Senior Process Engineer
Bluebird Bio, Durham, North Carolina, United States
integrated product platforms with broad therapeutic potential
Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene and cell therapy approach in our new vector manufacturing facility in North Carolina’s Research Triangle. As a Senior Process Engineer, you will have responsibilities for critical aspects of the new facility startup and equipment support. The focus of this position is to provide expert support and coordination of equipment selection from initial design through close out. The position is responsible for engineering aspects concerning project execution (schedule, budget, scope, etc.) insuring the completion of quality projects that meet cost, schedule, operational requirements and business needs.
About The Role
- Oversight and execution of capital and/or operating expense projects from inception to completion insuring safety, regulatory and quality compliance. This includes scope development, design, construction and commissioning of equipment, systems and facilities. Organize and lead project teams, assuring that projects are coordinated with team members and compliant with applicable policies/procedures.
- Be flexible and organized to maintain control of projects with shifting priorities. Remain open to different ideas and confirm approach/priorities with management.
- Develop, monitor, forecast, and report project cost and schedule to leadership.
- Manage third party firms for equipment detailed design and commissioning and qualification (C&Q).
- Execute engineering change management, quality events (e.g. change control, corrective action/preventative action, etc.), and project close-out documentation.
- In collaboration with Quality Assurance, develop site strategy for equipment requalification and implementation of program.
- Provide engineering technical support to site operations and validation activities (FAT, SAT, IQ/OQ/PQ, PPQ) with creative approaches, as well as adaptation to corporate, site and/or industry standards/methodology. Diagnose technical issues and current practices and provides recommendation/solution for their correction.
- Responsible owner for development and maintenance of equipment drawings (P&IDs, PFDs, etc) and equipment lifecycle (URSs).
- Provide support to Facilities/Maintenance team for development of a spare parts program and identify spare parts for incoming equipment.
- Ensure potential safety hazards are identified/shared and effective actions are rapidly implemented.
- Embed the highest standards of compliance with our quality systems into the site’s day-to-day activities.
- Must have proficient computer skills and be experienced using MS office software (Word, Excel and PowerPoint) and MS project.
- Must be willing to have a flexible schedule to support 24x7 manufacturing activities. Travel is expected to be approximately 10%.
- BS/MS in Engineering or a related field with 10+ years of experience in a technical engineering role or related areas (or a combination of education and experience) including direct experience in equipment design, procurement, FAT, SAT, and IQ/OQ.
- Minimum 5 years of experience in pharmaceutical/biotech manufacturing, design, or consulting environment, supporting upstream and downstream single use bioprocessing systems.
- Familiar with FDA and EU regulations and GMP standards. First-hand experience with agency filings and inspections is a plus.
- Prior cGMP cell or gene therapy manufacturing experience is highly desired.
- Ability to work in a matrixed-team environment, meet deadlines, and self-prioritize and balance work from multiple individuals and multiple projects.
- High proficiency for problem solving in teams and as an individual contributor.
- Exceptional verbal and technical writing skills; ability to provide focus and clarity; able to handle confidential information and material appropriately.
- Independently motivated, detail oriented and good problem-solving ability.
- Excellent organizational skills sufficient to multi-task in an extremely fast-paced environment with changing priorities.
- Willingness to take on other tasks as needed to support facility start up.
- Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself.
About Bluebird Bio
About us We are leading the gene therapy revolution. Our integrated product platforms encompass gene therapy, cancer immunotherapy and gene editing – providing us with the potential to treat, and hopefully cure, a broad range of serious diseases. We have a lot of energy, and it’s not just the abundance of coffee that keeps us going. Find out what sparks our excitement and inspires us every day.
Want to learn more about Bluebird Bio? Visit Bluebird Bio's website.
Wholesale’s leading digital marketplace and data exchange