Manager, Instrumentation & Metrology

Humacyte; Durham (NC); On-site; USD 95,000 - 150,000; Full time

Benefits offered by this job

Stock Options

401k Plan with 4% Match and no Vesting

Medical, Vision and Dental Plans

Company Paid Long Term/Short Term Dis

Company Paid Life Insurance

23 Days Paid Time Off (PTO)

10 Company Designated Holidays + 2  "H

Paid Parental Leave Policies

Job summary

Humacyte Inc. in Durham, NC seeks a Metrology and Instrumentation Manager to lead the Site Operations metrology team, ensuring calibrated, reliable GMP/GxP equipment and adherence to safety protocols.

You will drive staffing, performance, and development, partner with Quality, Engineering and Operations, and advance preventive and predictive maintenance programs to support manufacturing. This role requires strong leadership, communication, and a hands-on approach to optimize OEE and equipment

Qualifications

• Associate degree in engineering or related technical field required.
• Bachelor's in electrical engineering preferred or equivalent military training.
• 7 years of metrology, instrumentation or calibration experience.
• Proven leadership experience leading a metrology team.
• Trained in NFPA-70E electrical safety (preferred).
• Experience in a clean room manufacturing environment.

Responsibilities

• Delegate day-to-day activities and motivate the team to meet KPIs.
• Develop team skills in product knowledge and communication.
• Plan tasks and coordinate team execution to meet deadlines.
• Ensure GMP/GLP compliance in equipment maintenance.
• Lead calibrations on GMP and non-GMP equipment.
• Draft calibration procedures and work instructions.
• Collaborate with Quality, Engineering and Operations to improve equipment reliability.
• Maintain calibration standards and vendor documentation.

Skills

Leadership

Metrology

Calibration

GMP/GLP

Electrical Safety NFPA-70E

Communication

Education

Associate’s degree in engineering

Bachelor’s degree in Electrical Engineering

Tools

Electrical testing equipment

Measurement instrumentation

QA documentation tools

Job description

DEPARTMENT: Site Operations

LOCATION: Durham, NC; Onsite/Not Remote

COMPANY: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial opportunity, a portfolio of Acellular Tissue Engineered Vessel (ATEVs), is currently approved for use in vascular trauma repair and is in late-stage clinical trials targeting multiple other applications including AV access for hemodialysis and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma also received the RMAT designation. For more information, visit www.Humacyte.com .

JOB SUMMARY:

• Oversight for Metrology Services by helping to perform calibrations, preventive maintenance activities, general repairs and troubleshooting.
• Delegating tasks to team members, develop and motivate the team to achieve organizational goals and achieve targets.
• Perform all aspects of personnel leadership for the metrology and instrumentation team, to include staffing strategy aligned with corporate objectives, recruitment, performance management, professional development and retention of team members
• Ensuring equipment reliability (OEE) through the development and implementation of routine preventative and predictive metrology programs.
• For leading the team that provides both planned and unplanned support to all pertinent functional areas as it relates to metrology and instrumentation.
• For ensuring that the Metrology department adheres to all compliance requirements.
• This position will be required to be the leader in the day-to-day operations and collaborate and / or assist with the general equipment
• Ensuring observance and adherence to all safety precautions and regulations in all areas where duties are performed by team members.

ESSENTIAL FUNCTIONS:

• Delegate and assign the day-to-day activities of the team members while motivating the team to achieve goals and KPIs
• Empowering team members with skills to improve their confidence, product knowledge, and communication skills
• Responsible for deciding how to approach tasks and develop a plan for the team to accomplish them.
• Partner with Quality, Engineering and Operations groups to always ensure strict compliance with GMP/GLP guidelines, specifically to ensure that the equipment is maintained in GMP/GLP requirements.
• Leads, maintains, and performs basic and advance corrective, preventative maintenance calibrations on GMP & non-GMP equipment and instruments.
• Drafts all calibration procedures needed and assists in the drafting of work instructions for all process and utility equipment.
• Research and provides informed recommendations for instrumentation/metrology spare parts and PM job plans.
• Assists in routing all required documentation for the submittal of spare parts and PM WOs
• Subject Matter Expert (SME) to troubleshoot, test, repair and optimize instruments, equipment, and
• Control system.
• Provides I&C expertise and guidance in the Capital design, appropriation, and installation processes.
• Collaborate with all depts in the continuous improvement efforts within the site Maintenance Program
• Oversee and assist in the maintenance and review of calibration standards and vendor calibration documentation
• Works with contract service providers and supports contractors executing calibration, controls and metrology activities.
• Other duties as assigned.

EXPERIENCE & QUALIFICATIONS:

• Associate’s degree in engineering, Life Sciences or other related technical field required
• Bachelor’s degree in electrical engineering, preferred, or equivalent training from a military environment
• 7 years of applicable Metrology, Instrumentation and/or Calibration experience required
• Proven leadership experience leading a team of Metrology specialists
• Subject Matter Expert in metrology and instrumentation maintenance services to assure equipment reliability in manufacturing, utilities and laboratory environments
• Trained in Electrical Safety NFPA-70E (144 hours of formal instruction on electrical safety is preferred)
• Experience with working in a clean room environment for manufacturing operations and will be required to meet applicable gowning and PPE guidelines
• Required to regulatory sit; stand for prolonged periods of time. May be occasionally required to pull, life and/or move up to 20 pounds
• Excellent communication and interpersonal skills.

COMPENSATION & BENEFITS HIGHLIGHTS:

• 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

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

The statements in this position profile are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time. Humacyte 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.