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 Validation Engineer in Philadelphia, 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. Hear from our Senior Leaders about why they know AstraZeneca is a great place to work. https://lnkd.in/g8APibK

Performs installation, operational, and performance qualification (IQ/OQ/PQ) activities, under the mentorship of a senior validation engineer, for critical manufacturing equipment, facilities, and utility systems for the site. Performs IQ/OQ or re-validation activities for controlled temperature units (CTUs) with minimal supervision.  Provides technical support for formulation, filling and packaging activities including investigations and deviations from the validated state. 

Responsibilities include but not limited to:

• Write validation protocols and reports
• Perform validation activities described in validation protocols including thermal studies, cleaning, sterilization, shipping, computer systems, equipment and utilities qualification and/or validation
• Maintains an up-to-date knowledge of validation requirements, practices, and procedures
• Works with validation and metrology contractors when required
• Interacts with Manufacturing Science and Technology and Facilities / Engineering departments to facilitate protocol execution as necessary
• Communicate effectively with supervisor and other departments with respect to workload, priorities, and issues to maintain validation schedule
• Frequent use and application of technical standards, principles, theories, concepts, and techniques.
• Provides solutions to a variety of technical problems of moderate scope and complexity. 
• Works under general supervision.  Follows established procedures.  Work is reviewed for soundness of technical judgment, overall adequacy and accuracy.

Qualifications:

Education:

• Bachelors degree required:  Engineering or Technical Field Preferred

Required:

• Minimum of one (1) year of experience in validation. This may include internships /aggregate role.
• Good technical writing skills.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Desired:

• Proficiency in the use of the Kaye Validator or equivalent desirable.
• Experience with cleaning and sterilization validation desirable.

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.

Date Posted

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AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.