- Supporting Front End studies with containment technology selection, capacity calculations and preliminary equipment sizing.
- Successfully designing and delivering state-of-the-art, integrated containment and processing technologies which can be operated and maintained efficiently, in collaboration with equipment suppliers and engineering design and construction firms.
- Supporting process risk assessments (HAZOP, FMEA), System Impact Assessments and URS development and approval, to establish and deliver safe process operations and meet drug product quality requirements.
- Supporting procurement's strategic supplier management efforts, including establishing qualified suppliers and driving bid evaluations.
- Providing construction phase technical audits and leading GMP equipment testing and FAT's, including authorization to release equipment from supplier to AZ site.
- Providing technical support to GMP equipment commissioning and validation, including effective verification of required containment performance using industry standard methodologies
- Developing and implementing standard specifications for containment technology, where relevant.
- Providing AZ sites and external manufacturing partners with technical expertise to solve and or improve process operations.
- Detailed understanding of Containment terminology, what it means and the implications for equipment design.
- A solid understanding of Basic Toxicology to allow coherent conversations with specialists and to understand the reality behind quoted target values.
- A working knowledge of Industrial Hygiene general principles, including identification and evaluation of exposure routes, methods of exposure control, and exposure measurement.
- An understanding of ergonomic principles and Human Factors engineering to enable effective design of manually intensive systems such as isolators.
- A thorough understanding of the general principles of control (barrier, LEV, PPE) and details of individual engineered containment systems available (pros, cons, where to apply different solutions and the implications on other associated processes.
- Knowledge of the range of Containment equipment solutions, their functionality and operability, how to integrate them into process systems and available suppliers.
- Understanding of the project process, to know when to develop new/novel systems and when to go with established standard technology.
- Experience with capital project delivery from business case development through project execution, including the specification, procurement, installation, start up and commissioning of containment equipment in a licensed GMP commercial plant.
- Knowledge of risk assessment methodology and the effectiveness of maintenance and cleaning methods, and how they may mitigate potential exposure.
- Ability to collaborate across global functions and to actively engage with and communicate complex concepts to both internal and external collaborators, particularly SHE (hygienists and process safety), process operators, maintenance teams, project engineering teams, cleaning specialists and QA functions.
- Networked with other Containment experts to share learning and advice on installations and technology suppliers.
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Global Engineering - Macclesfield, United Kingdom - AstraZeneca
Description
Are you an expert in identifying and implementing Containment technology solutions to protect operators and pharmaceuticals in chemical and biologics manufacturing? Do you have a passion for designing and deploying optimal containment technologies into laboratory, development, and manufacturing facilities? If so, AstraZeneca is the place for you We are committed to delivering more medicines to patients, quicker and more affordably.
AstraZeneca's (GERE) team has its main hubs in the U.K., U.S. and Sweden, we also have a presence in Asia Pacific, Ireland and France. We are playing a fundamental role in supporting AstraZeneca's strong pipeline by establishing next-generation facilities. Combining the use of the newest technologies, skilled program management and a broad range of engineering and construction expertise, the team establishes positive relationships with end customers to build facilities which match requirements and exceed expectations.
If you have the passion and the drive to accelerate growth and make people's lives better – then this is the place for you.
Accountabilities:
As our Containment Subject Matter Expert (SME), you will be the technical point of reference for complex containment solutions for pharmaceutical chemical and biologics manufacturing projects. You'll be responsible for the selection, design, and startup of effective GMP containment technology and its performance, delivered to cost and schedule targets. You will have a direct impact selecting and integrating future containment technologies to enable safe and efficient manufacturing operations and deliver value to our patients. This requires a good understanding of how the safety requirements interface with corporate business goals and the ability to develop optimal technical solutions meet both needs.
You'll be supporting AstraZeneca's laboratory, development and manufacturing operations globally. Typical responsibilities include:
Essential Skills/Experience:
Collaboration is a way of life for us. The role can be based in Macclesfield (UK), Södertälje (Sweden), Wilmington or Gaithersburg (USA). As your expertise may be required for technical assessments at other facilities, you should be flexible to travel internationally accordingly. This will be discussed in more detail at interview stage.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Why AstraZeneca?
At AstraZeneca, we are driven by our commitment to deliver accelerated growth and to make people's lives better. We are constantly learning and seeking out new challenges, working towards new solutions. We are part of an inclusive and giving community, supporting and helping each other on our journeys. We are leading the way in delivering Lean processes that drive greater efficiency and speed. Sustainable practices are at the heart of what we do, ensuring we manage our environmental impact across all our activities and products. We have the ambition to be a performance-driven network, combining focused execution with a harmonious team-spirit.
Are you ready to make a positive impact on society through our sustainability goals? Are you ready to pioneer AstraZeneca's sustainability strategy and be a key contributor to Zero Carbon by 2025 and carbon negative across the entire value chain by 2030? If so, apply today and join us in making a difference
Date Posted
08-Apr-2024Closing Date
28-Apr-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
