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Principal Process Engineer

ROLE SUMMARY The primary role of the TS Principal Scientist is the application of advanced manufacturing, science and technology processes to a given production segment by: Serving as a scientific and technical representative for process-related issues at the facility. Partnering with manufacturing to meet the production schedule, ensure commercial supply , uphold quality standards and driving towards zero defects Performing trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift. Identifying and implementing potential process improvements in conjunction with manufacturing operations. Participating in start-up efforts of new equipment, software or processes in manufacturing. Assisting in documenting changes/updates to manufacturing processes and working with manufacturing, engineering and validation to implement those changes. Reviewing/providing feedback and technical/scientific support on project deliverables, i.e. remediation initiatives, plan reports, etc. Establishing small-scale production processes and using scaled-down lab processes to enable process troubleshooting. ROLE RESPONSIBILITIES Participates on technical team for discrepancy and investigation resolution, equipment and process validation activities, training on new process technologies and on significant changes to manufacturing procedures Proposes process improvement opportunities and/or corrective actions to increase yield, maximize capacity, reduce costs and decrease process variability while maintaining regulatory compliance. Provides technical support for equipment and process validation activities conducts process overview training to support implementation of new process technologies and assists in defining the scope of capital projects. Executes lists of potential process improvements, creates data packages by justifying and outlining recommendations for changes to or improvements in production processes and collaborates with technical staff to implement process technology initiatives. Supports change management and implementation for changes to the manufacturing processes and associated systems, provides training for technical staff on major changes to processes, equipment and documentation Executes laboratory runs and writes technical reports summarizing laboratory results, generating necessary lab data to support product impact assessments during discrepancies and investigations. QUALIFICATIONS BS in Science, chemistry or biology required. Master's degree preferred. Minimum of 8 years experience in Process Engineering, pharmaceutical industry or equivalent education preferred. Familiar with global regulations on devices, drugs, validation/qualification requirements. Excellent communication skills and attention to details. 8 years experience in a manufacturing site. 5 or more years in a pharmaceutical facility. PHYSICAL/MENTAL REQUIREMENTS No unique physical requirements Mental: Remains organized & positive in ambiguous and fast-paced, rapidly changing situations Ability to analyze data from detailed schedule and risk management tools Interface effectively with multiple stakeholder groups Ability to appropriately manage ambiguity and work autonomously Develop positive relationships with multiple manufacturing disciplines 4718321
Salary Range: NA
Minimum Qualification
8 - 10 years

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