Sr. Project Equipment Engineer – Amgen
Amgen Dun Laoghaire (ADL) is looking for a Sr. Project / Equipment Engineer to join our facilities & engineering team to support the continued expansion of the plant and production capability on site.
The engineer will report to the Associate Director for Facilities & Engineering and is responsible for portfolio ownership, scoping, and executing technical projects within Formulation, Component Preparation, Vial/Syringe Filling, Lyophilisation and Inspection areas. This includes new product introductions, qualification of new equipment and implementation of associated reliability and maintenance programs.
Key Responsibilities
Portfolio ownership of a number of projects within a specific business area supported by reporting engineers for successful completion.
Coordinating the introduction of new processes, equipment and materials including problem solving and troubleshooting equipment issues prior to qualification & start-up.
Coordination of engineering readiness scoping and readiness for new product introductions.
Project management and execution of assigned projects including prioritization, resources management, status management and external communication.
Working with various stakeholders to scope projects and ensure requirements are satisfied across concept, design, construction, commissioning and commercial operational readiness.
Development and implementation of maintenance programs and spare parts inventory optimization with introduction of new equipment.
Translate strategic/emerging technology solutions into pragmatic executable plans.
Development and management of change controls.
Participate as a member of multidisciplinary site and multisite teams.
Development of detailed specifications, engineering documents, protocols and standard operating procedures.
Collaborate within the Process Teams structure and contribute to Root Cause Investigations and Cross Functional Investigations.
Work with System Owners, Maintenance Supervisors & Technicians, Capital Project Engineers and Vendors to perform equipment upgrade and/or retrofits.
Ensure compliance with Good Manufacturing Practices and company requirements, policies and procedures.
Support a safe working environment by complying with environmental health/safety practice, rules and regulations.
Travel may be required to support execution of projects.
What We Expect of You
Bachelor’s degree in engineering (Mechanical, Electrical or Chemical) or relevant experience.
Typically, 5+ years’ engineering experience, preferably in the biotechnology industry/aseptic pharmaceutical environment or Automated Inspection and/or Automated Device Assembly, Labelling and Ancillary processes.
Technology transfer experience preferred.
Proven project management experience.
Strong mechanical capability and hands on experience in a technical role within a high-volume manufacturing environment, advantageous.
Demonstrated experience in a GDP compliant environment.
Experience in MS Office, MS Project, Change Control & Document Management Systems.
Proven ability working cross-functionally, delivering technical solutions and implementing improvements.
Solid leadership skillset and experience working in a team environment, embracing an interdependent working culture that delivers results.
Technical report writing and communication/presentation skills.
Data-driven decision maker.
Ability to work to tight deadlines in a fast-moving environment.
What You Can Expect of Us
In addition to a competitive salary structure, Amgen offers a generous Total Rewards Plan for staff and eligible dependents. Comprehensive employee benefits package, including retirement and savings plan with generous company contributions, group medical, life and disability insurance. Discretionary annual bonus program. Exceptional learning, development and career advancement opportunities, empowering employees to grow and build long-term careers. At Amgen, we are committed to nurturing talent and providing meaningful pathways for professional development.
Amgen is an equal opportunities employer.
Location: Dublin, County Dublin, Ireland
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