Equipment Engineer

Desired Skills: Engineering Projects,Equipment Engineering,Project Management,Drug Product Manufacturing,Change Controls,GMP

Onsite frequency: Primarily onsite with flexibility for some remote work.

Job Description

The Project / Equipment Engineer reports to the Senior Manager for Engineering Projects and is responsible for scoping and delivering technical projects that support Drug Product manufacturing. The role focuses primarily on the Lyophilisation area, with additional responsibilities across Formulation, Component Preparation, Vial/Syringe Filling, and Inspection. Key responsibilities include the introduction and qualification of new or upgraded equipment, along with the implementation of associated reliability and maintenance programs.

Key Responsibilities

• Project management and execution of assigned projects including project prioritization, resources management, status management and external communication.
• Acting on behalf of the sustaining system owners to ensure the robust and effective delivery of project elements to the end user.
• Working with various stakeholders, to scope projects and ensure requirements are satisfied. Project input will span from concept, through design, construction, commissioning and operation
• Coordinating the introduction of new processes, equipment and materials including problem solving and troubleshooting equipment issues prior to qualification & start-up
• Development and implementation of maintenance programs and spare parts inventory optimization with the introduction of new equipment.
• 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 (e.g. FAT)

Experience and Qualification:

• Bachelor’s Degree in Engineering (Mechanical, Electrical or Chemical) or Relevant Experience
• Typically, 3+ years engineering experience, preferably in a GMP biopharmaceutical manufacturing environment.
• Proven project management experience.
• Strong mechanical capability with hands on equipment experience in a technical role
• 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

Please click the link below to apply or alternatively send an up-to-date CV to howie.leahy@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***