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Net2Source (N2S) • Warren Township, New Jersey, United States
Salary: 26% compa
Role & seniority: Commissioning/Qualification Specialist (mid-to-senior level) responsible for client project commissioning and qualification efforts.
Stack/tools: Knowledge of cGMP; validation strategy development; documentation management (drawings, manuals, test certificates); coordination with Client Engineering/Quality, project team, and subcontractors; familiarity with Client corporate standards.
Obtain, assemble, and distribute commissioning/qualification documentation for equipment and facilities.
Schedule/coordinator commissioning and validation activities; supervise punch lists and minor modifications.
Develop a detailed plan for collecting/consolidating CQ documentation and provide input to the Project Manager for monthly CQA progress.
Strong knowledge of cGMP and validation planning/execution.
Documentation management and distribution under tight timelines.
Stakeholder coordination (engineering, QA, project teams, subcontractors).
Ability to align activities with corporate commissioning standards and requirements.
Experience in pharma/biotech facility commissioning.
SME capability in validation strategy; experience with A/E firms or project teams.
Experience handling regulatory/compliance aspects of commissioning.
Location & work type: Location not specified; work type likely contract/temporary staffing engagement with onsite/client-site involvement
Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap Right Talent Right Time Right Place Right Price and acting as a Career Coach to our consultants.
Job Description: Work with Clients Engineering and Quality representatives to obtain, assemble and distribute the necessary documentation (drawings, manuals, test certificates, etc.) required to support equipment and facility commissioning and qualification efforts in the most expeditious manner. Responsible for scheduling and coordinating the commissioning and validation effort on behalf of Client. Complete necessary documentation as requested by the client during the Commissioning effort. Assist in providing supervision to complete punch list items and make minor modifications (as required) to support the commissioning and qualification effort. the Commissioning/Qualification Specialist will familiarize him/herself with Client Commissioning Corporate Standards and Requirements and will be expected to work closely with the project team to include all necessary commissioning activities in the individual sub contractor scope of work packages. Provide a detailed plan for collecting, consolidating and distributing Commissioning and Qualification documentation to Client. Provide the necessary input to the Project Manager for the Project Monthly Progress report on CQA matters Knowledge of the cGMP regulations and application of them in the validation strategy of the projects. Also, it shall act as subject matter expert (SME) representing Client in the validation plan strategy with the stakeholders, Client corporate engineers and A/E firms.
Why work with us - At Net2Source, we believe everyone has an opportunity to lead. We see the importance of your perspective and your ability to create value. We want you to fit inwith an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to stand outwith opportunities to have a strategic impact, innovate, and take necessary steps to make your mark. We help clients with new skilling, talent strategy, leadership development, employee experience, transformational change management and beyond.
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