Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have an exciting contract opportunity with one of our leading clients!

 

Title: Lead Project Engineer

Location: Westborough, MA

Duration: 12 months + (possible contract to hire)

 

 

Lead Project Engineer

Overview


Provide critical bioprocess knowledge to our Product Care Life Cycle Engineering team within the Biotechnology business area.
Provide technical guidance and expertise in the bioprocess area with applications and engineering knowledge of single-use bioreactor systems; cell bags and hollow fiber filtration.
Requires the application of design, investigation root cause analysis, product testing, data analysis and report writing to resolve customer complaints / product issues and implement existing product design improvements, all while working in a cross-functional team environment.


 

Responsibilities


Function as an internal and external technical expert for upstream single-use bioprocessing equipment, products, processing and application methods.
Interface directly with customers, suppliers and internal groups to resolve customer complaint investigations, drive root cause analysis and to implement design, process and supplier quality related solutions.
Lead the design, testing and release of single-use consumable products; components, assemblies, packaging, tooling and fixtures.
Proficient in CAD solid modeling tools; preferably SolidWorks and/or CREO.
Leading product design to meet their intended use. Ensure performance of engineering analyses (support and review FEA, CFD analyses) to lead design decisions.
Create and maintain DHF; detail drawings, specifications, assembly drawings and associated Bill-of-Materials, manufacturing documents, including initial assembly instructions, inspection criteria and packaging instructions.
Verify product performance against design inputs. Write verification protocols, perform testing, analyze and interpret test data, and write and present verification reports.
Create manufacturing documents, including initial assembly instructions, inspection specifications, component specifications, and packaging instructions.
Release products through the ECR/ECO process.
Lead CAPA activities and track Customer Complaint Investigation records in Trackwise System.
Coordinate project priorities with team and Product Managers.
Self-manage tasks. Identify design requirements, perform risk assessments, identify required resources, estimate time and budget, and interface with peers, managers, suppliers and customers.
Maintain a safe work area.


 

Required Qualifications


Bachelor’s degree in either; Mechanical Engineering, Chemical Engineering, Plastics Engineering or Bioengineering.
2 years relevant experience in biopharmaceutical processing, medical device or related Biotechnology field of work.
Bioprocessing experience is a MUST.
Strong experience in plastic part design and GD&T per ASME Y14.5 standards.
Working knowledge of plastic material characteristics, particularly as used in disposable medical devices, or life science or biomedical products.
Knowledge of bio-compatible material selection for sterile single-use application in bio-processing and/or medical device applications.
Strong understanding of materials, properties, Mfg. processes, and product assembly.
Awareness of GMP and governmental regulations related to drug manufacturing sufficient to appreciate the need for documentation accuracy.
Ability to read and interpret professional journals and technical procedures, write test protocols and reports; communicate test analysis and results.
Proficient with Microsoft tools; Word, Excel, Power Point, Project and Visio.
Hands-on experience designing, prototyping and testing of components and assemblies.
Excellent communication and influencing skills and ability to gain buy-in for initiatives.


 

Preferred Qualifications


Master’s degree in either; Mechanical Engineering, Chemical Engineering, Plastics Engineering or Bioengineering.
Proficient with MS Project to create Project Plans, Work Breakdown Structures (WBS) and Gantt chart schedules.
Experience in CAE analysis tools; FEA, CFD and MoldFlow.
Outstanding communication and writing skills for working with global manufacturing, marketing, and development teams.
Experience in leading projects/activities to meet customer requirements.
Familiarity with relevant regulatory and Q/A guidelines governing single-use plastic components such as Biocompatibility requirements per USP Class VI and ISO-10993.
Six Sigma Certification (Green Belt, Black Belt) or knowledge of DFSS.
Experience working in an Agile work environment.
Application of Risk Management methodologies to aid in meeting commitments


 

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Please contact Taryn Carbone (taryn.carbone@kellyservices.com) for immediate consideration.
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/nontraditional 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]]