Project Engineer, R&D Bioprocessing Custom Hardware

General Electric Framingham , MA 01702

Posted 10 months ago

Role Summary:The Project Engineer, R&D Custom Hardware position, in the GE Healthcare Life Sciences business will focus to execute custom projects and engineering services for single use bioreactor hardware systems (XDR). This position requires the application of design, engineering, product testing and good documentation practices. You will executes technical tasks on multiple projects as assigned, and contribute to engineering efforts in resolving process and/or quality issues.

Essential Responsibilities:
Executes the design, analysis, or evaluation of assigned tasks using sound engineering principles and adhering to business standards, practices, procedures, and product / program requirements.

Creates and maintains detail and assembly drawings, component specifications and associated Bills Of Materials (BOMs).

Generates and maintains project-specific product documentation such as P&ID, general assembly drawing, general system specifications, test protocols and assembly instructions.

Participates in and prepares materials for technical design review meetings.

Releases components and product documentation through ECR/ECO process.

Collaborates with other members of the project team in providing design engineering and project documents for transfer to manufacturing.

Assists with verifying product performance against design inputs and user requirements.

Assists with resolving design, documentation and/or quality issues during system's build and testing phase.

Supports customer case management tasks for custom products in the field as needed.

Ensures that project and product documentation is in conformance with Regulatory, EHS, and GEHC QMS requirements.

Awareness of GMP and governmental regulations related to process equipment used in bioprocessing.

Quality Specific Goals:

Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.

Complete all planned Quality & Compliance training within the defined deadlines.

Identify and report any quality or compliance concerns and take immediate corrective action as required.

Support compliance/closure of Regulatory and Quality requirements before completing Design Outputs/Program Deliverables.

Participate in continuous improvement activities by supporting the implementation of process and product quality improvement initiatives.

Qualifications/Requirements:
Bachelor's Degree in Mechanical engineering, Electrical Engineering, Software Engineering, Computer Science, Industrial Engineering, or related field.

Minimum of 3 years hands-on design and implementation experience in either: bio-processing, process equipment, biotechnology, medical device development or related project engineering field.

Broad exposure to multiple engineering disciplines (Mechanical, Electrical, Software, etc.)

Ability to read and interpret engineering drawings, technical procedures and specifications.

Strong communication and technical writing skills for working with global manufacturing, commercial and customer support team.

Desired Characteristics: Master's degree in Engineering/Science and 3-to-5 years relevant work experience

Self-starter, energizing, results oriented and able to multi-task

Excellent teamwork, coordination and communication skills

Ability to meet aggressive reliability, performance, cost, serviceability, and delivery targets

Quality and Compliance documentation focused

Experience with regulated industries (GMP, GAMP,FDA)

Project management experience

About Us:GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE's mission and deliver for our customers. www.ge.com

Healthcare Life Sciences There is no other life sciences company quite like GE Healthcare Life Sciences. A $5 billion business with more than 11,000 individuals in over 100 countries, we are at work enabling a new era in medicine.

For more than 60 years, GE Healthcare Life Sciences has globally supported the development and use of new therapies, helping accelerate the journey from biological understanding to clinical therapy. GE Healthcare Life Sciences works with cutting edge technology enabling and advancing the discovery, diagnosis and medical treatments of the present and the future. We are accelerating biology to cell therapy in ways no other company can.

Follow us on Facebook and Twitter and watch our discoveries in action on our YouTube channel.

Learn More About GE Healthcare Life Sciences

Learn More About Careers at GE Healthcare Life Sciences

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.


Additional Eligibility

Qualifications:
GE will only employ those who are legally authorized to work in the United States for this opening.Additional Locations:United States;Connecticut, Massachusetts, New Hampshire, Rhode Island;Marlborough, Framingham, Worcester, Boston, Providence, Hartford, Nashua;

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Project Engineer (Cgmp Pharmaceutical) Jd816671

DPS Engineering

Posted 1 week ago

VIEW JOBS 2/9/2020 12:00:00 AM 2020-05-09T00:00 Click here for full job description Senior Project Engineer (cGMP - Pharmaceutical) JD816671 Boston, MA area Summary: DPS is looking for a proven Senior Project Engineer to work with a BioPharma client in the Boston, MA area. Ideal candidates should have a strong understanding of GMPs and experience providing Project Engineering support in highly regulated or pharmaceutical/biotech facilities. This individual should also have a strong understanding around process engineering as well. Responsibilities: * Provide engineering and technical support related to operation, maintenance, design, installation, start-up/commissioning, testing and qualification of product and infrastructure equipment and systems. * Systems may include production equipment such as bioreactors, fermenters, centrifuges, UFDF, Chromatography, CIP skids, and other support equipment such WFI, CS, Process Gases, HVAC, and Core Building Utility Systems. * Support the design and qualification of improvements, changes or upgrades to the equipment and startup and validation documents. * Lead projects of various complexities to support departmental initiatives and participate in various cross-functional teams to support process improvements. * Identify and schedule project events around manufacturing operations. * Identify materials required to support project execution work. * Communicate project requirements to vendors to obtain proposals for equipment and piping changes. * Provide project design and cost estimates. * Manage project implementation including oversight of selected vendors. * Redline drawings to prepare the As-Built set and maintain the site master drawing. * Report project status and progress to Senior Project management. Education and Experience: * Bachelor's degree in Mechanical or Chemical Engineering. * Minimum 5+ years' experience providing Project Engineering support. * Candidate must be able to work across functional areas such as operations, maintenance, quality and validation. * Proficiency in the arena of process, utility and building engineering in cGMP environment within a biopharma facility. * Working knowledge of documents such as P&IDs, URS, FRS, and qualification documents. * Effective verbal and written communication skills. * Excellent interpersonal, teamwork, and leadership skills required. * Participates in determining objectives of assignment and plans, schedules and arranges own activities in accomplishing milestone achievements. In This Section * Submit your Resume / CV * Career Profiles * Job Search * Jobs by Location * Interview Hints & Tips * Graduate and Internships 2020 DPS Engineering Framingham MA

Project Engineer, R&D Bioprocessing Custom Hardware

General Electric