Key skills
CommunicationTime Management
About this role
Role Overview
- Work with key stakeholders and vendors to evaluate new technologies for implantation into the manufacturing process to increase efficiency and facility throughput.
- Develop design documents (user requirement specifications, software functional specifications) based on platform process requirements and validation commissioning and qualification protocols
- Collaborate with the automation team on design and development of the Distribute Control System (DCS) with the manufacturing suite.
- Support technical evaluations of the facility utility requirements.
- Lead evaluation of single-use technologies and design single-use manifolds and assemblies.
- Work with vendors to develop data and validation packages supporting technologies.
- Facilitate procurement and implementation of approved new technologies.
- Develop business processes, guidelines, SOPs, and training for processing equipment and technologies.
- Lead the development equipment maintenance & life cycle plans.
- Lead non-conformance/deviation investigations and provide process impact evaluations of equipment/technology issues.
- Lead technical exchanges problems and solutions throughout the manufacturing network.
- Participate in internal and external audits/inspections.
Requirements
- BS in engineering, sciences, or related life science engineering
- 5+ years of relevant experience in Pharmaceutical, Biotech, or Life Sciences industries, or MS with 2+ years of experience
- Considered a subject matter expert in biopharmaceutical manufacturing single-use processing equipment and technologies
- Experienced in leading technology implementation and validation activities for clinical and commercial manufacturing readiness
- Working knowledge of cGMP manufacturing and regulatory regulations and requirements for biologics/pharmaceuticals
- Solid understanding of monoclonal antibody processing either at manufacturing scale or in process development
- Experience working with single-use disposable manufacturing systems
- Demonstrated ability to work independently and collaboratively on cross-functional teams
- Working knowledge of manufacturing process equipment and automation systems
- Candidate must focus on quality, attention to detail, and effective task/time management and organizational skills
- Ability to organize, analyze/interpret, and effectively communicate process data
- Excellent oral and written communication skills.
Benefits
- discretionary annual bonus
- Medical, Dental and Vision
- short-term and long-term disability
- company paid basic life insurance
- 401k company match
- flexible work
- generous paid time off
- paid holiday
- wellness and transportation benefits