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 are looking for driven individuals who want to grow their expertise, help us expand, and contribute to improving the lives of patients worldwide. If you are ready to be part of a team that values growth, collaboration, and meaningful work, we would love to hear from you!
About A-BIO
A-BIO is an owner's representative consulting firm focused on project management and technical services within the technical operations of biopharmaceutical development and manufacturing. Our clients range from start-up cell and gene therapy companies to multi-national major pharmaceutical companies, with projects spanning the construction, retrofit, and operations of biopharmaceutical manufacturing facilities. A-BIO has been serving the life sciences sector since 2014, leveraging decades of owner's-side experience to identify the right resources and expertise to support client needs — from concept through operational readiness.
Position Overview
As an Automation Engineer / Automation Project Manager at A-BIO, you will be at the intersection of two critical disciplines — deep technical expertise in industrial automation and controls, and the project leadership skills to drive complex initiatives from concept through commissioning in cGMP-regulated environments.
In this role, you will serve as A-BIO's owner's representative on client engagements, bridging the gap between process needs and automation design. You will work directly with client teams across Manufacturing, Engineering, Validation, and Facilities while managing system integrators, vendors, and contractors to ensure project delivery meets the highest standards of quality, compliance, and performance. Whether leading a full automation project lifecycle or providing embedded technical support to a client's internal team, you will bring both hands-on controls knowledge and a project manager's discipline to every engagement.
This position supports client projects in the Maryland area, with the opportunity to work across diverse biopharma modalities including mAbs, gene therapy, cell therapy, and vaccines.
Key Responsibilities
Automation Project Management
- Lead or support automation projects through all phases — conception, design, implementation, qualification, and operational readiness —ensuring alignment with client goals and cGMP requirements.
- Develop automation project and user requirements in close collaboration with client personnel across Automation, Manufacturing, Engineering, Validation, and Facilities groups.
- Perform project management and controls functions: define scope, develop and manage schedules, track budgets, manage risk registers, and report project status to client leadership and stakeholders.
- Serve as owner's representative — manage system integrators, vendors, and contractors, ensuring deliverables meet technical, quality, and schedule requirements.
- Enforce A-BIO and client standards for automation engineering across all contractor and integrator activities.
- Partner with selected integrators to establish project execution governance including team structure, RACI, meeting cadence, and project execution plans.
- Facilitate project team meetings, drive effective communication, and manage cross-functional teams including resources without a direct reporting relationship.
- Proactively identify project risks and issues, devise mitigation strategies, and escalate critical concerns to stakeholders when necessary.
Automation Technical Services
- Effectively translate process and cGMP manufacturing needs and best practices into automation design, serving as the liaison between client technical teams and system integrators.
- Specify automation hardware and software — including PLCs, DCS platforms, HMIs, SCADA systems, instrumentation, VFDs, and communication networks — ensuring alignment with site standards.
- Review, author, and manage automation documentation including Functional Requirements Specifications (FRS), Software Design Specifications (SDS), control narratives, User Requirements Specifications (URS), and system architecture documents.
- Support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT), startup, commissioning, and qualification activities for automated process and utility equipment and control systems.
- Oversee contractors during field installation of network, automation, and instrumentation systems.
- Provide troubleshooting and automation support to client user groups; manage deviation and nonconformance responses related to automation systems.
- Define and manage hardware and code deployment strategies including downloads, merges, loop checks, and code change management.
CSV & Compliance
- Define GMP compliance and data integrity standards in alignment with client site requirements and industry expectations.
- Develop and implement Computer System Validation (CSV) approaches and strategies; ensure CSV activities are incorporated into project schedules.
- Own automation change management tasks through the project lifecycle, including authoring and managing change controls in accordance with client standards.
- Ensure strict adherence to project specifications, industry standards, and regulatory requirements throughout all project phases.
Leadership & Growth
- Interface with client senior management and external partners to represent A-BIO and client interests.
