Skip Navigation

Job Title

Job category

Science

Search jobs by matching your skills with LinkedIn

Sign up for job alerts

Or search again

Search by city

Location:
Philadelphia, Pennsylvania, United States
Job reference: R-045402
Posted date: Apr. 10, 2019
Apply

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 / Senior Engineer - Packaging and Formulation in Philadelphia, PA, 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. 


This role will be hired at either an Engineer or Senior Engineer level based on the experiences and qualifications of the successful candidate.  This is a first-shift role.


The Engineer / Senior Engineer - Packaging and Formulation is responsible for the technical process within the Manufacturing Department. This includes equipment, materials and procedures; overall life cycle management. Leads projects and improvement initiatives as the technical expert.


Major Responsibilities

  • Ensures there are technical processes with center-lines, 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, various lean initiatives, 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 Manufacturing/Facility process.
  • Deliver or support the Manufacturing 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, URS, RID’s, system impact assessments, risk assessments, 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 the Manufacturing and Engineering Community (local, regional, global).
  • Supports technical trouble shooting (ie above line technical support) and provides technical support presence to off shifts as needed.
  • Process Owner/SME for regulatory inspections and audits.
  • Provides input 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.).
  • As  business  needs  dictate,  requirement  to work  second,  third  and  weekend  shifts to ensure full   coverage/oversight  for  the  team  and  to  engage  all  personnel  in  product  launches,  continuous improvement, system ownership,  site  shutdown  activities,  and  self-directed  mechanic  and technician  work  team  activities.


Qualifications:


Education:

  • BS in Engineering or related science degree

Engineer Level Requirements:

  • Minimum two (2) 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.
  • 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)


Sr. Engineer Level Requirements:

  • Minimum 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 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)
  • 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


Preferred:

  • 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

Apply
Senior Engineer - Packaging & Formulation - Philadelphia, PA - Global Operations
Engineering

Sign up for job alerts

If you would like to sign up for email job alerts for future roles with AstraZeneca or MedImmune you can do so using the form below. We will only use the details you provide below to inform you about future vacancies that match your search criteria if and when they become available. The details you provide on this page will not be used to send unsolicited communication and will not be sold to a third party.

 

You can select as many categories and locations as you wish.

Interested InSelect a job category from the list of options. Search for a location and select one from the list of suggestions. Finally, click “Add” to create your job alert.

  • Engineering, Philadelphia, Pennsylvania, United StatesRemove
  • Global Operations, Philadelphia, Pennsylvania, United StatesRemove