Engineering Lead

Global Life Science Hub is excited to collaborate with a forward-thinking manufacturer that accelerates the path of specialised medicines to market. With a relentless focus on innovation, they are poised to significantly transform the landscape of CDMO practices.

Due to an incredibly large cash investment, they are now in a position to build a brand new scientific innovation hub in Ireland to enhance their global manufacturing capabilities which will create 500 new positions.

Having achieved remarkable milestones, we now seek an accomplished Engineering Lead who will play a pivotal role in spearheading the design of their brand-new GMP facility working cross-functionally with the design teams.

Position: Engineering Lead

Responsibilities:

• Lead the engineering team in the design, development, and implementation of the new GMP facility, ensuring alignment with company goals and regulatory requirements.
• Work closely with cross-functional teams including design, manufacturing, quality assurance, and regulatory affairs to ensure seamless integration of engineering solutions.
• Develop and execute strategic plans for engineering projects, ensuring alignment with overall business objectives and timelines.
• Manage resources effectively, including budget allocation, staffing, and equipment procurement, to ensure successful project execution.
• Provide technical expertise in engineering principles, GMP regulations, and industry best practices to drive innovation and efficiency in facility design and operation.
• Identify potential risks and develop mitigation strategies to ensure project success and compliance with regulatory standards.
• Collaborate with quality assurance teams to establish and maintain quality standards throughout the engineering process, ensuring compliance with GMP requirements.
• Drive continuous improvement initiatives to optimize processes, reduce costs, and enhance overall efficiency in facility design and operation.
• Collaborate with external vendors and contractors to source materials, equipment, and services necessary for project implementation, ensuring quality and cost-effectiveness.
• Maintain accurate documentation of engineering activities, including project plans, progress reports, and technical specifications, to ensure compliance with regulatory requirements and facilitate knowledge transfer.

Experience/Qualifications:

• Bachelor’s degree or higher in engineering, preferably in mechanical, chemical, or industrial engineering. Advanced degree or relevant certifications are a plus.
• Minimum of 7-10 years of experience in engineering leadership roles within the pharmaceutical or biotechnology industry, with a proven track record of successfully leading complex engineering projects.
• In-depth knowledge of GMP regulations and guidelines, with experience in designing and operating GMP-compliant facilities.
• Strong project management skills with the ability to effectively manage resources, timelines, and budgets to deliver projects on schedule and within budget.
• Familiarity with regulatory requirements relevant to pharmaceutical manufacturing, including FDA, EMA, and other international regulatory agencies.

Apply:

The Global Life Science Hub are a niche Life Science headhunting firm. We place professionals across Europe and the US for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations.

If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.glshub.com

GLS Hub