Multi-national Pharmaceutical company seeks a Process Validation Engineer who can develop IQ-OQ-PQ protocols for our new production cells.

Shall:

*** Be responsible defining, implementing, and maintaining a robust process validation program.

*** Work with biological handling and cold chain processes, aseptic processing, cleaning, and sterilization processes.

*** Develop Policy & Procedures and Manage Validation Programs. Act as Process Validation subject matter expert for resolution of deviations, assessment of change orders and other quality system actions.
 
*** Oversee and execute selected studies and protocols for processes and systems. Perform periodic process review and re-validation to ensure continued compliance.

Required Qualifications:

*** BS degree in a scientific discipline with at least 5 years of direct validation experience.

*** In depth, working knowledge of FDA Aseptic Process Guidance for Industry.

*** Experience implementing Process Validation Program, Quality Risk Management concepts.

Excellent opportunity to join a world recognized organization with multiple tiers of career advancement. Be a part of an organization with a history of over 80% employee retention and some of the most technologically advanced scientific facilities in the country. With comprehensive benefit packages, generous time off, excellent vacation and time off, and starting salary to $120,000 this opportunity must not be missed.

For complete details contact Alex Riddle at:
(609) 584-9000 ext 210

Or submit resume online at:
http://dmc9.com/war/app.asp

Or email to:
1000011451_10007298@candabcseek.com

Please reference #34216 when responding.
 
Education Requirements: Bachelor Degree
Minimum Experience Requirements: 5-10 years
Job City Location: Westborough
Job State Location: MA
Job Country Location: USA
Salary Range: $90,000 to $120,000

WE ARE AN EQUAL OPPORTUNITY EMPLOYER and our employment decisions are made without regard to race, color, religion, age, sex, national origin, handicap, disability or marital status. We reasonably accommodate individuals with handicaps, disabilities and bona fide religious beliefs. Jobs Career Position Hiring. CONSIDERED EXPERIENCE INCLUDES: Http://najobbank.com Www.najobbank.com Top 10 Job Site Top 10 Career Site Quality Assurance Engineer Sterile Pharmaceutical Packaging Quality Engineer Medical Device Manufacturing & Sterile Packaging Pharmaceuticals Sterile Manufacturing & Packaging Quality Engineer 21 CFR 210 211 21 CFR Part 820 cGMP Aseptic Filling & Packaging Current Good Manufacturing Practice Combination Products Biologic Products Drug Products Diagnostic Reagents Quality Engineering IQ-OQ-PQ IQ OQ PQ Installation Qualification Operational Qualification Performance Qualification FDA Aseptic Process Guidance FDA cGMP Clinical Good Manufacturing Practice ANSI-ISO-ASQC CMDA American National Standard American Society For Quality

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