1. Develop and manage execution of small to medium-scale projects including timelines and financial allocations with minimal supervision. Able to identify and resolve design or schedule conflicts during project/task execution.
2. Design equipment and processes to meet end-user/owner, site, global and cGMP requirements. This includes the creation of scoping and vendor proposals for bidding purposes.
3. Lead multi-discipline and multi-department project Teams.
4. Able to communicate project resource needs. Allocates assigned engineering resources to achieve project timelines and budget expectations.
5. Ability to execute multiple projects concurrently.
6. Provide capital oversight to projects lead by others outside of the Engineering group.
7. Adhere to cGMP requirements, CSL procedures and design specifications/standards during project execution.
8. Research and develop technical engineering and design standards/specifications.
9. Provide reporting to department, site and corporate organizations as required.
10. Able to develop, execute and close-out project documentation such as change controls, factory acceptance testing, site acceptance testing and commissioning protocols, installation and operation qualifications and system specifications.
11. Support on-going manufacturing needs when required.
12. Supports the facility in internal and external inspections.
13. Other tasks as required by Department Management.
Education: BS Chemical, Mechanical or Electrical Engineering. In lieu of an Engineering degree, technical experience in a pharmaceutical or regulated industry may be considered.
Experience: 4+ years of technical experience with 3 to 5 years in pharma preferred with an Engineering degree in any of the above disciplines. In lieu, proven ability to perform in this role will be considered (such as on-site contract/consultant experience).
Action Oriented, Problem Solving, Learning on the Fly, Technical Learning, Time Management, Prioritizing, Oral and Written Communications
Worker Sub Type:Regular