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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 Sr. Project / Equipment 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.
Job Responsibility:
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 project prioritization, resources management, status management and external communication
Working with various stakeholders, to scope projects and ensure requirements are satisfied. Project input will span from concept, through design, construction, commissioning and commercial operational readiness
Development and implementation of maintenance programs and spare parts inventory optimization with the introduction of new equipment
Ability to 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
Work in a collaborative manner within the Process Teams structure and contributes to Root Cause Investigations and Cross Functional Investigations
Works in a collaborative manner with the System Owners, Maintenance Supervisors & Technicians, Capital Project Engineers and Vendors to perform equipment upgrade and/or retrofits
Perform all tasks with due care and attention ensuring 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
Requirements:
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 with hands on experience in a technical role within a high-volume manufacturing environment, is 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
Nice to have:
Technology transfer experience preferred
Strong mechanical capability with hands on experience in a technical role within a high-volume manufacturing environment, is advantageous
What we offer:
Competitive salary structure
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