AstraZeneca Pharmaceuticals LP Formulation Engineer - Newark, DE - Global Operations in Newark, Delaware

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost 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.

The Formulation Engineer will be 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

Education, Qualifications, Skills and Experience:

  • BS in Engineering, pharmacy or related science

  • 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)

Preferred Background:

  • 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

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. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.