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Acara Solutions Product Development Engineer 2 in Lakewood, Colorado

Acara Solutions is assisting one of our top clients in the Denver, Coloradoarea to fill the role of Product Development Engineer 2 within their team.Candidates must have 2+ years experience working in a GMP environment, andprevious Medical Device experience is a plus.JOB SUMMARYWork requires independent evaluation, selection and application of standardengineering techniques, procedures, and criteria, using judgment andingenuity in making minor adaptations and modifications. Assignments includeequipment design and development, tests of materials, preparation ofspecifications, process study, research investigations, reportpreparation and other activities of limited scope. Duties are assigned toprovide experience and familiarization with engineering methods, independentthinking, and company practices and policies.ESSENTIAL DUTIESProvides 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 and reviews engineering/technical documents such as reports,SOP's, protocols, schedules and budgets, and vendor provided documentsand 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 require