Purpose and Scope
The Project/Equipment Engineer reports to the Principal Engineer and is responsible for scoping and executing technical projects in the vial filling area.
Responsibilities:
* Project management and execution of assigned projects.
* Working with various stakeholders, to scope projects and ensure requirements are satisfied.
* Supporting the introduction of new processes & products including problem solving and on the floor troubleshooting equipment issues.
* Development and implementation of maintenance programs and spare parts inventory optimization.
* Development and management of change controls.
* Participate as a member of multidisciplinary team.
* 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.
Collaboration and Communication:
* 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.
Qualifications:
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.
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