Editor in Sound Design supporting audio development across Paramount's projects. Creating impactful sound and collaborating with diverse teams on various media formats.
About the role
- Director of Sterile Engineering leading operations at FLEx Center and Sterile Liquids Pilot Plant. Ensuring compliance and innovation in sterile drug product manufacturing.
Responsibilities
- Oversee facility start-up /readiness for FLEx2 (GES capital project) and the daily operation of FLEx1 (facility in operation).
- This includes equipment engineering, automation, bio-sterile validation, maintenance & calibration, safety and compliance requirements to support development or GMP activities
- Oversee engineering activity and support for the Sterile Liquids Pilot Plant (WP17 SLP)
- Manage, develop, and grow a team of facility-facing engineers
- Provide trouble-shooting support on the shop floor
- Support internal capability development by evaluating and deploying innovative sterile manufacturing technologies to support new product development, both automated and non-automated
- Collaborate effectively within and across functional areas and possess advanced knowledge or experience in specialized engineering areas.
- Develop and lead Commissioning, Qualification & Validation activities (CQV)
- Participate in external and internal audits, tours, and inspections
- Ensure closure of investigations, as needed
- Establish and manage expense and capital projects, including expenditures via financial budgets and forecasts associated with the FLEx Center and the SLP
- Maintain facility and equipment systems in a state of permanent inspection readiness
- Recruit and develop staff, through objective setting, rewards and recognition, stretch leadership and/or technical assignments, and learning opportunities that broaden experience
- Sponsor and drive a culture of continuous improvement across these facilities
Requirements
- Bachelor's degree in Engineering, Pharmaceutical Sciences or related scientific field with a minimum of 10 years of relevant experience.
- Knowledge of and experience supporting sterile Drug Product manufacturing, including the use of advanced product filling and formulation equipment, application of isolators and advanced robotics
- Sterile engineering experience in a GMP clinical or commercial manufacturing environment
- Effective interpersonal and communication skills, both verbal and written
- Excellent organizational skills to manage multiple priorities
- History of independent problem-solving
- Experience with leading complex teams / matrix management
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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