- 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 calibration on GMP and 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 departments in the continuous improvement efforts within the site maintenance program.
- Oversees and assists in the maintenance and review of calibration standards and vendor calibration documentation.
- Works with contract service providers and support contractor executing calibration, controls and metrology activities.
- Other duties as assigned.
- Associates Degree in Engineering, Life Sciences or other related technical field, required.
- Bachelor's 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 systems, 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 overtime.
- 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.
-
Quality Specialist III
3 weeks ago
HUMACYTE GLOBAL INC Durham, United StatesJob Description · Job DescriptionJOB TITLE: Quality Specialist IIIDEPARTMENT: Quality · LOCATION: Durham, NC, Onsite/Not Remote · COMPANY: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues ...
-
Learning & Development Specialist III
1 week ago
Toshiba Global Commerce Solutions Durham, United StatesGenerally, the Learning & Development Specialist III will support and help to continuously improve our employee experience with Learning & Development at Toshiba. Provide support of the learning content in our knowledge and learning platform as well as assist with related content ...
-
Instrumentation & Metrology Specialist III
4 weeks ago
HUMACYTE GLOBAL INC Durham, United StatesJob Description · Job DescriptionThe Instrumentation and Metrology Specialist III will provide metrology, instrumentation and controls knowledge and expertise for manufacturing, utility and laboratory equipment throughout the Humacyte site. Though the primary duties of this posit ...
-
EHS&S Specialist III
3 weeks ago
KBI Biopharma Durham, United StatesThe specialist has responsibility for the implementation of the environmental, health, safety, and sustainability (EHS&S) program. This includes leadership to maintain EHS&S compliance and continuous improvement. EHS&S supports operations of biologic contract development and manu ...
-
Clinical Data Specialist III
1 week ago
Duke University Durham, United StatesWorks with clinical research team members, including P - Is, study coordinators, data analysts, and biostatisticians, to ensure that all aspects of the data management process are executed efficiently and accurately. Leads day-to-day operations of ma Data Specialist, Clinical, Cl ...
-
Clinical Data Specialist III
1 week ago
Duke University Durham, United StatesSchool of Nursing Established in 1931, Duke University School of Nursing is among the top-ranked of the nation's nursing schools. The school is proud of its overarching commitment to educating the next generation of nurse leaders and advancing the roleof nurses and nursing in the ...
-
Biogen Durham, United StatesJob Description · Shift Information? · This position will work a 2,2,3 schedule working the 12-hour Night Shift. · About the Job? · A Manufacturing Process Maintenance Specialist III will provide customer-oriented service and support in a fast-paced manufacturing environment. ...
-
Manufacturing Specialist III, MFG Tech Ops
1 week ago
Biogen Durham, United StatesJob Description · About this Role · In this Small Scale Manufacturing (SSM) Manufacturing Specialist III role, you will be responsible for manufacturing support tasks including technical writing, project management, and process implementation. This position requires you to be hig ...
-
IT Site Services Specialist III
1 month ago
Charles River Laboratories, Inc. Durham, United StatesFor 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your backgr ...
-
Sales Operations Support Specialist III
3 weeks ago
Toshiba Durham, United States Full timeToshiba Global Commerce Solutions is seeking a Sales Operations Support Specialist III position supports all commercial related activities for our Direct Accounts and Business Partners including, but not limited to, pricing proposals, contract creation, deal and SOW support and r ...
-
Behavioral Health Specialist III
6 days ago
RHA Health Services Burlington, United StatesWe are hiring for:Behavioral Health Specialist III (QP) (BH), TMSType:RegularIf you are a positive and personable individual looking for a satisfying and fun opportunity to make a real difference in the lives of people with intellectual, developmental disabilities, and people fac ...
-
Lending Operations Specialist III
2 weeks ago
FIRST FLIGHT FEDERAL CU Cary, United StatesJob Description · Job DescriptionSUMMARY: · This position is responsible for the mortgage post-closing servicing of First Flight. Responsible for processing mortgage payoffs and escrow payments (taxes and insurance). Responsible for processing satisfaction of Deeds of Trusts to t ...
-
Clinical Documentation Specialist III
2 weeks ago
Tufts Medicine Burlington, United StatesWe're saving lives, building careers, and reimagining healthcare. We can't wait to grow alongside you. · **Job Profile** · **Summary** · ?This role focuses on activities related to revenue cycle operations such as billing, collections, and payment processing. · In addition, thi ...
-
Procurement Specialist III Resins
3 weeks ago
Thermo Fisher Scientific Morrisville, United StatesScale of Responsibilities Implements global category initiatives to deliver key category performance indicators, including: savings, supplier rationalization, low-cost region sourcing, risk management, spend under agreement, joint innovation, supplie Continuous Improvement, Procu ...
-
Manufacturing Specialist III, Mfg Tech Ops
1 month ago
Biogen Idec Research Triangle Park, United StatesCompany DescriptionJob Description · About this Role · In this Small Scale Manufacturing (SSM) Manufacturing Specialist II role, you will be responsible for manufacturing support tasks including technical writing, project management, and process implementation. This position requ ...
-
New Graduate Registered Nurse
1 week ago
VCU Health South Hill, United States Full time**$10,000 Sign On Bonus for offers accepted by June 30, 2024. Terms and Conditions apply** · Community Memorial Hospital (CMH) is a 70-bed facility located in the heart of South Central Virginia serving residents of over 7 counties, including North Carolina due to its location ju ...
-
Pharmacy Technician III-Training Coordinator
18 hours ago
Duke Health Durham, United States RegularPharmacy Technician III-Training Coordinator · Work Arrangement: Requisition Number: Regular or Temporary: Regular Location: Durham, NC, US, 27710 · Personnel Area: DUKE HOSPITAL Date: Jun 13, 2024 At Duke Health, we're driven by a commitment to compassionate care that changes ...
-
Clinical Coordinator
3 weeks ago
North Carolina Central University Durham, United StatesThe Julius L. Chambers Biomedical/Biotechnology Research Institute (BBRI) is a 40,000 sq. ft. state-of-the-art research facility that is dedicated to expanding the University's research capacity, particularly in the biomedical and biotechnology areas. The BBRI is a broad based mu ...
-
Exercise Specialist
2 days ago
Duke University Durham, United States Part timeGeneral Description of the Job Class · The Duke Health and Fitness Center is seeking a highly qualified exercise specialist to join our team. Responsibilities include to provide safety for clinical members during exercise sessions and to triage symptoms and vitals for members pr ...
-
Instrumentation & Metrology Specialist II
3 weeks ago
Humacyte Inc Durham, United StatesThe Instrumentation and Metrology Specialist II will provide metrology, instrumentation and controls knowledge for the manufacturing utility and laboratory equipment throughout the Humacyte site. Though the primary duties of this position will center on basic instrument calibrati ...
Instrumentation & Metrology Specialist III - Durham, United States - Humacyte Inc
![Default job background](https://contents.bebee.com/public/img/bg-user-ex-1.jpg)
Description
The Instrumentation and Metrology Specialist III will provide metrology, instrumentation and controls knowledge and expertise for manufacturing, utility and laboratory equipment throughout the 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.
Major Accountabilities