Automation Engineer II

Automation Engineer II

Position Background:

The Automation Engineer 2 is responsible for supporting any existing and new project automation systems; 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, Client, 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