Senior PET Engineer-Packaging

5 - 7 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 08/18/17
Newark, DE
5 - 7 years experience
Salary depends on experience
Posted on 08/18/17

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As a Senior PET Engineer-Packaging 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.

Main Duties and Responsibilities

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 SAPmaster 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

Essential Requirements

  • Minimum 5years 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, appliedstatistics, mechanics, hydraulics, pneumatics, vacuum technology, electronics, programmable logic controllers, refrigeration, freeze drying, test equipment for electrical and mechanical trouble shooting, HVAC
  • 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)

Desirable Requirements

  • 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


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