About Astellas:
At Astellas we are making treatments that matter to people.
We are tackling the toughest health challenges putting the patient at the heart of every move we make.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
We have developed ground-breaking, innovative medicines in immunology, oncology and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked.
We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients’ lives.
From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners.
The Opportunity:
The Systems Engineering Lead role is responsible for overseeing the daily operations of the systems engineering team, ensuring that the Tralee Plant operations are supported through the provision of fully autonomous systems across Operations, Engineering and Quality. This role involves managing a team of systems engineering staff and outsourced service providers, coordinating activities, and implementing policies and procedures to enhance operational efficiency. The role is also responsible for maintaining regulatory compliance for all relevant systems, GMP and Non-GMP. Systems under the scope of the team will ensure integration to both upstream and downstream systems such as Filling Line, Utilities, MES, Data Historian, lab instruments, automated guided vehicles connectivity’s and operation.
The position will be responsible for managing, coaching and developing all aspects of these functions with input and local accountability for strategy, forward planning, safety, quality, delivery, cost and service performance.
Responsibilities:
• Leadership & People Development: Lead the Systems Engineering team with clear ownership and accountability; develop future leaders, SMEs and high-performing teams through coaching, feedback and stretch objectives while fostering an engaged, high-trust culture.
• Organisational & Cross-Functional Excellence: Build a best-practice engineering organisation with strong infrastructure, skills and systems; promote innovation, psychological safety and Astellas values; collaborate effectively across functions, global partners and deputise for the Head of Engineering & QC when required.
• Operational Performance & Delivery: Deliver engineering and service objectives ensuring stable supply; manage multiple projects and priorities, resolve issues, drive continuous improvement, set ambitious targets and monitor KPIs and action plans.
• Compliance & Governance: Ensure full compliance with corporate policies, GMP/GDP, environmental and safety regulations; maintain audit readiness, deliver successful audits and ensure accurate, timely reporting.
• Strategic Alignment & Asset Capability: Contribute to site and global strategy, deliver strategic projects on aggressive timelines and within budget; maintain awareness of industry trends and enhance asset capabilities to support current and future manufacturing needs.
• Technology, Change & Business Continuity: Lead implementation of new technologies, systems and portfolio changes; retain and transfer critical technical knowledge, manage risk and crisis response, support business continuity planning and ensure readiness for future growth.
Education:
• Bachelor’s degree (or equivalent) in technology or computer science or proven relevant in-depth experience.
Preferred Experience:
• Experience & Technical Expertise: Extensive experience in a similar role (cGMP start-up experience advantageous) with strong technical competence in automation and systems, and a commitment to continuous professional development and improvement.
• Project & Delivery Capability: Proven ability to independently deliver multiple technical projects, provide process engineering design, commissioning, implementation and maintenance support in a cGMP manufacturing environment, and contribute to or lead cross-functional teams.
• Personal Effectiveness & Adaptability: Excellent organisational and communication skills, able to prioritise and adapt to changing needs, work effectively both independently and collaboratively, and remain open to new ideas and approaches.
Additional information:
• This is a permanent full-time position
• Position is based in Tralee – Ireland
• This position requires you to be 100% on site / in the office
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
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