GMP HVAC

Other relevant utility system experience includes:

• Clean Utilities (WFI, Clean Steam, Purified Water, Process Air, Nitrogen)
• Other Utilities (Glycol, Non GMP HVAC, Instrument Air, Water Systems [e.g. Service, chilled, potable, LPHW], Process Waste)
• Controlled temperature Units including fridges, and freezers.
• Associated qualified and non-qualified control systems
• This includes commissioning and qualification of new equipment and upgrades.

Responsibilities

• 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 operation
• Coordinating the introduction of new processes, equipment and materials including problem solving and troubleshooting equipment issues prior to qualification & start-up
• Supporting the development and implementation of maintenance programs and spare parts inventory optimization within scope of project delivery.
• 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 Teams structure and contributes to Root Cause Investigations and Cross Functional Investigations.
• Work 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

Qualifications:

• Bachelor’s Degree in Engineering or Relevant Experience
• Typically, 3+ years engineering experience, preferably within a GMP manufacturing environment.
• Proven project management experience.
• Strong mechanical capability with hands on experience in a technical role within similar areas.
• 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

PURPOSE

The Utility Project Engineer reports to the Senior Manager for Strategic Engineering Projects and is responsible for scoping and executing technical projects in utility areas supporting all areas of the facility. Specific advantage in having relevant experience in the following systems:

• Controlled temperature Units including walk in coldrooms

Responsibilities

• 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 operation
• Coordinating the introduction of new processes, equipment and materials including problem solving and troubleshooting equipment issues prior to qualification & start-up
• Supporting the development and implementation of maintenance programs and spare parts inventory optimization within scope of project delivery.
• 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 Teams structure and contributes to Root Cause Investigations and Cross Functional Investigations.
• Work 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 project