Scientist, Metrology Specialist - Durham, NC - Global Operations
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 Scientist, Metrology in Durham, NC, 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
The Scientist, Metrology will be responsible for leading the site metrology activities for large and small scale manufacturing equipment. This position is responsible for drafting maintenance, operation and calibration documents to support the business need. This position will also be responsible for providing input in instrumentation for purchase based on user and manufacturer specifications and site needs. Coordinate vendor testing activities to ensure compliance with site and regulatory standards. Respiratory products experience preferred.
Duties and Responsibilities:
- Provide leadership and guidance in the area of metrology for manufacturing equipment
- Oversee asset management database and ensure assets are assigned asset identification labels per appropriate SOPs
- Provide expertise in developing maintenance and calibration programs for new assets as needed to support the business
- Oversee and perform calibration and maintenance activities for the site equipment and ensure activities meet current regulatory and company requirements
- Review vendor documentation for completeness and compliance with Good Documentation Practice SOP
- Receive quotations and complete purchase requisitions for calibration and maintenance services, and service agreements
- Manage service agreements with equipment vendors
- Provide first line troubleshooting support for equipment
- Provide technical expertise during equipment investigations
- Provide expertise in asset management and support implementation, maintenance and testing of the asset management software
- Bachelor's degree in Science or Engineering Degree OR
- Associates degree in a relevant technical discipline and a minimum of five (5) years of Pharmaceutical experience OR
- High School degree with work experience to include a minimum of seven (7) years of GMP, metrology or manufacturing experience required in lieu of a Bachelor's degree.
- Metrology experience with manufacturing, process, facilities and safety equipment is required.
- Technical ability to problem solve and maintain equipment in a pharmaceutical environment is required.
- In-depth understanding of relevant ICH, USP, EP, and FDA guidance documents, as well as cGXPs in support of metrology activities in a pharmaceutical manufacturing facility, is required
- Must be able to effectively communicate verbally and through technical writing (documentation of laboratory experiments) required
- Strong collaboration skills required
- Demonstrated success collaborating and working successfully in a multi-cultural, complex matrix environment required
Must be able to operate a PC and sit for extended periods of time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Expertise with asset management software in the pharmaceutical industry preferred
Experience with the use of Simco or similar software for asset management preferred
Strong leadership skills are preferred
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 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 authorisation and employment eligibility verification requirements.