Advantage Resources is currently hiring a Manufacturing Engineer II to join our client in Santa Clara, CA!
The Manufacturing Engineer perform system analysis to propose and implement improvements to achieve capacity expansion goals.
- Maintain interface with Project Leadership to status project details as frequently as required; prepare detailed plans for all project phases.
- Provide innovative technical solutions required to meet business objectives with emphasis on increased capacity.
- Perform validation of equipment, automation systems, data collection systems, and processes for the manufacturing operations.
- Preparing protocols, perform testing, collect samples, analyzing test results, and preparing summaries.
- Provide technical assessment and validation review/approval for engineering and process changes.
- The Manufacturing Engineer II will apply engineering expertise in the coordination of multiple, sophisticated, non-routine projects involving the planning, design, reconfiguration, construction, and alteration of processes, systems or equipment.
Specific responsibilities include:
- Applying technical principles, theories, and concepts in the development of new principles and concepts, performing work that involves in-depth investigation of subject area.
- This position will independently provide engineering support for process and/or equipment upgrades, replacements, and modifications in manufacturing and manufacturing support environments.
- Requires the ability to troubleshoot systemic issues, develop, coordinate, analyze, and present interpretation of results regarding operational issues or Engineering projects, and apply sophisticated engineering principles to the design and implementation of new or modified system or processes.
- Requires solid understanding of engineering principles and practices that can be applied to a broad variety of assignments in related fields, to develop and apply creative technical solutions to sophisticated problems, and working with manufacturing, process development, engineering, analytical, and quality assurance staff to develop requirements and recommendations for large and/or highly complex processes and systems.
Minimum Qualifications (must haves) Education:
- BS/BA Engineering Degree any discipline or related proven experience.
- A minimum of 3 years of equipment selection experience in a cGMP environment with growing levels of responsibility for a wide range of projects, including design, validation, and operation of large scale manufacturing, and automation systems.
- Experienced with Lean approaches and tools (SMED, 5S, Kaizen, Value Stream Mapping, Kanban, more)Must be able to work independently as well as with teams, coordinate and manage projects by defining milestones, budgets and schedules; prepare regulatory summaries and present validation to regulatory authorities.
- Must have knowledge of manufacturing processes, quality systems, engineering design and start-up fundamentals, regulatory agency expectations and industry trends.
- Experience with regulated environments (i.e. cGMP, FDA, ISO 13485, OSHA, EPA) is needed.
- Candidates should have experience in pharmaceutical/biotech processes, and familiarity with documentation in a highly regulated environment.
About Advantage Resourcing
Advantage Resourcing is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact us. Advantage Resourcing is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.
All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.