Job Description

Our Engineers support internal and external manufacturing operations to remain operational, continuously improve, and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation.

Essential Duties and Responsibilities:

Supporting development and execution of plans for laboratory start up, including equipment ordering, planning for testing, maintenance, calibration, and qualification. 

Supporting capital project execution teams for lab renovation projects to ensure project scope alignment with intended lab operational philosophy and lab scale platform needs 

Develop tools and schedules to aid process teams in the efficient utilization of lab space 

Customer focused mindset with the ability to communicate adequately (verbally/writing) to all levels within the organization.  

Make risk-driven technical decisions and initiate transformational initiatives 

Promote primarily the validation of computerized Analytical and or production systems as per System Development Life Cycle guidelines, updated CFR Data Integrity standards, and other regulatory guidelines. 

Partnering with the business unit in the laboratories, process manufacturing and development areas, various quality sponsored oversight, IT technical promotion, and various software and instrument vendors/manufacturers. 

Performing any change control during the life cycle of a computerized system. 

Decommission systems as part of the System Development Life Cycle (validation) guidance. 

Manage the capital purchasing and initial installation of computerized analytical systems prior to validation.