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30 days old

Project Engineer

Kelly Services
Tampa, FL 33603
Kelly Engineering is currently looking to hire a Project Engineer to work for one of our top Pharma/Medical Device clients on-site in in the Tampa, FL area for a long-term contract position.



**Key Responsibilities:**



Lead and support aseptic equipment, facility, and process engineering projects related to capacity expansion, manufacturing process improvement, continuity of supply and maintenance of business.



**Key activities/responsibilities include:**




+ Identify new aseptic process technologies and equipment to reduce manufacturing and material costs and improve manufacturing process efficiencies.

+ Lead and support cross-functional project teams responsible for creating engineering project plans and schedules including: development of design requirements/specifications, definition of User Requirements Specification URS, equipment and process testing and validation plans, manufacturing process development and optimization.

+ Support development of business case and justification for potential improvement project opportunities.

+ Lead and support design reviews for new or modified equipment and manufacturing processes to ensure product quality, process performance, and regulatory compliance.

+ Lead trouble-shooting of existing equipment and manufacturing process issues and apply tools such as root cause analysis and Design of Experiments DOE to drive understanding of primary failure modes.

+ Work closely with equipment suppliers, consultants, contractors and participate in supplier evaluation, selection and qualification processes.

+ Lead technology transfer activities for new or modified manufacturing processes to ensure a smooth transition into production.

+ Manage equipment qualifications and validations including the development and approval of all required documentation.

+ Manage and support floor level execution product / process qualifications and validations including material changes, process improvements, and scale up projects.

+ Support the change management process for each assigned project.



**Qualifications:**




+ BS in Mechanical, Chemical Engineering, Materials Science or related engineering discipline.

+ 5+ yrs. project engineering experience with aseptic pharmaceutical and/or medical device projects.

+ Experience in direct support of aseptic process development, manufacturing, and technology transfers.

+ Preferred experience in aseptic solution and suspension filling operations.

+ Demonstrated skills in aseptic manufacturing process design and capital equipment design, selection and qualification.

+ Knowledge of pharmaceutical and/or medical device regulations is required.

+ Familiar with ISO-9000 and cGMP.

+ Demonstrated project management experience with cross-functional and cross-disciplined engineering teams.

+ Strong troubleshooting and analytical capabilities with experience in root cause analysis and Design of Experiments DOE.

+ Strong communication and interactive skills and capable of working independently or on project teams as required.

+ Familiar with project development phases/gates methodology.


**Why Kelly** **** **?**



Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2020-12-16 Expires: 2021-01-18

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Project Engineer

Kelly Services
Tampa, FL 33603

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