Are you ready to take your career to the next level?
Join a company where your skills and passion can make a real difference. At A-BIO we’re looking for driven individuals who want to grow their expertise, help us expand, and contribute to improving the lives of patients worldwide. If you’re ready to be part of a team that values growth, collaboration, and meaningful work, we’d love to hear from you!
Position Overview
As a Process Engineer in our Maryland office, you will be at the forefront of innovation in the biopharmaceutical industry. In this pivotal role, you will participate in the entire lifecycle of manufacturing processes—from initial conception to validation to optimization—ensuring our solutions meet the highest standards of quality, efficiency, and performance.
You will collaborate with multidisciplinary teams to design, implement, and optimize state-of-the-art manufacturing systems. Your responsibilities will include improving facility layouts, streamlining process flows, and configuring equipment setups to maximize quality and productivity. By overseeing key project phases—such as scope development, execution, and validation—you will be a critical contributor in driving transformative advancements in our client’s manufacturing operations.
Key Responsibilities
- Lead the design, development, and execution of projects focused on biopharmaceutical manufacturing processes, ensuring alignment with organizational and client objectives.
- Manage and oversee engineering teams through all project phases, including planning, design, execution, and closeout.
- Conduct and lead risk assessments, site selection analyses, and capacity planning assessments.
- Develop detailed process control strategies and narratives to communicate design intent to automation integrators.
- Identify, evaluate, and implement process improvements to enhance yield, operational efficiency, and overall manufacturing performance.
- Collect, analyze, and interpret process data to support design development and process modeling efforts.
- Ensure strict adherence to project specifications, industry standards, and regulatory requirements throughout the project lifecycle.
- Participate in Commissioning, Qualification, and Validation (CQV) activities, including Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), commissioning, and start-up.
- Develop and execute detailed CQV protocols to ensure systems and processes meet operational and regulatory requirements.
- Collaborate with cross-functional teams, including Validation, Manufacturing, Quality, Supply Chain, EHS, and Engineering, to drive project success.
- Foster and maintain strong relationships with internal teams, clients, and external vendors to ensure seamless project execution.
- Facilitate project meetings, driving effective communication, task alignment, and timely decision-making.
- Prepare, review, and manage engineering documentation to ensure quality, accuracy, and compliance with industry standards.
- Support decision-making by fostering collaboration, consensus, and transparent communication among stakeholders.
- Advance your technical expertise across multiple biopharmaceutical technologies and modalities, staying at the forefront of industry trends.
- Develop and enhance your capabilities in project management, capital project delivery, facility construction, validation lifecycles, quality/regulatory compliance, and client relationship management.
- Commit to continuous professional development by engaging in ongoing learning within the life sciences, maintaining industry-leading expertise.
Minimum Qualifications
- Bachelor’s degree in engineering or a related field.
- At least 5 years of experience in the pharmaceutical or biopharmaceutical industry, with a strong focus on GMP (Good Manufacturing Practice) environments.
- Understanding of process flows in monoclonal antibody (mAb), gene therapy, or cell therapy production.
- Expertise in at least one biopharmaceutical manufacturing modality.
- Ability to lead technical project scopes, including design, execution, and validation phases.
- Strong knowledge of engineering principles, GMP requirements, and industry best practices.
- Excellent verbal and written communication skills, with the ability to convey complex technical concepts to diverse audiences.
- Skilled in managing time effectively, prioritizing tasks, and meeting deadlines in a fast-paced environment.
- Flexibility and willingness to travel within Maryland as required based on project locations and client needs.
Beneficial Qualifications
- 8 years of engineering experience in a cGMP-regulated industry, with a thorough understanding of regulatory requirements and industry standards.
- Proficiency in automation and control systems, including hands-on experience within manufacturing environments.
- Deep knowledge in at least two biopharmaceutical manufacturing modalities, such as mAb, gene therapy, or cell therapy.
- Experience in designing, starting up, shutting down, returning to service, and troubleshooting biopharmaceutical manufacturing systems.
- Proven project management skills, with experience in capital projects.
- Willingness to travel within the United States as required based on project locations and client needs.
