Project Manager – Downstream Biologics
Validation & Engineering Group, Inc. · Cincinnati, OH · 1 mo ago
On-siteInformation TechnologyFull-time
Responsibilities
- Lead capital projects within downstream biologics manufacturing, supporting capacity expansion and facility enhancements within existing operations.
- Manage projects through the full project lifecycle from concept through engineering, construction, and CQV, ensuring alignment with business and site objectives.
- Drive capacity expansion initiatives within existing manufacturing facilities.
- Cook up cross-functional teams including Engineering, Site Operations, and CQV stakeholders.
- Present project updates, project status, and key decisions to Global Engineering leadership and site executives.
- Ensure adherence to scope, schedule, cost, and quality objectives.
- Manage project execution to support business goals and site operational requirements.
- Facilitate communication and collaboration across project teams and stakeholders.
- Support project planning, risk management, and decision-making throughout the project lifecycle.
Qualifications
- Experience leading capital projects within pharmaceutical, biotechnology, or biologics manufacturing environments.
- Strong knowledge of downstream biologics manufacturing processes, including fill/finish, cell culture, reactors, and associated process systems.
- Experience managing projects through engineering, construction, commissioning, qualification, and validation (CQV) phases.
- Experience supporting manufacturing capacity expansion projects within existing operating facilities.
- Strong project management skills with demonstrated ability to manage scope, schedule, cost, and quality objectives.
- Experience leading cross-functional teams and coordinating multiple stakeholders.
- Strong leadership, communication, and presentation skills.
- Ability to present project updates and strategic recommendations to senior leadership and executive stakeholders.
- Strong organizational, analytical, and problem-solving skills.
- Able to manage multiple priorities in a fast-paced project environment.
- Available to work extended hours, possibility of weekends and holidays.