The Senior / Principal PET Engineer (Process Execution Team) 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
  • Insures there is 1 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
  • Insures 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
  • Provide engineering and minor project management services
  • Assist in the development of project justification and engineering proposals including providing input for capital planning process
  • Identify technical training requirements for Operations/Engineering/Maintenance for new and existing processes/equipment
  • Perform 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
  • Maintain 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.
    Requirements Minimum Requirements
  PET Senior Engineer
  • BS in Engineering, pharmacy or related science
  • Minimum 4 years experience in GMP or regulated production environment
  • 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
PET Principal Engineer (advancement to this level is contingent upon development of significant expertise in one or more technical disciplines or assumption of leadership responsibilities based on business need)
  • Proven experience in GMP or regulated production environment
  • Expertise in two more of the following discipline equipment, process/materials, maintenance, project delivery
  • Site expert in a specific area applicable to multiple PETs or Facilities Management or ability to provide work direction to team members
  • Demonstrated leadership skills 
Preferred Background PET Senior Engineer
  • 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 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 
PET Principal Engineer
  • Mechanical/technical experience in more than one discipline
  • Proven ability to develop team dynamics as well as personnel
  • Proven ability to work with all levels within the organization -- locally and globally
Leadership Capabilities PET Engineer
  • Passion for customers
  • Drives performance
  • Act decisively
PET Senior Engineer
  • Passion for customers
  • Drives performance
  • Thinks Strategically
PET Principal Engineer
  • Develops People and Organization
  • Drives performance
  • Thinks Strategically
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation Location DE, Newark Category Manufacturing and Production Date Posted 6/17/2013 Req Number 14-10056587 Special Notes This position will be filled at a Band D or Band E based into the selected candidates experience. NoticeAstraZeneca does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on AstraZeneca's approved agency list. Unsolicited resumes or candidate information submitted to AstraZeneca by search/recruiting agencies not already on AstraZeneca's approved agency list, and who were not asked to work on a specific vacancy, shall become the property of AstraZeneca and if the candidate is subsequently hired by AstraZeneca, AstraZeneca shall not owe any fee to the submitting agency.   AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit www.astrazeneca.com.   AstraZeneca
Making a Difference
AstraZeneca is an equal opportunity employer   Refer A Friend Apply Now