Process Engineer -Solution Preparation

What youwill do

In this vital role you will be joining the Facilities & Engineering (F&E) group to partner closely with the corporate engineering team tosupport thedesign, build, commissioning, and qualification ofnew equipment and systems needed for drug substance production as well as developing domain expertise tosupport operations upon start up, focusing onSolution Preparationprocess equipment.

Sitedesign,construction, start-up, and operational readiness:

• Participate in ongoing FATs as well as SATs and continuethat supportduring installation,commissioningand qualification activities ofSolution Preparationequipmentin alignment with GMP requirements.

• Ensure systems are installed and operatingsafetyandcomplywithpertinentenvironmental health/safetypractice,rulesand regulations.

• Support water runs, engineering runs, and process qualification activitiesforSolution Preparationequipment.

• Work withexistingplantteam, includingmanufacturing,engineering, andmaintenance, to support allmanufacturing and maintenance procedures, associated job plans, and applylessons learned to new plant.

Site Operations:

• Provide systemownership andsupportforSolution PreparationBiopharmaceutical process equipmenttypically used inbiologicsmanufacturing (e.g.Single-use Mixers,Downflow Boothes,Scales,StainlessPrep/Hold Vessels,CIP Skidsetc.)

• Assistinidentifyingand implementing engineering-based improvements or upgrades to equipmentand unit operationreliabilityby partnering with cross-functional teams.This may includedevelopment ofbusiness cases for improvements,identifyingdesign requirements, translating these requirements into process equipment/system design, specifications, and supporting the construction, startup, and validation of equipment.

• Execute master maintenance program (MMP)toensure the availability of spareparts andcoordinating maintenance activities to ensure systems are in proper working orderin partnership with OEMs.

• Provide technical support to troubleshoot,identifyand resolve process and system issues as needed.

• Provideproblem solving support to reduce production downtime. Thisincludessupporting technical root cause analysis and implementation of corrective/preventiveactions.

• Assistwithnew product/technology introductions by performing engineeringand facility fitassessments,implementing equipment modifications, and supporting engineering runs.

• Communicatewithsupervisorand support stafftohighlight issues and proposesolutions.

• Ensure24x7 day-to-dayreliabilityfor manufacturing operationsforSolution Preparationequipment.

• Participate in rotational on-call support onceplantis operational.

What we expectofyou

We are all different, yet we all use our unique contributions to serve patients. The engineering professional weseekenjoys challenges and is motivated to help serve patients with these qualifications.

Basic Qualifications:

• High School Diploma / GED and 10 years of Engineering experience OR

• Associate’s Degree and 8 years of Engineering experience OR

• Bachelor’s Degree and 4 years of Engineering experience OR

• Master’s Degree and 2 years of Engineering experience OR

• Doctorate Degree

Preferred Qualifications:

• Bachelor’s degree in Chemical or Mechanical Engineering.

• 6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment

• Direct knowledge of biopharmaceutical production facility with direct experience withSolution PreparationProduction(Single-use Mixers, Downflow Boothes, Scales, Stainless Prep/Hold Vessels, etc.), and CIP/SIPSkids.

• Ability to analyze problems, develop and propose engineering solutions in a scientificmanner using data-driven techniques and analyses (e.g., Data Analytics, Root CauseAnalysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)

• Experience working in a regulated environment (e.g.cGMP, OSHA, EPA, etc.) andfamiliarity with GMP quality systems/processes such as change control, non-conformances,corrective and preventative actions, and qualifications/validation

• Experience applying engineering principles to the design and implementation of systemmodifications, introduction of new processes, andsupportof capital projects.

• Understanding of capital projects in a GMP Biopharmaceutical Production facility includingprocurement, construction, startup, and validation

• Understanding ofsafety requirements working in a GMP Biopharmaceutical Productionfacility.

• Independent, ambitious, organized, able to multi-task in project environments, and skilled incommunication, facilitation, and teamwork

• Work schedule flexibility asrequiredto support 24/7 operations, requiring occasionalafterhoursengineering coverage