expert to equipment or systems regarding troubleshooting operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve complex problems. (*)2. Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of significant complexity. (*)3. Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications. (*)Design Engineering:1. Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints. (*) 2. Work with consultants, architects and engineering firms on development of standard design documents. (*)3. Obtain and critique quotes for equipment modifications or installations. 4. Generate rudimentary project cost estimates and schedules. * Other functions may be assignedEDUCATIONMaster?s degree OR Bachelor?s degree in Engineering & 2 years of Engineering experience PREFERRED QUALIFICATIONS? 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? Demonstrated skills in the following areas: o Problem solving and applied engineering. o Basic technical report writing? Verbal communication? Comprehensive understanding of validation protocol execution requirements.? Demonstrated Skills in the following areas: o Basic technical presentations o Personal Organization o Validation Protocol Writing o Dealing with and managing change o Technical (Equipment Specific) o Analytical Problem Solving o Computer Literacy