The Project / Equipment Engineer reports
to the Senior Manager for Strategic Engineering Projects and is responsible for
scoping and executing technical projects supporting Drug Product manufacturing
within Formulation, Component Preparation, Vial/Syringe Filling,
Lyophilisation, Device Assembly, Inspection, Labelling and Packaging areas.
This includes qualification of new equipment and implementation of associated
reliability and maintenance programs.
• 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
• 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
• Participate as a member of
multidisciplinary site and multisite teams
• Development of detailed
specifications, engineering documents, protocols and standard operating
• 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
• Bachelor’s Degree in Engineering
(Mechanical, Electrical or Chemical) or Relevant Experience
• Typically, 3+ years engineering
experience, preferably in the biotechnology industry / aseptic pharmaceutical
environment or Automated Inspection and/or Automated Device Assembly, Labelling
and Ancillary processes.
• 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
• 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
• Data driven decision maker
• Ability to work to tight deadlines in
a fast-moving environment