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

Ready to Apply? Please submit resumes to hr@a-bio.com

AllianceBio

New Jobs

Project Engineer (Multiple Levels)