|
|
|
|
 |
If this is a scam, MLM, or Home Based "Opportunity" then Mark as SPAM
|
 |
Thank you for helping! This job will be reviewed by us shortly. Undo
|
| Employer Name: ND Global Consulting Services Inc |
SpiderID: 13938944 |
| Location: Pennington, New Jersey |
Date Posted: 2/4/2025 |
| Wage: 86029 |
Category: Biotech |
| Job Code: |
|
| Number Of Openings: 1 |
|
Job Description:
CQV Engineer needed to perform the following duties:
● Participate in planning, development, and implementation of manufacturing and lab equipment validation and qualification documentation.
● Review/approve and execute the validation protocols (includes IQ, OQ, & PQ) for facilities, laboratory and support equipment, shipping, utility systems and process equipment including cleaning validation.
● Authors and interprets validation reports that reflect the validations performed with and without contractor support by generating the summary reports with detailed standardization of the operating ranges, which supports the manufacturing department of the organization.
● Follow the GMP and GDP practices during the execution of the protocols and preparing the Qualification documents.
● Represent validation during the creation of Validation Strategy Documents and other project related documentation.
● Analyze and understand the GD & T for the generation of 2D drawings and converting the 3D drawings into 2D using Pro-E CREO.
● Prepare the URS as required.
● Review Validation deliverables to assure compliance with 21 CFR Parts 11 (Electronic Signatures & Records), 210, 211, 50, 56, 58 and FDA Regulations in the Software Development Life Cycle (SDLC).
● Validate the Electronic Records and Electronic Signatures in accordance with the FDA Guidelines.
● Create workflow, summary reports using eDoc or Doc compliance and route them for QA approval, ensure that all the documentation related to quality validation is in compliance with FDA and CGMP regulations and provide technical support to the validation group as needed.
● Initiate and participate as appropriate in associated change control requests, deviations, CAPAs and equipment acquisition documentation
● Works under consultative direction to perform corrective actions to address validation discrepancies and identified measurement problem. Using Root Cause Analysis investigates the problem and finds the resolution for problems.
● Work checked through consultation and agreement with others rather than by formal review of superior.
● Perform continuous improvements by developing best and proven practices in the department based upon current industry, US and EU guidelines.
● Design and execute protocols for IQ and OQ of Buffer Preparation and pH adjust, Media Preparation Vessels, Waste systems, Docking Stations, Transfer Lines, and to validate equipment, fully automated CIP skids for cleaning of all types of equipment, Filtration skids, Fermentation Vessels, facilities and utilities. thermal validation, such as-20°C and -80°C freezers, water jacketed CO2 incubators, and 2-8°C refrigerators. Execute Clean-in-place (CIP)/ Sterilization-in-place (SIP) cycle development; spray coverage-testing, sample/swab testing for different manufacturing equipment’s.
● Control temperature storage (incubators, refrigerators, cold rooms, freezers, and stability chambers), air handler system (AHU) and clean room, utilities (nitrogen, compressed air systems, and WFI distribution system), isolator, weight scale, oxygen sensor, temperature transmitter, down flow booth, vessels, filling, and tray dryer.
● Develop sampling strategies and effective techniques to collect samples to improve existing protocol and collected the sampling locations for swabbing from protocols work on aseptic sampling, aseptic clean hold time studies, Bioburden sample collection, TOC and Endotoxin sample collection, Rinse and negative control sample collection and SWAB sampling.
● Manufacturing equipment are supported by DeltaV software with configurable code. Performed code configuration related installation and functional testing.
● Develop the Piping and Instrument Diagrams (P&ID) for the existing equipment.
● Understand the process flow within the industry for the development of the product and prepare the Process Flow Diagram (PFD) for organization.
● Prepare the list for the preventive maintenance and schedule for the maintenance of all the equipment’s within the manufacturing, quality, and R&D departments.
● Provide input into the development and maintenance of Validation related Master Plans, SOPs, work instructions, and forms.
● Validating the computer systems and supporting the IT team.
● Coordinate the IT, Validation, and Quality Assurance departments for the development of Computer Systems Validation protocols.
● Setting up the software in the equipment and assigning the access levels to operators, supervisors, and admin level access to particular sector.
● Building Use-Case Diagrams, Sequence Diagrams, High Level Documents, System Architecture Diagrams, System Integration Strategies, Business Solutions Proposal.
● Analyze and understand the GD & T for the generation of 2D drawings and converting the 3D drawings into 2D.
● Supporting Multiple Phases of testing Drafting and executing different testing phase protocols like Installation Qualification, Operation Qualification and Performance Qualification.
● Manages, Inspects and Calibrates the instrumentation.
● Supervise Equipment Vendors and Execute Site Acceptance Testing.
● Creation/modification of change control requests, project plans and maintaining project timelines.
● Drafting of change control request and monitoring changes throughout the project for new and existing equipment or procedures in accordance with company and FDA regulations.
● Review/approve the System Development Life Cycle (SDLC) documents pertaining to the laboratory, facilities, manufacturing and infrastructure of computerized systems used for cGMP purposes.
Job Requirements:
Bachelor’s degree is required in Mechanical Engineering or Engineering Management.
Job Criteria:
Start Date: 02/10/2025
Position Type: Full-Time Permanent
Years of Experience Required: 3
Education Required: Bachelors
Overnight Travel:
Vacation Time:
Job Benefits:
Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave
Contact Information:
| Contact Name: Rashmi Kumari |
Company Type: Staffing Agency |
| Company: ND Global Consulting Services Inc |
|
|
|
| City: Tampa |
|
| State: Florida |
|
| Zip: 33647 |
|
Web Site: https://www.ndgcs.com
|
|
|
|
|
|