Sr. Principal Engineer - Bioprocess

Sr. Principal Engineer - Bioprocess page is loaded## Sr. Principal Engineer - Bioprocess locations:
US, Richmond VAtime type:
Full time posted on:
Posted Todayjob requisition :
R-101462

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first.

We’re looking for people who are determined to make life better for people around the world.
* Lilly is currently constructing an advanced manufacturing facility for monoclonal antibodies, bioconjugates, and aseptic drug product manufacturing in Goochland County, Virginia. This facility is intended to provide capacity for current and future products.  This is a unique opportunity to be a part of the leadership team for the startup of a manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.
* ** Responsibilities:
** We are seeking a Sr. Principal Bioprocess Engineer to support our new Manufacturing Facility in Goochland County, Virginia. Process Engineering is core to delivering a right first-time facility start up and continued support of ongoing manufacturing operations into the future.

Some key responsibilities of the role include;
** Facility Start-Up Phase;
*** Provide Process Engineering support to the Global Facility Delivery team (Lilly’s Global Large Scale Capital Delivery Team) with a strong focus on right first time and on schedule facility start-up (e.g. design reviews, process safety assessments, User Requirements, C&Q support, Unit Operation Shakedown, Facility Run Rate Readiness)
* Define and own relevant aspects of the overall integrated Operational Readiness Plan (e.g. SOP development, maintenance strategy, automation optimization, run rate readiness, MES E  requirements, alarm requirements, Performance Qualification Study Requirements / Protocol Development etc.)
* Own the Performance Qualification strategy and execution for area of responsibility
* Support initial Operations Training requirements as the Equipment and Area SME
* Lead/support the tech transfer of new processes into the facility
** Post facility start-up phase;
*** Provide process engineering support through application of process engineering fundamentals
* Identify and implement continuous improvement opportunities related to equipment and processes as core member of cross-functional process team.
* Utilise root cause analysis techniques to investigate process and equipment issues and deliver robust and sustainable corrective and preventative actions
* Monitor, assess and document equipment performance to maintain ongoing qualification.
* Develop and maintain the basis of safety for process equipment
* Develop and implement unit operation and equipment control strategy
** Basic Qualifications
*** Bachelor's Degree in Process, Chemical, Biochemical Engineering or related applicable discipline
* 7+ years of process team experience in pharmaceutical manufacturing, preferably monoclonal antibody manufacturing
* Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1
** Additional Preferences
*** Deep technical interest and understanding in the field of monoclonal antibody manufacturing and Bioprocess Engineering.
* Strong analytical and problem-solving skills.
* Ability to work on own initiative and as part of a Process Team consisting of a diverse group of management, production, science, quality and engineering professionals.
* Creativity to identify improvement opportunities and the tenacity/initiative to see them implemented.
* Guidance/mentoring of others through…