A career is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
An exciting and challenging opportunity for a Project Lead has become available at our Life Sciences Manufacturing Site in Livingston in Central Scotland. This is a new role to take full accountability for delivering a high-profile project introducing a new product to the site, with a direct reporting line to the Site Head of Operations. This is a terrific opportunity to demonstrate the knowledge & experience you’ve gained across the whole project lifecycle, bringing energy and a delivery focus to the team from early stages working with our R&D team into Technology Transfer, project managing the design, installation, commissioning and validation of new equipment to deliver the product, seeing the process through into full-scale production.
Key accountabilities for this role are:
- To effectively coordinate all activities within site project to ensure delivery on time and within budget.
- Ensure that adequate resource, roles and responsibilities and scope are clearly defined and understood for the length of the project.
- Provide regular project status update to all key stakeholders (Senior management, project sponsor and external parties) and provide reports as and when needed.
- Works effectively in a mixed environment and uses best practices and knowledge of internal or external business issues to improve products or services and to define processes and standards.
- Support the maintenance and execution of project work packets to ensure gates are completed in line with overall project timelines. This would be, but not limited to documentation preparation, supplier assessment, reaching out to key stakeholders.
- A detailed knowledge and understanding of Quality Management System, including deviation management, and change control within a highly regulated medical device environment.
- Provide validation guidance and expertise for investigation of failures and participate in CAPA, customer complaints and continuous improvement initiatives.
- Support the implementation of the project deliverables as it moves from design, development and manufacturing.
- Maintain on-going understanding and knowledge of the latest regulatory and quality requirements for compliance with EU/U.S. regulations and guidance documents.
Who you are:
- Bachelors/Undergraduate Degree in a quality or science related discipline (chemistry, biology, or medical technology preferred).
- A working knowledge of project management techniques (Prince 2, Agile etc)
- Five (5) years’ experience in a drug manufacturing, medical device, or biologics industry in Project Management, Quality Assurance or GMP manufacturing
- Previous experience should demonstrate expertise in, cGMP, FDA regulations, SOP development, as well as an understanding of Validation and Data Integrity Principles.
- Analytical and problem-solving skills, including presentation of results into meaningful reports
- Competent in the use IT technology, such as Microsoft Word, Excel and PowerPoint.
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfill your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
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