Terumo BCT Engineer 2 - Process Validation in Lakewood, Colorado

Engineer 2 - Process ValidationDate: Jan 8, 2019Location:Lakewood, CO, US Company: Terumo BCT, Inc.Requisition ID: 22881JOB SUMMARYThis is an engineering role on the Process Validation team. This position isresponsible for validation activities for automated manufacturing processesand test methods. Work will involve assessing product and process risk(s)and understanding equipment and process parameters, writing, executing andreviewing protocols and reports and ensuring the validation of manufacturingprocesses are compliant with applicable internal procedures and externalstandaESSENTIAL DUTIESDesign, execution, analysis and approval of manufacturing IQ, OQ and PQprotocols and reports.Provides specification, procurement, installation, start-up, andcommissioning activities for manufacturing equipment, facilities areas,and process utilities systems.Manages projects including development of project scope and estimates,initiation of requests for capital when required, specification of equipmentand installation requirements, management of costs to budget, and supportof IQ/OQ and final documentation in accordance with acceptable engineeringpracConducts studies and makes recommendations for the purchase and implementationof new technologies, practices, tools, and equipment to maximize siteeffectiveness.Prepares, reviews and approves engineering and technical documents such asreports, SOP's, protocols, schedules and budgets, and vendorprovided documents and drawings.Ensures that process and equipment designs are compliant with all Companypolicies and procedures as well as all Local, State, and Federaldirectives, laws and regulations.Provides work direction to engineering support staff.Takes initiative and demonstrates inquisitive approaches to solve moderatelycomplex problems, indentifying problems, generating alternatives andrecommending solutions.Follows department processes and regularly makes recommendations on theseprocesses.Follows technical specification requirements, developing reports, chartsand graphs to support project recommendations and responds to questions fromtechnical staff members and management.Works cooperatively and effectively in a team environment or across teams toachieve common goals and results.Analyzes data and presents it in appropriate forums.Actively participates in Quality System and Good Laboratory Practicerequirements, particularly with respect to documentation.OTHER DUTIES AND RESPONSIBILITIESWork assignments may require additional development and a maturing orbroadening of in-depth engineering skill(s).May work with manufacturing and other functional groups on manufacturing andregulatory compliance issues.MINIMUM QUALIFICATION REQUIREMENTSEducationBachelor's degree or equivalent of education and experience sufficient tosuccessfully perform the essential functions of the job may be considered.Bachelor of Science Degree in Engineering, preferred.ExperienceMinimum 2 years experience.Two years of GMP manufacturing experience required.SkillsRequires demonstrated skills in technical innovation, technicalleadership, mechanical and or chemical engineering, fluids engineering,and cellular biology.Requires interactive skills in cross-functional participation and influence,mentoring and acceptance of guidance, technical leadership, projectmanagement, coordination with cross-functional team members, teambehavior, provides support for subordinates, junior engineers,technicians, and management.Mechanical and electronic ability and aptitude to assist with equipmenttrouble-shooting.Interfaces with staff, suppliers, and external subject matter experts toresolve technical issues and train and provide work direction to operators andproduction service technicians.Understanding of and adherence to GMP practices and FDA regulations.Knowledge and ability to implement FDA or regulatory requirements asnecessary.Demonstrated ability to communicate effectively both verbally and in writing.Knowledge and use of relevant PC so