New 
Commissioning and Qualification Manager
 Spectraforce Technologies | |
 United States, Ohio, Cincinnati | |
 Feb 17, 2026 | |
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P
osition Title:
Commissioning and Qualification Manager
Work Location: OH-Cincinnati Assignment Duration: 06 months Purpose: Overall management of the commissioning and qualification phase of FUE (facility, utility, and equipment) of a new packaging line program at the site in Cincinnati, Ohio. Work with site core functional teams on integrated schedules, resourcing management, and C&Q execution. Manage (and onboard where required) C&Q subject matter experts and the entire C&Q lifecycle in an efficient manner. Responsibilities: * Planning and coordination of C&Q activities in line SOPs. * Deliver program updates to both senior management and senior leadership as required. * Onboard and Manage a C&Q team to deliver this key program for. * Articulate and incorporate all C&Q deliverables into project scheduling tools and delivery outputs. * Responsibility for meeting customer requirements and the necessary regulatory requirements as defined by FDA, EU and regional Ministries of Health as relevant. * Drive risk assessments ensuring a well-defined risk-based approach is developed and maintained throughout the project lifecycle. * Participate in team meetings and workshops as required. * Generate, Execute, review and approve documentation as necessary ensuring project documentation is of the highest standard. Qualifications: * Degree in an Engineering, Science or Computer Science discipline * 10 Years' experience in a pharmaceutical / Medical device background. * Knowledge of Pharmaceutical Regulatory Requirements and expectations * Knowledge of a wide range of C&Q disciplines including Utility, Facility & Equipment qualification. * Self-directed, self-motivated with an ability to represent the C&Q function in a high paced project environment * Ability to work closely with key project stakeholders to maintain project delivery schedules and limit any potential delays. * Must have previous experience in a project management role. Management of contract staff in a previous role is beneficial. | |