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Instrumentation & Metrology Specialist 3 at Humacyte Inc

Instrumentation & Metrology Specialist 3

Humacyte Inc Durham, NC Full-Time
Humacyte, Inc. is proud to be a vaccinated workplace where all employees are expected to be fully vaccinated against COVID-19. Proof of full vaccination is required before beginning work. Humacyte will provide accommodations as required by law.

Humacyte, Inc. is bringing to market a once in a generation scientific technology platform, bioengineering readily available and universally implantable product opportunities focused on improving lives of patients and transforming the practice of medicine. Located in Durham, NC, the company develops and manufactures acellular tissues for the treatment of diseases and conditions across a wide range of therapeutic areas. The company's innovative technology supports tissue repair, reconstruction, and replacement while overcoming limitations in existing standards of care. Initially developing a portfolio of human acellular vessels (HAVs), to target multiple vascular markets including trauma, arteriovenous access for hemodialysis, peripheral arterial disease, and coronary artery bypass grafting. Humacyte is focused on the development of future markets such as pediatric heart surgery, delivery of cellular therapies, and multiple other novel cell and tissue systems.

We are looking for additional colleagues to continue to build our expanding team. Candidates will be expected to work both independently and collaboratively as part of the Humacyte organization. Applicants must be highly self-motivated, with solid communication skills, and demonstrates the ability to work in a team environment and lead other professionals and peers.

Position Background:

The Instrumentation & Metrology Specialist 3 will provide metrology, instrumentation and controls knowledge and expertise for manufacturing, utility & laboratory equipment throughout Humacyte site. Though the primary duties of this position will center on instrument calibration and equipment controls support, the position may be required to collaborate and / or assist with the general equipment and facilities maintenance group. The ideal candidate will display an advanced knowledge of GMP equipment instrumentation and controls, willingness, and expertise to assist with general maintenance, and the ability to collaborate with other departments, as needed.

This position reports to Senior Manager, Metrology & Instrumentation Services

Remote Work Designation: Not Remote

Major Accountabilities:

* Partner with Quality, Engineering and Operations groups to ensure strict compliance with GMP/GLP guidelines at all times, 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
* Site Subject Matter Expert to troubleshoot, test, repair and optimize instruments, equipment, and control systems
* 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 assists in the maintenance and review of calibration standards and vendor calibration documentation
* Works with contract service providers and support contractors executing calibration, controls and metrology activities
* Other duties, as assigned

Special Competencies:

* Advance understanding and application of instrument, equipment, and loop calibrations of various parameters in manufacturing, utilities, and laboratory environments
* Proven knowledge and understanding of electrical panels and electrical safety procedures
* Advance understanding of Traceability, Substitution of Standards, and Test Accuracy and Uncertainty Ratios. Skilled with pneumatic, mechanical, and electrical instrumentation; as well as manual and computer-based process control loops and systems; understands and applies basic concepts of calibration and requirements including accuracy testing. Advance understanding and application of instrument, equipment, and loop calibrations of various parameters in manufacturing, utilities, and laboratory environments
* General electrical panel knowledge and electrical safety procedures
* Able to make independent decisions within defined scope of work, seeks clarification and directions when needed. Must be self-driven and demonstrate ability to work with little direction.
* Advance knowledge of calibration and controls disciplines within a cGMP Biotechnology/pharmaceutical manufacturing environment, required
* Demonstrated knowledge of DCS, PLC, and/or Building Automation Systems (BAS) control systems, required
* Advance experience with basic problem solving and troubleshooting I&C systems in a pharmaceutical environment
* Proven knowledge of a Computerized Maintenance Management System (CMMS)
* Strong organizational and planning skills required
* Excellent interpersonal effectiveness and communication skills (written and oral) are required to interface across management levels and departments

General Competencies:

* Able to communicate effectively in English, both verbally and in writing

* Possess a positive roll-up-the-sleeves attitude and optimistic outlook

* Represents the organization in a positive and professional manner

* 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

* Reports to work on time and as scheduled

* Works as a team player, and serves as a model by participating in activities that involve cooperating with others

QUALIFICATIONS:

* Associates Degree in Engineering, Life Sciences or other related technical field, required. Bachelor's Degree in Electrical Engineering, preferred, or equivalent military training
* 7 years of applicable Metrology, Instrumentation or Calibration experience, required
* 7 years of Quality System/Pharmaceutical experience is preferred
* Instrumentation Technical Training Certificate (ISA-CCST) or equivalent preferred
* Trained in Electrical Safety NFPA-70E (144 hours of formal instruction on electrical safety, electrical system, electronics) preferred
* Will spend time in a clean room environment for manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines
* Will be required to regularly to sit; stand for prolonged periods of time. Also may occasionally be required to pull, lift and/or move up to 20 pounds
* Position may require working holidays, weekends and over-time

Perks:

* 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 sponsorship at this time.

Recommended Skills

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