Sr. Validation Engineer - TX..

Sr. Validation Engineer

REQ. SKILLS:    Sr. Validation Engineer - 21 CFR 820

START DATE:  3/9/2014

LOCATION:    Ft. Worth, Texas

INTERVIEW:   phone screen and Skype     

DURATION:  12 months

 

 

Duties:

The Validation Engineer will ensure proper validation of equipment and measurement/inspection systems used for both production and Design Testing.

This position will be an integral part of R&D in support of Design Verification and Design Transfer activities.

The ideal candidate will have a firm understanding and practical experience with Medical Device Quality System Regulation requirements (21 CFR 820), cGMP/GxP requirements and key industry validation principles/guidance documents (GHTF).

The Validation Engineer will actively participate in the design and development of overall validation strategies, write individual test plans/protocols using appropriate statistical techniques and following a risked-based approach to validation, manage validation execution including deviations, review/analyze validation results and write validation reports.

 

Skills:             

 

Adept at partnering with various Subject Matter Experts (project team members, scientists, engineers, QA, etc.) in order to create and execute validation strategies consistent with operational and compliance needs

Must be able to write and execute  measurement/inspection systems equipment

Validations including Computerized Software Validations (CSV)

Able to use and apply Six Sigma methodologies and tools such as; GRR, Process Capability, DOE

Must be able to use statistical analysis software such as; Minitab, JMP, etc.

Excellent verbal and written communications

Strong decision making and problem solving skills

 

PRINCIPAL RESPONSIBILITIES:

 

Ensure timely execution of equipment validation activities in support of project objectives and in compliance with local SOPs.

Develop and implement verification and validation documentation (i.e. Master Validation Plans, IQ/OQ/PQ/CSV/TMV protocols and summary reports) in collaboration with Instrumentation Engineers,  Users and Quality Ensure responsible departments execute activities according to applicable SOPs and Validation Master Plan(s) Partner with Quality and other area/site validation leads to establish and maintain common validation approach for the sites.

Partner with Quality and other functional areas to define process validation strategies Develop statistical sampling plans; Perform statistical analysis of test data (i.e. Hypothesis Testing, Normality Testing) Perform or oversee risk assessments for Validations

 

QUALIFICATIONS:

This position will require a minimum of a Bachelor's Degree in Engineering or a scientific discipline with a minimum of 5 years work experience in the Medical Device Industry and a minimum of 2 years validation experience with Medical Devices. Preferred experience in computer systems validations and Measurement System Analysis (MSA). Design Control experience and Certification as a Six Sigma Green Belt or Black Belt a plus. Part 11 compliance knowledge is a plus.

 

KEY WORDS:

 

Test Method Validation

Measurement System Analysis (MSA/GRR)

Process Validation

Computerized System validation (CSV)

QSR 21 CFR 820

GHTF

IQ, OQ, PQ

 

 

Regards,

Manju Shree

Sr IT Recruiter
IDC Technologies, Inc. 1851 McCarthy Boulevard, Suite 116,Milpitas, CA, USA, 95035
Phone: 408-418-5779 ext 1012 |Fax: 408-608-6088 |

Email: manju@idctechnologies.com| Web: www.idctechnologies.com

 

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