Validation SpecialistApply Now
- United States
Job Title: Sr. CSV/Quality Consultant for Lab Systems
Location: Whitehouse Station, NJ
Type of Assignment: Contract/Full Time
- Act as Validation and Qualification Lead on a large global laboratory remediation projects, with specific focus on Laboratory Standalone COTS systems
- Author the typical validation, qualification, and testing documentation such as Validation Plans/Summaries, Test Plans/Summaries, User Requirements, Configuration Specifications, Trace Matrix, Qualification Protocols (IQ/OQ/PQ) and Scripts, Testing Defects, etc.
- Assist systems users with defining and documenting system use in user, admin, and maintenance SOPs
- Coordinate alignment of systems users from various company sites, including international sites, on validation and qualification documentation
- Proactively communicate with various company organizations and systems vendors to ensure the project hurdles are overcome quickly and effectively
- Provide tactical guidance and coaching in support of systems testing efforts
- Act as validation task lead: take ownership of related tasks, work under minimal supervision, utilize the industry experience and best judgment to make tactical decisions, stay proactive, etc.
- 7+ years of Lab Systems CSV experienced is required. 10+ years are desired
- Specific hands-on experience with validating, qualifying, and/or using Pharmaceutical QC Lab Standalone COTS systems are required
- Understanding of Data Integrity concepts is required
- Experience working with systems users from different sites is required.
- Experience with international sites is highly desired.
- Excellent communication and written skills required
- Excellent communication and writing skills
PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.
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