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Location:
Newark, Delaware, United States
Job reference: R-042572
Posted date: Jan. 10, 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 an Engineer / Senior Engineer - Continuous Process Verification 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

Business Process owner and Process Champion for Continuous Process Verification (CPV). Leads projects and improvement initiatives as the technical expert.Responsible for maintaining a strong relationship with the PETs.Serves as the single point of contact for CPV and Discoverant.

This position will be hired at either an Engineer or Sr. Engineer level depending on the qualifications of the successful candidate.

Major Responsibilities

  • Ensures there are technical processes with centerlines, standard work, critical process parameters identified, and operating procedures are clear and delivers a quality product
  • Subject Matter Expert (SME) for Discoverant software.
  • Performs statistical analysis/trending of batch data, specifically process control and capability charts.
  • Provides reports and presentations on a routine basis. Reviews data and reports to monitor Formulation and Packaging activities; evaluates and implements methods for improving the operation.
  • Collaborates with Manufacturing Science and Technology and PETs to ensure alignment of Monitoring Plans and Continued Process Validation (CPV) Activities.
  • Leads and/or participates in out-of-trend investigations. Participates and represents Formulation and Packaging as needed in fact finding meetings.
  • Establishes and maintains appropriate training curricula for CPV role.
  • Effectively communicates and escalates issues as appropriate to Quality, Site Services, and PET Area Management.
  • Collaborates with Tech Services, PETs, and Quality to optimize process control, productivity, and product quality.
  • Author and reviewvalidation and change control documents such as master plans, protocols, summary reports and change requests
  • Provides input for new asset procurement
  • 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
  • As the Change Leader, ensure that Discoverant is maintained in a validated state; including management and delivery of applicable OCM Change Control activities (i.e. MBRs, SOPs, etc.)
  • Performs other duties as assigned to support Technical Services Operations.

Qualifications:

Education:

  • BS in Engineering, Statistics or related science

Required:

Engineer - CPV

  • 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.
  • Experience in the use of automated and computerized systems to trend process capabilities.
  • 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)

Senior Engineer - CPV

  • Minimum 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 experience in the use of automated and computerized systems to trend process capabilities.
  • Minimum of three (3) years' of experience of leadership and project management skills
  • Demonstrated ability to simultaneously manage multiple projects
  • 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)
  • Working knowledge of TDMS, SAP, OCM
  • Experience in Six Sigma/ analytical trouble shooting skills
  • Ability to generate and interpret technical documents
  • Advanced technical degree or professional certification

Preferred:

Engineer - CPV

  • 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

Senior Engineer - CPV

  • 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

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 Engineer Continuous Process Verification - Newark, DE - Global Operations
Engineering

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