The Senior Process Engineer is responsible for supporting the implementation of new product and new process introductions into manufacturing, and ensuring that all activities are completed and documented in accordance with the Quality System requirements. Serve as the voice of operations between the development site and manufacturing site during the new product/process development phase. Defines and develops systems to monitor assigned operations post-implementation to assure compliance with approved methods and quality standards. Knows and applies fundamental and advanced concepts, practices and procedures within the manufacturing engineering specialization.
The Senior Process Engineer will be responsible for designs, developing, testing, and evaluating manufacturing systems (assembly and packaging operations) during conceptual and pilot development and the introduction of new programs into production.
List of Responsibilities:
* Plans, schedules, conducts, and coordinates assigned engineering work; monitors work for compliance to applicable codes, standards (i.e. FDA, ISO, OSHA) and accepted engineering practices.
* Coordinates the launch of new product designs and enhancements to existing product designs to ensure smooth transition to full production.
* Interfaces with the Development, Quality, Manufacturing, Supply Chain functions as well as suppliers to conduct problem solving activities.
* Assures smooth implementation of new and revised product and process designs into production.
* Performs design reviews and pre-validation assessments to ensure a smooth startup of new processes.
* Performs analytical problem solving and utilizes structured decision making skills.
* Confers with management, and other staff regarding manufacturing capabilities, production schedules, and other considerations to ensure smooth transition of new or enhanced product and/or processes to full production.
* Participates in or lead problem solving team projects.
* Conducts moderately complex projects where analysis of situation requires a thorough and robust knowledge of various identifiable engineering methods and factors.
* Provides guidance to engineering technicians on assigned tasks and projects.
* Guides the successful completion of projects and may function in a project leadership role.
* Develops operating procedures and/or work instructions to ensure adequate manufacturing practices per FDA requirements.
* Maintains safe and clean working environment by enforcing procedures, rules and regulations.
Skills & QualificationsMUST:
Must have solid knowledge on Process and Equipment Validation and leading projects
Have 7+ years' relevant experience of Process and Validation in an FDA regulated environment (IQ/OQ/PQ)
BS in Engineering (preferably Mechanical or Biomedical).
Must be able to communicate appropriately and accurately both orally and in writing the progress of assignments and product development efforts.
Must be able to complete effective Validations with a moderate to complex scope.
Must have practical experience and solid understanding of mechanical design principles, testing and manufacturing processes.
Experience in project management and leading small teams.
Ability to handle multiple tasks concurrently.
Independent thinker and problem solver.
-Experience with Packaging and/or assembly would be a plus
-Experience with Vision Systems or CVS or Labeling Systems
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.