Principal Engineer - Pharmaceutical Technology and Development - West Chester, OH | Biospace
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Principal Engineer - Pharmaceutical Technology and Development

AstraZeneca Pharmaceuticals LP

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Location:
West Chester, OH
Posted Date:
2/19/2017
Position Type:
Full time
Job Code:
R-002779
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

                             
                                       Location:West Chester, Ohio, United States
Job reference: R-002779

Posted date: Feb. 14, 2017



 

   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 Principal Engineer, Pharmaceutical Technology & Development in West Chester, OH, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.  

   As the Principal Engineer(PE) you will be primarily responsible for the PT&D pilot plant and lab facilities, projects and studies. The PE will expertly perform and lead activities related to the engineering support for complex process improvements, major deviation resolution, and new process transfers. The PE will work closely w/ PT&D colleagues and site leadersip, including global technical leaders, quality, and operations to evaluate product, process and equipment immprovement opportunities.  

 

   Major Responsibilities:  

 
       
  •      Second line technical expertise to aid the resolution of manufacturing/supply issues.    
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  •      The provision of product technical expertise to Operations Supply to drive continuous improvement and value for AZ.    
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  •      Identify and deliver continuous improvement initiatives for the established products.    
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  •      Develop and lead installation of new processes, technologies, and production equipment through specification development, and vendor activities prior to and during installation, commissioning and qualification.    
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  •      Organize and interpret process data for technical reports, regulatory agency submissions, and audits. Author key development / process control sections for submissions; participate in audits as a technical SME as needed.    
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  •      Secure and manage product knowledge throughout the lifecycle.    
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  •      Oversight of the drug product control strategy throughout the lifecycle.    
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  •      Lead and coordinate development studies.    
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  •      Provide high level leadership and direction for all activities in the pilot plant.    
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  •      Perform pilot scale manufacturing.    
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   Other Duties  

 
       
  •      Provide leadership, development, and mentoring for others.    
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  •      Be an excellent communicator with strong interpersonal skills in order to collaborate effectively with stakeholders globally.    
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  •      Analyze trends in data in order to provide accurate descriptions, identify root causes, and/or identify solutions or improvements.    
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  •      Monitor key performance indicators via appropriate dash-boards/CPV assessments to meet strategic goals.    
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  •      Ability to draw upon a range of influencing skills to arrive at the best outcome for AZ.    
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  •      The ability to produce novel ideas, to generate options which provide unique    
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  •      ways of looking at things and to identify problems, suggest new solutions and make improvements to the benefit of AZ.    
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  •      Read, understand, and follow SOPs (Standard Operating Procedures) and excerpts from technical documentation.    
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  •      Complete required training.    
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  •      Ensure proper documentation practices during job activities.    
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  •      Conduct troubleshooting activities.    
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  •      Attend inter-departmental meetings to discuss matters involving the coordination of multiple departments.    
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  •      Coordinate with representatives from other departments.    
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  •      Participate in cross-functional teams to meet strategic goals.    
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  •      Wear gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activities.    
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  •      Conduct safety checks for work group, department, or site.    
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  •      Consult cross-functionally as an SME (Subject Matter Expert) on systems and/or processes.    
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  •      Use SAP to track inventory and materials.    
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  •      Guide others on SOPs (Standard Operating Procedures), control documents, and/or other work instructions.    
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  •      Develop lean processes and procedures.    
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Requirements

   Essential Requirements:  

 
       
  •      Bachelor’s degree, engineering or technical field    
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  •      5 years experience in relevant roles in the pharmaceutical industry and/or operations environment    
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  •      Strong analytical skills    
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  •      Strong leadership, interpersonal, influencing and communication skills    
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  •      Knowledge and understanding of current Good Manufacturing Practices (cGMPs)    
  •  
 

   Desirable Requirements:  

 
       
  •      Previous experience in a Lean, process-centric organization with emphasis on continuous improvement    
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  •      Multi-site/multifunctional experience    
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  •      10+ years relevant experience    
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   Internal/External Contacts & Customers:  

 
       
  •      Process Execution Team Leaders, Technical Managers, Engineers, and Validation SMEs    
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  •      Proactive engagement with key stakeholders to ensure world class customer relations are maintained. For example regional quality & supply VPs, Site GMs etc.    
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  •      Global AZ technology community (Work in collaboration with global Product Development and the Manufacturing Science & Technology organization).    
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   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.

 

   ~bsp