Sr. Process Execution Team (pet) Engineer – Bottles & Diprivan (newark; De)
AstraZeneca (Delaware, Delaware)

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Description:
The Sr. Process Execution Team (PET) Engineer is responsible for ensuring one technical process exists within the PET/Facility. This includes equipment, materials and procedures. Leads improvement initiatives as the technical expert and acts as the first line of support for all project related work. Responsible for maintaining a strong relationship with the Technology and Engineering areas, as well as, collaborating within the PET/Facility and with other PET Engineers. Serves as the single point of contact for all technical issues.

Major Responsibilities
· Ensures there is one technical process with centerlines, critical process parameters, material fit for use, material specs and operating procedures are clear and delivers a capable process
· Leads the following process improvement efforts: changeover reduction, yield improvements, OEE improvements and waste reduction
· Ensures success criteria for technology transfer and validation is clear and the process is capable for the merge into the PET/Facility process
· Coordinate and support PET’s/Facility improvement initiatives that define equipment data, equipment capabilities, utilization, efficiencies and obsolescence
· Initiate deviations and performs/facilitates the technical investigations and assessment of impacts
· Authors and review documents including Standard Operating Procedures, Batch Records, Material specs, Rework procedures and other forms. Author and review 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 minor project management services
· Assists in the development of project justification and engineering proposals including providing input for capital planning process
· Identifies technical training requirements for Operations/Engineering/Maintenance for new and existing processes/equipment
· Performs routine validation/maintenance activities
· Works collaboratively within PET as well as with other PET Engineers and Technology Community (i.e., technology and Engineering, global colleagues)
· Supports technical trouble shooting
· Key contact for regulatory inspections as process owner
· Co-ownership of life cycle management of assets
· Participates in annual product review process
· Maintains external technical relationships and collaborates with equipment and material suppliers
· Participates in biennial critical systems review process
· Responsible for process validation required as a result of changes to validated processes within the PET

Responsibilities

· BS in Engineering, pharmacy or related science
· Minimum 4 years experience in cGMP or regulated production environment
· Training or experience in the applicable following technologies: mechanics, hydraulics, pneumatics, vacuum technology, electronics, programmable logic controllers, refrigeration, freeze drying, test equipment for electrical and mechanical trouble shooting, HVAC, aseptic/controlled environment, unit operations, formulation, packaging, validation, technology transfer, change control, applied statistics
· Proficiency in all of the following disciplines: equipment, process/materials, maintenance and project delivery
· Expertise in at least one of the following disciplines equipment, process/materials, maintenance, project delivery

Preferred Background
· Strong verbal and written communication skills
· Proven ability to work effectively in a team environment
· Ability to generate and interpret technical documents
· Experience managing external technical relationships
· Strong mechanical/technical aptitude
· Advanced technical degree or professional certification
· Proven experience leading a team of technical personnel
· Project management
· Uses 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