Engineer, Packaging - West Chester, OH | Biospace
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Engineer, Packaging

AstraZeneca Pharmaceuticals LP

West Chester, OH
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Location: West Chester,
United States
Job reference: R-009167

Posted date: Jun. 30, 2017

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As an Engineer, Packaging in West Chester, OH you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.

This is a Blended Role: of automation engineer, production/ process engineer, packaging engineer, validation engineer, and related levels. Shift Engineer, Packaging is assigned to a specific shift.

As the Engineer, Packaging, you are responsible for ensuring one technical process exists within the PET (Process Execution Team)/Facility. This includes equipment, materials, process, and procedures with applicable validation. 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 Technical Operations and Quality areas, as well as, collaborating within the PET/Facility and with other PET Engineers. You will serve as the single point of contact for all technical issues.

Essential Job Functions:
• Ensures 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 PET/Facility process
• Generates a variety of URS (User Requirements Specification), FAT (Factory Acceptance Test), SAT (Site Acceptance Test), commissioning and IQ (Installation Qualification) /OQ (Operational Qualification) / PQ (Performance Qualification) protocols/ reports
• Coordinate and support PET’s/Facility improvement initiatives that define equipment data, equipment capabilities, utilization, efficiencies and obsolescence. Manages life cycle of assets.
• Maintain external technical relationships and collaborates with equipment and material suppliers (e.g., packaging)
• Identify, develop, generate and manage implementation of appropriate change controls to improve processes and address root causes identified in investigations
• Perform and maintain risk management activities for new and existing processes (e.g., new package introductions, etc.) / equipment
• Initiate deviations and performs/facilitates the technical investigations and assessment of impacts (e.g., related to packaging materials)
• Authors and review documents including Standard Operating Procedures (SOPs), 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
• Provide packaging engineering and project management services
• Assist in the development of project justification and engineering proposals including providing input for capital planning process
• Identify and support technical training requirements for Operations/ Engineering/ Maintenance for new and existing processes/equipment
• Perform routine validation and periodic reviews activities
• Works collaboratively within PET as well as with other PET Engineers and
Technology Community (i.e.,Technology and Engineering, global colleagues)
• Supports and leads technical trouble shooting (e.g., packaging materials, etc.,)
• 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 as a result of changes to validated processes within the PET.

Essential Requirements:
• BS in Engineering, or related science
• Training or experience in the applicable following technologies: mechanics, pneumatics, electronics, programmable logic controllers, HMI, Historian/reporting, computerized systems, vision systems, equipment for electrical and mechanical trouble shooting, qualification and validation.
• Proficiency in at least one of the following disciplines: automation/ controls, packaging equipment, validation

Desired 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 and trouble shooting skills

Internal/External Contacts & Customers:
• Technology and Engineering
• Quality Assurance
• Technology Community – globally
• Regulators
• Vendors
Travel Requirements / Work Times:
• 5 % Travel for Vendor and Supplier Visits and Meetings
• Work Times: Shift work a(6pm-6am), Weekends and Off hour call in support

Reporting Relationship:
Direct Reports- 0
Indirect Reports- 1-12 (mechanics, technicians, engineers)

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.


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