Process Engineer II (MSAT) - Dayshift

Job Responsibilities

• Ensures there is 1 technical process with centerlines, critical process parameters, material fit for use, and operating procedures are clear and delivers a capable process.
• Leads the following continuous process improvement efforts: changeover reduction, yield improvements, OEE improvements, maintenance reliability and waste reduction for improvement of automated pharmaceutical manufacturing equipment.
• Ensures success criteria for technology transfer and validation is clear and the process is capable for the merge into the Manufacturing/Facility process.
• Generates a variety of URS, FAT, SAT, commissioning, and IQ/OQ/PQ protocols/ reports.
• Covers coordination and support for Manufacturing/Facility improvement initiatives that define equipment data, equipment capabilities, utilization, efficiencies, and obsolescence.
• Manages life cycle of assets. Maintain external technical relationships and collaborate with equipment and material suppliers.
• Identifies, develops, generates, and manages implementation of appropriate change controls to improve processes and address root causes identified in investigations.
• Performs and maintains risk management activities for new and existing processes / equipment.
• Initiates deviations and performs/facilitates the technical investigations and assessment of impacts.
• Authors and review documents including Standard Operating Procedures, Batch Records, Rework procedures and other forms.
• Author, review and approve validation and change control documents such as master plans, protocols, summary reports and change requests.
• Provides input and develops user requirements for new asset procurement.
• Provides engineering and project management services.
• Aids in the development of project justification and engineering proposals including providing input for capital planning process.
• Identifies and supports technical training requirements for Operations/Engineering/Maintenance for new and existing processes/equipment.
• Performs routine validation and periodic reviews activities.
• Supports and leads technical trouble shooting.
• On-call support as required.
• Key contact for regulatory inspections as technical process owner.
• Participates in annual product review process.
• Participates in biennial critical systems review process.
• Responsible for process validation required because of changes to validated processes within Manufacturing.

Minimum Requirements

• Training or experience in the applicable following technologies: mechanics, hydraulics, pneumatics, vacuum technology, electronics, programmable logic controllers, HMI, Historian/reporting, computerized systems, vision systems, refrigeration, test equipment for electrical and mechanical trouble shooting, aseptic/controlled environment, unit operations, formulation, packaging, process validation, cleaning validation, technology transfer, change control, applied statistics.
• Ability to support manufacturing operations through data analysis, deviation investigations, and root cause analysis.
• Ability to develop proficiency in all the following disciplines: automation/ controls, packaging equipment, process/materials, maintenance, validation.
• Strong attention to detail and problem solving skills.
• Self-starter.
• Ability to work effectively with Manufacturing, Quality, Regulatory, and other technical teams.
• Strong communication skills, both written and verbal.

Preferred Background

• Bachelor’s degree in engineering, or related science.
• Experience in GMP or regulated production environment.
• Experience in Project management.
• Uses their insight to challenge and adapt current approaches/ways of doing things.
• Experience in Six Sigma/ analytical trouble shooting skills.
• Experience working in a LEAN manufacturing environment.
• Expertise in at least one of the following disciplines: automation/ controls, aseptic/ packaging equipment, process/materials, maintenance, validation.
• Ability to coach and mentor peers.

Work Schedule

8 hours - Monday- Friday

Physical Requirements

• Frequent (60-100% of time): Sitting
• Occasional (20-60% of time): Standing, Walking, Wearing Personal Protective Equipment
• Infrequent (