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      Urgent! GxP Validation Engineer/Analyst (Lab Equipment) Position in Cambridge MA - WHITE COLLAR TECHNOLOGIES INC
 
                        
                         Job Description Job Description Responsibilities: · Provide support to the QC Analytical department for activities required to maintain CGMP status of QC Instrumentation hardware and software and to perform comparability studies for the implementation of analytical assays on new instrumentation.
This scope includes QC Instruments (both portable and computer-controlled).
· Authoring Corrective & Preventive Action plans (CAPAs) for systems with long-term remediation activities, and authoring final reports for systems with short-term/completed remediation · Performing supporting remediation work in the form of SOP revisions · Executing change controls and validation test plans/protocols when required per remediation plans · Responsible for the development and execution of general deliverables, such as Risk Assessments, Validation Plans, Change Impact Assessments, Design Specifications, User Requirements, Functional Requirements, Configuration Specification, Requirement Trace Matrices, IQ/OQ/UAT/PQ Protocols, and Summary Reports.
Desired Skills and Experience: · Author, maintain, revise, and/or approve of the Validation Plan.
· Lead the resolution of deviations noted during protocol execution.
· Manage and approve vendor’s documentation as appropriate.
· Ability to impact and influence people/areas in matters related to Validation and GxP compliance.
· Ability to work in a fast-moving dynamic small company environment.
· Ability to mentor junior team members.
· Experiences in other validation areas which may include CSV qualification and Facility Equipment and Utility is a plus.
Required Qualifications: · Validation experience in a biotech/pharmaceutical environment, specializing in Instrument or Computer System Validation · Bachelor's Degree in Engineering, Life Science or Computer Science is required.
· Excellent working knowledge of process automation and computer system validation concepts, GAMP methodologies, CFR Part 11 Electronic Records and Signatures requirements and latest industry expectations for data integrity.
Company Description White Collar Technologies is a boutique human capital consultancy firm specializing in information technology and engineering consulting for life science sector.
Our consultants serve multitude of clients within Pharmaceutical, Biotech, Medical Device, Clinical Research and Healthcare verticals.
We offer our workers Medical Dental and Vision healthcare benefits.
Company Description White Collar Technologies is a boutique human capital consultancy firm specializing in information technology and engineering consulting for life science sector.
Our consultants serve multitude of clients within Pharmaceutical, Biotech, Medical Device, Clinical Research and Healthcare verticals.rnWe offer our workers Medical Dental and Vision healthcare benefits.
                      
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Unlock Your GxP Validation Potential: Insight & Career Growth Guide
Real-time GxP Validation Jobs Trends in Cambridge, MA, United States (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for GxP Validation in Cambridge, MA, United States using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 2556 jobs in United States and 4 jobs in Cambridge, MA. This comprehensive analysis highlights market share and opportunities for professionals in GxP Validation roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! WHITE COLLAR TECHNOLOGIES INC is currently hiring and seeking a GxP Validation Engineer/Analyst (Lab Equipment) to join their team. Feel free to download the job details.
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An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at WHITE COLLAR TECHNOLOGIES INC adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a GxP Validation Engineer/Analyst (Lab Equipment) Jobs United States varies, but the pay scale is rated "Standard" in Cambridge MA. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for GxP Validation Engineer/Analyst (Lab Equipment) typically include Other General and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
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Before the Interview:To prepare for your GxP Validation Engineer/Analyst (Lab Equipment) interview at WHITE COLLAR TECHNOLOGIES INC, research the company, understand the job requirements, and practice common interview questions.
Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the WHITE COLLAR TECHNOLOGIES INC's products or services and be prepared to discuss how you can contribute to their success.
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