*Please send resumes to [email protected] <[email protected]>*


Hi,



I have the below requirement with my preferred vendor. Please do let me
know if you have any suitable candidates for the same.

*Role: Process Validation Engineer -Mechanical*

*Duration:* 6-12 Months

*Work location:* Irwindale, CA

*Bill Rate:* $40/hr C2C

*Mandatory Domain:* Mechanical Engineering & Medical Devices industry

*Mandatory Skills:*

§     Need to have Strong *Process validation experience* in medical
devices industry.

§     Strong *medical devices industry* experience.

§     Need to have *Mechanical engineering background*.



*Required skills:*

§     3+ years of medical device process development experience in
production environment.

§     Degree in Mechanical Engineering - B.E / B.Tech / B.S / M.E / M.Tech
/ M.S

§     Knowledge of medical device design controls.

§     Performs and directs process validations, IQ, OQ, PQ, TMVs as
required.

§     Oversees the validation program:  schedules, files, and records.

§     Administers validation training for the facility

§     Demonstrated knowledge of risk management techniques.

§     Interfaces with Quality and Manufacturing Engineers to review
processes, determine validation requirements, and coordinate the validation.

§     Demonstrated knowledge of CAPA process and root cause investigation.

§     Coordinates and performs testing relating to the validation.

§     Familiar with working within formal design control processes, writing
test protocols and reports.

§     Works with suppliers, management, Engineers, and Manufacturing
Associates in the resolution of quality problems associated with the
validation program.

§     Performs internal and external audits associated with validation
activities.

§     Utilizes advanced statistical tools to determine sampling plans and
to analyze data associated with validation activities.

§     Oversees and directs the activities of the Validation Engineers /
Technicians

§     Proven record of interpersonal skills to handle client, Result
oriented and self-driven


-- 
Thanks & Regards,


*Alex Rodriguez*

*Account Manager - Data Group, Inc*

*Ph: 732-734-5343*
*Email: *[email protected]
*Gtalk: *[email protected]
*Website: *http://www.datagroupinc.net
*LinkedIn: *http://www.linkedin.com/in/alexdgrp

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