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Senior Engineer | Engineer in Engineering Job at Bioduro in Irvine CA | 6215291674

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Senior Engineer

Irvine, CA

Job Title: Senior Engineer Department: Facilities Reporting To: Maintenance Engineering Supervisor Classification: Exempt What We Do BioDuro-Sundia is one of the premier Contract Research, Development and Manufacturing Organizations (CRDMO) globally, with more than 2,200 employees. Our US operations are US headquartered in San Diego, CA. Our 10 facilities provide integrated solutions and exceptional services to our clientele for challenging preclinical and clinical trial projects . With capabilities spanning Drug Discovery, Development, and Manufacturing, it is no surprise that BioDuro-Sundia is a leading partner of choice. Why BioDuro-Sundia? Take the next step in your career and join BioDuro-Sundia today to change lives through the products we help create. Here, you will contribute your talents to meaningful projects that impact the lives of patients around the world and develop as an individual by working directly with a team of seasoned experts and rising stars. Our values of Accountability, Respect, Tenacity, Results and Integrity are embedded in everything we do. No matter what your role may be, BioDuro-Sundia strives to ensure all our employees are empowered and given the necessary tools to lead us in our relentless pursuit of success. Job Overview/Summary The Senior Engineer evaluates existing processes and manufacturing/packaging systems to reduce cost, improve sustainability and develop best practices within the production process. The Sr. Engineer implements system improvements and capital projects; establishes engineering project goals and objectives and technical criteria; develops work and equipment processes that lead to shortened cycle time; supports the policies, goals and company objectives. Leads and participates in planning and conducting work requiring judgment in the independent evaluation, selection and substantial adaptation and modification of standard techniques, procedures and criteria within engineering specialty. Performs work which has limited number of complex variables. Devises new approaches to problems encountered. Essential Functions and Responsibilities Improves process capability and production volume while maintaining and improving quality standards. Prepares reports, analyzes data, and makes recommendations for improving plant operations and solving manufacturing/packaging-related problems. Develops and implements systems that optimize all phases of manufacturing/packaging process. Routinely has direct contact with outside consultants and technical counterparts from key vendors. Evaluates and improves processes in manufacturing systems. Supports maintenance and operations staff in reviewing the operations of plant equipment and systems to minimize unplanned downtime, anticipate solve problems in a timely manner, and identify opportunities for improvement. Works with equipment designers and manufacturing/packaging teams to develop a cost-effective and working production process. Assists with planning and implementing plant improvements and expansions. Manages capital projects or process improvement initiatives, as required, to deliver within schedule and budget. Scopes and carries out projects that improve efficiency and/or reduce operating costs. Develops project schedules and budgets as required. Coordinates activities with manufacturing, packaging, logistics, research and development, technical services and IT Departments. Communicates regularly with all engineers, both individually and as a group, to ensure effective two-way communication concerning operational improvements and projects. Coordinates with outside consultants, contractors/vendors brought in to support design and/or project implementation. Prepares, reviews, and executes commissioning/qualification/validation/ verification protocol documentation, as required, to support the implementation of manufacturing equipment/systems. Prepares additional project lifecycle support documentation (e.g. Basis of Design, Process Workflow diagrams, Validation Test Plans, User and Functional Requirements Specifications, Design Specifications, and Requirements Trace Matrix as required). This job description is subject to change at any time. Required Qualifications Bachelor of Science degree in Chemical, Mechanical, or Electrical Engineering or related studies required with 5+ years’ progressive technical experience OR MS with 3+ years’ experience as noted above. Previous experience in cGMP manufacturing environment. Pharmaceutical industry experience a plus. Experienced with 2D and 3D design software (e.g. AutoCAD, SolidWorks). Thorough knowledge of cGMP and FDA regulations. General understanding of Lean Manufacturing and Six Sigma principles. Expertise with Microsoft software (e.g. Word, Excel, Project, PowerPoint, Outlook, Visio). Must have the ability to work effectively with a computerized maintenance management system and instruct others on its operation. Able to establish and maintain cooperative working relationship with individuals contacted in the course of work. Able to understand and follow oral and written instructions. Able to communicate clearly and concisely, both oral and writing. Occasionally be required to climb or balance. Occasionally be required to lift and/or move up to 50 pounds. Occasionally exposed to outside weather conditions and risk of electrical shock. May be exposed to high noise environments. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Six Sigma certification a plus. Preferred Qualifications Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures. Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans. Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others. Judgment - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions. Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics. Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality. Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly. Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events. Position Benefits BioDuro-Sundia employment provides the opportunity to work in beautiful Irvine, California. We offer full health benefits, paid vacation and sick leave, an aggressive bonus structure, and market-competitive salaries to all our employees. In addition, BioDuro-Sundia provides a variety of engaging employee and community outreach events. We strive to reward and promote employees who exhibit our values of Accountability, Respect, Tenacity, Results and Integrity. EOE and Accommodation We value diversity and are proud to be an Equal Opportunity and Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law. BioDuro-Sundia provides reasonable accommodation in job application procedures for qualified individuals with disabilities and disabled veterans. If you need accommodation in connection with the recruiting process due to a disability, you may use the alternative methods by emailing If you are selected to interview for a position, you may also request an accommodation with our team directly. Notice to Agency and Search Firm Representatives BioDuro-Sundia is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any BioDuro-Sundia employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of BioDuro-Sundia. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Powered by JazzHR
September 20 on The Resumator
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Senior Engineer is a Engineering Engineer Job at Bioduro located in Irvine CA. Find other listings like Senior Engineer by searching Oodle for Engineering Engineer Jobs.