Humacyte Global, Inc.
Durham, NC, USA
Apr 24, 2024
Full time
Position Background:
The Automation Engineer 2 is responsible for supporting any existing and new project automation systems at Humacyte, an FDA regulated site. This includes daily verifications required for data integrity requirements and modifications to the system configuration as required for process, building or historian automation requirements. There is an expectation that the employee will have a primary system responsibility, either DeltaV, PLC, BAS, or PI focused, but will be able to support all automation system as required .
Remote Work Designation : Not Remote
Major Accountabilities:
Utilizing current engineering skills and knowledge, provide routine automation expertise for the development of custom commercial manufacturing equipment for a human acellular vessel product with the guidance and direction of more senior team members and/or manager
Support and maintain existing PI data historian in existing manufacturing and R&D facilities
In collaboration with Senior Automation Engineer and/or Associate Director, Automation, support the installation and validation of a PI data historian for the commercial manufacturing facility
Support the installation and validation of a DeltaV system for the commercial manufacturing process
Support the installation and validation a building automation system for the commercial manufacturing facility
Support the installation and validation of OEM and custom PLCs for the commercial manufacturing process
Assist process development team in testing prototype equipment and by independently developing automation for custom research and development equipment
Promote transparency around process development activities through routine internal updates to direct manager and/or cross-functional colleagues
Support and troubleshooting automation during development, technology transfer, and commercial manufacturing
Perform thorough system tests to ensure robustness of custom automation
Assist in oversight in transition of automated equipment to comply with regulatory and quality control requirements
Assist in the development of automation documentation, including functional requirements, design documents, test protocols, SOPs and reports
Respond to automation-based alarms during standard office hours and as on-call support, as required
Support regulatory filings as required
Other duties, as assigned
Special Competencies:
Demonstrated knowledge and understanding of developing and supporting automation for commercial manufacturing processes
Familiarity with automation of bioprocess applications in GMP facility
Familiarity and understanding of basic and/or advanced cGMP compliance in the biotech/bioprocessing manufacturing environment
Knowledge of Code of Federal Regulations 21 CFR 1271 a plus
Detail-oriented, self-motivated and scientifically driven
Strong analytical and problem-solving skills
Strong knowledge of GMP quality systems
Excellent communication and interpersonal skills
General Competencies:
Able to communicate effectively in English, both verbally and in writing
Excellent communication and interpersonal skills
Possess a positive roll-up-the-sleeves attitude and optimistic outlook
Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
Excellent organizational and time management skills with ability to set own priorities in a timely manner
High degree of flexibility and adaptability
Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
Must be able to work as needed to meet tight deadlines and at peak periods
Self-motivated and organized critical thinker with solid interpersonal and business communication skills
Demonstrated ability to work in a cross functional team
Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
Always observe safety precautions and regulations in all areas where duties are performed
Responsible for reporting all safety hazards and potential unsafe working conditions
Ensures Humacyte or other required trainings/certifications are up to date
Represents the organization in a positive and professional manner
Reports to work on time and as scheduled
Qualifications:
BS in Mechanical Engineering, Electrical Engineering, Chemical Engineering, or similar field, required
At least 3 years of industry experience in process and equipment automation
At least 3 years of relevant pharma or biotech industry experience
Experience with automation platforms including Allen-Bradley PLC, DeltaV DCS, Beckhoff TwinCAT PLC and/or Johnson Controls
Experience installing and/or supporting PI historian system
Background in Automation, Electrical Engineering or Mechanical Engineering
Knowledge and experience with standard bioprocessing skills as well as use and maintenance of common laboratory procedures and equipment
Will spend time in a clean room environment for manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines