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. Applicant Notices & Disclaimers For information on benefits, equal opportunity employment, and location-specific applicant notices, click here At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 85.00/hr.