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CSV Engineer (cGMP – Medical Device – Robotics) JD820735

JD820735

DPS is looking for a capable Computer Systems Validation Engineer to work with a medical device client in the 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 and collaborate with business partners to maintain and improve computer system validation processes to ensure robust, efficient, and compliant processes.

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

CSV Engineer (cGMP – Medical Device – Robotics)                  JD820735

Providence, RI area

 

DPS is looking for a capable Computer Systems Validation Engineer to work with a medical device client in the 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 and collaborate with business partners to maintain and improve computer system validation processes to ensure robust, efficient, and compliant processes.

 

Responsibilities:

Design validation approaches, supported by appropriate statistical analyses, draft validation protocols, perform and/or coordinate all validation activities, analyz295982.543244e and assemble results, and draft validation reports.

Experience in validating custom-built (i.e., not off-the-shelf) robotics is highly desirable.

May review and approve computeriz295982.543244ed and automated systems validation documentation to ensure documentation is compliant with procedures and all applicable quality system regulations or standards.

Exercises judgment in selecting methods and language to provide compliant solutions to address and document issues, which may arise during validation activities.

Recommends continuous improvement activities to streamline validation processes.

 

Education and Qualifications:

Bachelor's degree in Computer Science, Information Systems/Technology, or Engineering.

Must have 5+ years’ experience within an FDA and/or GxP regulated environment. Proficient in system and software validation engineering processes, risk management, V&V methodologies, configuration management, and knowledge of regulatory compliance pertaining to computeriz295982.543244ed systems validation.

Demonstrated understanding of FDA Quality System Regulation and ISO/EU standards pertaining to computer software validation i.e. 21 CFR Part 820, subpart G Production and Process Controls, 820.70) software validation/automated processes; 21 CFR Part 11 Electronic Records and Signatures; ISO 13485, 7.5.2 Validation of processes for production and service provision, section 7.5.2.1 General requirements).

Proven ability of working in a cross-functional team environment with excellent leadership, interpersonal and communication skills. Proficient in presenting data to management.

Ability to influence others through persuasive, logical, and constructive debate based on data.

Excellent analytical, verbal, writing, prioritiz295982.543244ation, and multitasking skills.

Prefer experience and/or training in software quality engineering principles, GAMP principles or in Information Systems (IS)/Technology related to compliance within a regulated industry.

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