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Location:
Newark, Delaware, United States
Job reference: R-051408
Posted date: May. 22, 2019
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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 a Sr. Packaging Engineer in Newark, DE, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.

Global Operations is fundamental to our purpose of delivering life-changing medicines to patients, touching every aspect of our business and providing a platform for everything that we do. We harness the specialist talents of 13,000 people around the world – 20% of our global workforce. With 30 production facilities in 18 countries we’re focused on supplying our medicines with care, quality and efficiency, reducing the time from lab to patient. Keen to bridge the gap between science and patients? Turn research into reality? And forge a global career that’s full of possibilities, as part of a world-class team? Come and thrive in our vibrant, energizing, connected and supportive culture and make a real difference to patients. Hear from our Senior Leaders about why they know AstraZeneca is a great place to work. https://lnkd.in/g8APibK

This position will be second shift.

The Senior PET Engineer is responsible for ensuring one technical process exists within the PET/Facility.  This includes equipment, materials and procedures; overall life cycle management.  Leads projects and improvement initiatives as the technical expert.  Responsible for maintaining a strong relationship with the PET.  Serves as the single point of contact for all technical issues.

Major Responsibilities

  • Ensures there are technical processes with centerlines, standard work, critical process parameters identified, material specs and operating procedures are clear and delivers a quality product
  • Leads or supports the following process improvement efforts: changeover reduction, yield improvements, OEE improvements, waste reduction, and parts management
  • Ensures success criteria for technology transfer and validation is clear and the process is capable and sustainable for the merge into the PET/Facility process
  • Deliver or support PET’s and/or Facility improvement initiatives that define equipment data, equipment capabilities, utilization, efficiencies, obsolescence, and asset management
  • Initiate deviations and performs/facilitates the technical investigations and assessment of impacts
  • Authors or reviews documents including Standard Operating Procedures, Master Batch Records, Material Specs, Rework procedures and other forms
  • Ensuring as built drawings and documentation is completed; including SAP master data updates (equipment, asset, etc) 
  • 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
  • Ensuring projects are designed and installed in compliance with all company standards, SOP policies and guidelines.  All design and construction complies with all Regulatory Agencies, Safety, Health and Environmental codes and regulations
  • Delivery or development of project justification and engineering proposals including PEP, budget and spend management
  • Implement technical training requirements for Operations/Engineering/Maintenance for new and existing processes/equipment
  • Works collaboratively within PET and Engineering Community (local, regional, global)
  • Supports technical trouble shooting (ie above line technical support)
  • Process Owner/SME for regulatory inspections and audits
  • Provides input to, and actively participates, in the annual product and periodic validation review process
  • Maintain external technical relationships and collaborates with equipment and material suppliers
  • Develops and leverages contracting OSP strategies to deliver valued improvements
  • As the Change Leader, ensure that equipment is maintained in a validated state; including management and delivery of applicable OCM Change Control activities (i.e. MBRs, SOPs, etc.)
  • Participates in the SEFM Weekend on Call Program
  • As business needs dictate, requirement to work second, third and weekend shifts to ensure full coverage/oversight for the team and to engage all SEFM personel  in product launches, continuous improvement, system ownership, site shutdown activities, and self directed mechanic and technician work team activities

Requirements:

Education:

  • BS in Engineering, pharmacy or related science

Packaging/Formulation Engineer

  • Training or experience in the applicable following technologies: aseptic/controlled environment, unit operations, formulation, packaging, validation, technology transfer, change control, applied statistics ,mechanics, hydraulics, pneumatics, vacuum technology, electronics, programmable logic controllers, refrigeration, freeze drying, test equipment for electrical and mechanical trouble shooting, HVAC
  • Proficiency in at least one of the following disciplines: equipment, process/materials, maintenance, project delivery
  • Equipment/System/Project/Process Life Cycle Management and Execution including project management (schedule, sanction ,spend, and stakeholders)
  • Solid organization, problem solving and decision-making
  • Solid team work and communication skills (oral and written)
  • Working knowledge of Microsoft Office Suite (Word, Excel, Project)

Packaging/Formulation Senior Engineer

  • Minimum of five (5) years experience in GMP or regulated production environment working with the applicable following technologies: : aseptic/controlled environment, unit operations, formulation, packaging, validation, technology transfer, change control, applied statistics, mechanics, hydraulics, pneumatics, vacuum technology, electronics, programmable logic controllers, refrigeration, freeze drying, test equipment for electrical and mechanical trouble shooting, HVAC
  • Minimum of three (3) years of leadership and project management skills
  • Demonstrated ability to simultaneously manage multiple projects
  • Proficiency in all of the following disciplines equipment, process/materials, maintenance, project delivery
  • Expertise in at least one of the following disciplines equipment, process/materials, maintenance, project delivery
  • Proven ability to work in a global environment to deliver standardization across the business
  • Working knowledge of Microsoft Office Suite (Word, Excel, Project)

Packaging / Formulation Principal Engineer

  • Minimum of eight (8) years experience in GMP or regulated production environment or equivalent post-graduate academic experience with 5 years work experience
  • Expertise in two more of the following discipline equipment, process/materials, maintenance, project delivery
  • Site expert in a specific area applicable to multiple Packaging / Formulation Technologies or Facilities Management
  • Minimun of five (5) years of strong leadership and project management skills
  • Advanced knowledge of cGMPs and FDA policies/procedures including experience interacting with regulatory authorities
  • Ability to work effectively as a leader and /or member of cross-functional team
  • Demonstrated ability to simultaneously manage multiple projects of high complexity
  • Assists the Engineering Leader in aspects of performance management; including team and personnel development, mentoring and coaching of other members of the SEFM team
  • Application of Microsoft Office Suite (Word, Excel, Project) for project delivery
  • Working knowledge of TDMS, SAP, OCM
  • Experience in Six Sigma/ analytical trouble shooting skills
  • Experience working in a LEAN environment

Preferred:

Packaging/Formulation Engineer

  • Strong verbal and written communication skills; influences others to act with full understanding
  • Proven ability to work effectively in a team environment; driving team and personal accountability
  • Ability to generate and interpret technical documents
  • Experienced in managing external technical relationships
  • Strong mechanical/technical aptitude
  • Experienced in working in a LEAN manufacturing environment
  • Working knowledge of TDMS, SAP, OCM, TrakSys

Packaging/Formulation Senior Engineer

  • Advanced technical degree or professional certification
  • Proven experience leading a team of technical personnel
  • Uses their insight to challenge and adapt current approaches/ways of doing things
  • Experience in Six Sigma/ analytical trouble shooting skills
  • Application of Microsoft Office Suite (Word, Excel, Project) for project delivery  
  • Working knowledge of TDMS, SAP, OCM, TrakSys

Packaging/Formulation Principal Engineer

  • Mechanical/technical experience in more than one discipline
  • Management of multiple initiatives across a varied scope
  • Proven ability to develop team dynamics as well as personnel
  • Proven ability to work with all levels within the organization – locally and globally
  • Masters degree in an engineering or related scientific discipline
  • Black Belt Six Sigma certification and experience working in a lean environment
  • Advanced knowledge of TDMS, SAP, OCM, TrakSys

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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Senior Packaging Engineer - Newark, DE - Global Operations
Global Operations

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