- Lead and mentor junior engineers; contribute to A-BIO's technical knowledge base and delivery standards.
- Develop and enhance capabilities across project management, CQV, regulatory compliance, and client relationship management.
- Stay at the forefront of automation technology and industry trends, leveraging knowledge to deliver innovative solutions and exceptional project outcomes.
Minimum Qualifications
- Bachelor's degree in Electrical Engineering, Chemical Engineering, Mechanical Engineering, Computer Engineering, or a related engineering discipline; or equivalent combination of education and demonstrated experience.
- Minimum of 5 years of automation/control system engineering or project management experience in a cGMP-regulated industry (biopharmaceutical, pharmaceutical, or related life sciences).
- Demonstrated interest in both the process and automation sides of biopharmaceutical cGMP manufacturing.
- Knowledge of project management methodologies and principles; ability to manage and integrate technical and non-technical project scopes of varying size and complexity.
- Ability to manage multiple projects simultaneously, coordinate cross-functional efforts, and review and interpret engineering and design documents.
- Ability to work both independently and collaboratively on project deliverables.
- Willingness and ability to travel to client sites in the Maryland area based on project location.
- Strong written and verbal communication skills; excellent documentation and organizational skills.
Beneficial Qualifications
- 10+ years of automation engineering or project management experience in a cGMP-regulated biopharmaceutical environment.
- Prior experience in the design, configuration, start-up, or troubleshooting of industrial control systems including PLCs, DCS platforms, HMIs, SCADA systems, SQL databases, historians, instrumentation, VFDs, and communication networks.
- Experience with Allen-Bradley ControlLogix PLCs, Emerson DeltaV, Wonderware (AVEVA), and/or Siemens Apogee Building Management Systems.
- Experience with virtual computing environments, OPC (OPC-DA / OPC-UA), OSI PI, or GE Proficy platforms.
- Working knowledge of control panel design, installation standards (NEC, NFPA 79), and field wiring practices.
- High-level understanding of standard process flows in mAbs, gene therapy, or cell therapy production.
- Capital project management experience; PMP certification or equivalent is a plus.
- ISA Certified Automation Professional (CAP) or CSIA certification is a plus.
- Active engagement in biopharmaceutical industry organizations, reflecting a commitment to professional growth and staying informed on industry trends.
Core Competencies
- Technical Engineering
- PLC / DCS / SCADA / HMI configuration
- Allen-Bradley ControlLogix & Emerson DeltaV
- Wonderware (AVEVA) / Siemens Apogee BMS
- Instrumentation, VFDs & control networks
- Control panel design & field wiring
- OPC, OSI PI, SQL historians
- CSV / data integrity standards
- Commissioning, CQV & change management
- Project & Program Management
- cGMP project lifecycle management
- Owner's representative / vendor oversight
- Scope, schedule & budget control
- FAT / SAT planning & execution
- Cross-functional team coordination
- Risk identification & mitigation
- Stakeholder & client communication
- Technical documentation (URS/FDS/IOQ)
Why A-BIO?
- Work on high-impact, diverse projects across the biopharmaceutical and life sciences sector — an industry where your work directly supports the development and manufacturing of critical therapies for patients worldwide.
- Access A-BIO's team of process engineering, automation, and project management experts, with over 200 years of combined biopharma operations and capital project experience.
- Exposure to cutting-edge modalities including gene therapy, cell therapy, mRNA, recombinant proteins, and vaccines across a variety of client environments.
- Collaborative, owner's-side culture that values technical depth, professional growth, and meaningful client relationships.
- Competitive compensation, comprehensive benefits, and professional development and certification reimbursement.
Work Environment
- Client site environments including biopharmaceutical manufacturing facilities, cleanrooms, mechanical and utility areas, and laboratories; PPE required where applicable.
- Regular travel to client sites in Rockville, Frederick, and Baltimore, MD; occasional travel to vendor or contractor facilities for FAT and related activities.
- May require flexible hours during commissioning, startup, or critical project milestones.
