Note: The job is a remote job and is open to candidates in USA. Validation & Engineering Group, Inc. is a leading services supplier providing solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries. They are seeking a Project Manager for Downstream Biologics to lead capital projects within downstream biologics manufacturing, ensuring alignment with business and site objectives.
Responsibilities
- Lead capital projects from initiation through design, construction, and CQV completion
- Manage projects related to downstream biologics processes, including fill/finish, cell culture, reactors, and related systems
- Drive capacity expansion initiatives within existing manufacturing facilities
- Coordinate 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
Skills
- 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
- Ability to manage multiple priorities in a fast-paced project environment
- Available to work extended hours, possibility of weekends and holidays
Company Overview