A-BIO is seeking a Project Engineers to join our team in Maryland. At A-BIO, we differentiate ourselves through owner-side experience and in-depth process and operations knowledge. Our Project Engineers serve in multi-faceted roles taking on key responsibilities to ensure projects are delivered effectively.
Position Overview
As a Project Engineer at A-BIO, you will be pivotal in advancing biopharmaceutical innovations through your support of pivotal projects within the biopharma space. In this position, you will collaborate with multidisciplinary teams across all project stages, including design, preconstruction, construction, CQV, and operational readiness. A-BIO Project Engineers are masters of adaptation taking on new tasks and responsibilities as project needs develop over time.
Key Responsibilities
Technical Leadership and Execution:
- Manage or provide project support across all project phases
- Ensure compliance with project specifications, industry standards, and regulatory requirements
- Develop and execute field plans for construction, contractor oversight, and other project activities
- Field survey and data collection supporting engineering projects / initiatives
- Facilitate and participate in design review
- Participate in CQV execution including FAT/SAT, commissioning, and start-up activities
- Develop and execute CQV protocols
- Management and delivery of contractor turnover packages
- Engineering drawing management for redline, revision, etc.
- Coordinate with cross-functional teams that include Validation, Manufacturing, Quality, Supply Chain, andEngineering
- Build and maintain strong relationships with internal teams, clients, and external vendors
- Facilitate project meetings, ensuring effective communication and timely execution of tasks
- Develop capabilities in capital project management, facility builds, validation lifecycles, quality/regulatory compliance, and client management
- Develop knowledge and capabilities in project management
- Engage in ongoing learning within the life sciences to remain at the cutting edge of the industry
Minimum Qualifications
- Bachelor of Science in Engineering
- Experience in pharmaceutical industry, preferably with a focus on cGMP environments
- Project Engineer I – 2 years
- Project Engineer II – 4 years
- Project Engineer III – 8 years
- Sr. Project Engineer – 10 years
- Demonstrated capability in leading technical project scopes
- In-depth knowledge of engineering principles, GMP requirements, and industry best practices
- Excellent communication skills, both verbal and written
- Proven ability to manage time effectively and prioritize tasks
Beneficial Qualifications
- Understanding of standard process flows in mAb, gene therapy, or cell therapy production
- Familiarity with automation and control systems
- Experience with design, start-up, shutdowns, return to service, and troubleshooting of manufacturing systems
- Strong project management skills, with prior capital project experience
