Title: Commissioning and Qualification ManagerPurpose:Overall management of the commissioning and qualification phase of FUE (facility, utility, and equipment) of a new packaging line program at the AbbVie 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 AbbVie 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 AbbVie. 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 discipline10 Years experience in a pharmaceutical / Medical device background.Knowledge of Pharmaceutical Regulatory Requirements and expectationsKnowledge 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. Enable Skills-Based Hiring No Provide the days of the week and the hours that this position will require: (No Value) 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: $ 7.25/hr.