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Equipment Validation Engineer (cGMP – ISO 13485 – Medical Device) JD820736

JD820736

DPS is looking for a proven Validation Engineer to work with a medical device client in the Providence RI area. This individual will be responsible for the validation of equipment and processes used to produce medical devices. The successful candidate will be primarily responsible for validating existing manufacturing equipment and processes as the client prepares to begin clinical development. Ideal resources should have a depth of experience in cGMP and ISO 13485 environments.

Category:
Engineer Validation & Commissioning
Location:
Rhode Island
Years of Experience Req.:
5+
Date Posted:
15/06/2020
Days Remaining:
29
Employment Type:
Full-time
Education Level Req.:
Bachelors

 

Equipment Validation Engineer (cGMP – ISO 13485 – Medical Device)                     JD820736

 

Providence, RI area

 

 

 

DPS is looking for a proven Validation Engineer to work with a medical device client in the Providence RI area. This individual will be responsible for the validation of equipment and processes used to produce medical devices.  The successful candidate will be primarily responsible for validating existing manufacturing equipment and processes as the client prepares to begin clinical development. Ideal resources should have a depth of experience in cGMP and ISO 13485 environments.

 

 

 

Responsibilities:

 

·         Develop, design and execute validation protocols.

 

·         Review and approve engineering change control, plant validation protocols and reports.

 

·         Establish, coordinate and act as subject matter expert for the site's Master Validation Plan, schedule, execution of schedule, validation police and practice.

 

·         Write, review and approve validation change controls and validation protocols IQ OQ PQ PV standard operating procedures, standard calibration methods, standard test methods, specifications CAPAs and exception reports.

 

·         Draft and implement Quality System documentation designed to establish good validation practices within the Organiz575034.644878ation.

 

·         Design validation approaches, supported by appropriate statistical analyses, draft validation protocols, perform and/or coordinate all validation activities, analyz575034.644878e and assemble results, and draft validation reports.

 

·         Responsible for supporting both equipment and process validations. Experience in validating custom-built (i.e., not off-the-shelf) robotics is highly desirable.

 

·         Provide input on user and/or functional requirements of current and/or future processing equipment, and draft appropriate documentation.

 

·         Interface with Contract Manufacturers to ensure all relevant user and/or functional requirements are met.

 

·         Provide support to non-engineering staff including those from R&D and manufacturing, to ensure successful technology transfer and continuous improvement.

 

 

 

Education and Qualifications:

 

·         Bachelor's degree in engineering, science or technical discipline.

 

·         Minimum of 5+ years of experience working within a medical device environment. Experience with device-biologic combination products is highly desirable.

 

·         Working knowledge of process instrumentation and controls including robotics.

 

·         Must have commissioning and qualification experience, including IQ/OQ/PQ testing.

 

·         Experience drafting and reviewing Master Validation Plans, equipment SOPs, and preventative maintenance procedures is highly desirable, as is an understanding of FAT/SATs.

 

·         Familiariz575034.644878ation with ISO 13485, ISO 14971, and 21 CFR Parts 11 and 820 as well as working knowledge of cGxP theory and practices.

 

·         A strong understanding of statistical analyses is required, as are strong technical writing and presentation skills.

 

·         Must be able to work independently with adequate supervision, multi-task and support several projects simultaneously.

 

·         Must demonstrate strong interpersonal and teamwork skills.

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