A-BIO is seeking a Process Engineer to join our team in Maryland. At A-BIO, we differentiate ourselves through owner-side experience and in-depth process and operations knowledge. Our Process Engineers are pivotal in spearheading strategies for complex technical projects in the biopharma sector, working at the forefront of the industry to drive innovation and excellence.
Position Overview
As a Process Engineer at A-BIO, you will be pivotal in advancing biopharmaceutical innovations by leading the entire lifecycle o fmanufacturing processes. In this position, you will collaborate with multidisciplinary teams to design, implement, and validate advanced manufacturing solutions, optimizing facility layouts, process flows, and equipment setups. The Process Engineer will lead various project components, from initial scope development to execution and validation, ensuring alignment with our high standards of quality and efficiency.
Key Responsibilities
Technical Leadership and Execution:
- Develop and oversee project design development and execution focused on the manufacture of biopharmaceutical products
- Manage engineering teams during all project phases
- Lead risk assessments, site selections, and capacity planning efforts
- Develop process control strategies and narratives to translate design intent to automation integrators
- Identify and implement process improvements to enhance yield and operational efficiency
- Process data collection and interpretation to support design and process modeling
- Ensure compliance with project specifications, industry standards, and regulatory requirements
- Participate in CQV execution including FAT/SAT, commissioning, and start-up activities
- Develop and execute CQV protocols
- Coordinate with cross-functional teams that include Validation, Manufacturing, Quality, Supply Chain, and Engineering
- Build and maintain strong relationships with internal teams, clients, and external vendors
- Facilitate project meetings, ensuring effective communication and timely execution of tasks
- Create and manage engineering documentation, ensuring quality and compliance
- Enhance decision-making through effective communication, fostering collaboration and consensus
- Advance your technical subject matter expertise within multiple biopharmaceutical technologies and modalities
- Develop capabilities in capital project management, facility builds, validation lifecycles, quality/regulatory compliance, and client management
- Develop baseline 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
- Minimum of 5 years of experience in the pharmaceutical industry, preferably with a focus on GMP environments
- Understanding of standard process flows in mAb, gene therapy, or cell therapy production
- Subject Matter Expertise in at least one biopharma manufacturing modality
- 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
- 8 years of engineering experience within a cGMP-regulated industry
- Familiarity with automation and control systems
- Subject Matter Expertise in at least two biopharma manufacturing modalities
- Experience with design, start-up, shutdowns, return to service, and troubleshooting of manufacturing systems
- Strong project management skills, with prior capital project experience
