Bioprocessing Engineer for Global Innovation

2 days ago

Durham, North Carolina, United States HUMACYTE GLOBAL INC Full time

Job Summary

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We are seeking a skilled Bioprocessing Engineer to join our team at HUMACYTE GLOBAL INC in Durham, NC. As a key member of our operations team, you will be responsible for ensuring the smooth operation of our bioprocessing equipment and systems.

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About the Role

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The Senior Process Engineer will provide engineering expertise in Bioprocessing manufacturing equipment and systems to support manufacturing operations with limited supervision and guidance. Your primary duties will include executing equipment checks, engineering tests, and troubleshooting activities to evaluate instrument/equipment performance, capabilities, issues, optimizations, and improvements within applicable procedures.

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Your Key Responsibilities

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  • Serves as the engineering expert in HAV production systems; able to fully understand the manufacturing process, automation and engineering controls, to proactively consider solutions to potential problems
  • Leads and performs hands-on testing/troubleshooting for advanced corrective/preventative maintenance and optimization of HAV manufacturing equipment, control systems, and instrumentation
  • Schedule equipment checks and maintenance activities for Bioprocessing equipment with the equipment/area owners to ensure production schedules are maintained
  • Drafts corrective and preventative maintenance work instructions for Bioprocessing equipment
  • Investigate, identify root cause, and identify CAPA for bioprocessing deviations related to equipment performance
  • Identify continuous improvement opportunities in terms of cost savings, process robustness, and manufacturing efficiency gains
  • Work with equipment manufacturers to procure repairs, spare parts and scheduled maintenance of HAV manufacturing systems and equipment
  • Document work utilizing site's Computerized Maintenance Management System (CMMS)
  • Assist in equipment selection, qualification, and start up activities.
  • Work with Bioprocessing to ensure robust procedures are utilized for operation of equipment
  • For new equipment, is responsible for ensuring that the design requirements align with process, user, and functional requirements
  • For new equipment, may participate and/or be responsible for factory acceptance testing (FAT), site acceptance testing (SAT), and Design Qualifications
  • Collaborate as reviewer or approver of Validation protocols for equipment commissioning operations and equipment functional specifications created by Automation.
  • Other duties, as assigned
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What You Will Need

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To succeed in this role, you will need:

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  • An Associate's degree in engineering, Life Sciences or other related technical field, required. Bachelor's Degree in Engineering, preferred, or equivalent military training
  • At least 8 years of prior work experience in maintaining Bioprocessing production systems and equipment under cGMP regimen
  • Hands-on troubleshooting and corrective action implementation with a broad range of Bioprocessing systems
  • Experience directing work of trade personnel and/or outside contractors
  • Experience in the installation and troubleshooting of complex Bioprocessing systems
  • Strong experience working cross functionally within a BioPharma Bioprocessing organization
  • Experience leading projects related to, process optimization, technical troubleshooting, and bioprocessing equipment changes
  • Majority of work will be performed in clean room environment to provide process engineering assistance to manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines
  • Highly motivated and organized
  • Works and leads well in a team environment Experience with electrical, pneumatic, mechanical, and instrumentation; as well as manual and computer-based process control loops and systems required
  • 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 demonstrated ability to collaborate within cross functional teams.
  • Excellent organizational and time management skills with ability to set own priorities in a timely manner.
  • High degree of flexibility and adaptability.
  • Self-motivated and organized critical thinker with solid interpersonal and business communication skills.
  • Represents the organization in a positive and highly professional manner.
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Benefits

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  • $120,000 - $150,000 per year salary depending on experience
  • Stock Options
  • 401k Plan with 4% Match and no Vesting Schedule
  • Medical, Vision and Dental Plans
  • Company Paid Long Term/Short Term Disability
  • Company Paid Life Insurance
  • 23 Days Paid Time Off (PTO)
  • 10 Company Designated Holidays + 2 Floating Holidays
  • Paid Parental Leave Policies
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About Us

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Humacyte does not provide U.S. employment sponsorship and does not accept unsolicited resumes from 3rd party firms and/or agency recruiters.

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HUMACYTE GLOBAL INC is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, Humacyte is committed to achieving its business objectives in compliance with all federal, state and local law.

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Salary: $120,000 - $150,000 per year depending on experience

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