Engineering Jobs in Garner North Carolina

Job Summary

The Director / Senior Director / Executive Director, CMC Regulatory Affairs is responsible for leading global regulatory CMC development, registration, and compliance activities from early development through commercialization. This role reports to the Head of Global Regulatory Affairs and may be based on-site or remote, depending on organizational needs. The position plays a critical role in defining and executing global CMC regulatory strategies in alignment with business and development objectives.

Key Responsibilities

Regulatory Strategy & Leadership

• Lead the development and execution of global CMC and device regulatory submission strategies in close collaboration with cross-functional project teams.
• Review CMC content and manage submission timelines to ensure alignment with business objectives.

Regulatory Compliance & Guidance

• Assess and communicate global CMC and device regulatory requirements to ensure development activities comply with applicable regulations and guidelines.
• Maintain current knowledge of evolving global CMC and device regulatory regulations, standards, and guidance, and communicate impact to stakeholders.

Quality by Design (QbD) & Risk Management

• Partner with CMC and technical teams to develop and document Quality by Design (QbD) strategies for novel manufacturing processes.
• Conduct risk assessments and develop mitigation strategies for global CMC and device regulatory matters.

Regulatory Submissions & Agency Interactions

• Lead preparation and review of CMC sections for regulatory submissions, including INDs, CTAs, IMPDs, NDAs, MAAs, supplements, annual reports, amendments, and regulatory correspondence.
• Prepare and coordinate responses to regulatory authority information requests during application review and post-approval maintenance.
• Serve as a primary regulatory interface with health authorities on CMC and device-related matters, including leading preparations for regulatory agency meetings.

Manufacturing & Inspection Readiness

• Collaborate closely with Manufacturing, Quality, and external partners to support GMP facility inspections and regulatory audits.
• Assess CMC-related and device changes and ensure timely and compliant reporting to global health authorities.

Cross-Functional Collaboration

• Work closely with Manufacturing, Quality, R&D, and external vendors to support development programs, commercialization activities, and lifecycle management.
• Communicate complex CMC strategies, novel manufacturing processes, and QbD activities clearly and effectively to internal stakeholders and regulatory agencies.

Education & Experience

• Bachelor’s degree in Chemistry, Biochemistry, Engineering, Life Sciences, or a related discipline required; advanced degree preferred.
• RAC or similar regulatory certification is a plus.
• Minimum experience requirements by level:
• Director: 10+ years of CMC regulatory or related pharmaceutical industry experience
• Senior Director: 12+ years
• Executive Director: 15+ years
• Demonstrated ability to define and execute global CMC regulatory strategies with minimal oversight.
• Strong understanding of drug development and lifecycle management, including interdependencies across functions.
• Small molecule experience preferred.
• Experience with pharmaceutical Quality by Design (QbD) concepts and implementation.
• In-depth knowledge of FDA and ICH regulations and guidelines, with experience serving as an FDA liaison; familiarity with EU and other global regulatory requirements preferred.
• Proven experience authoring and submitting INDs, CTAs, IMPDs, NDAs, MAAs, and supplements.
• Experience supporting post-market and commercialization CMC regulatory activities.

Why start your new career with flyExclusive:

FlyExclusive is a dynamic and growing company with a strong commitment to safety, service, and excellence. As a member of our team, you will have the opportunity to work with state-of-the-art aircraft and advanced technologies, providing you with valuable experience and career development opportunities. We offer a competitive salary and benefits package, as well as a supportive and collaborative work environment. Join us at flyExclusive and take your career to new heights!

Summary and Objective

A&P Licensed Maintenance Controllers communicate directly with pilots regarding Aircraft Airworthiness and facilitate maintenance support when needed. The Maintenance Control Center (MCC) monitors all aspects of the maintenance process from AOG (Aircraft on Ground) to RTS (return to service).

Essential functions

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

• Communicates with Operations and advises of aircraft maintenance status changes.
• Coordinates maintenance operation issues on the Cessna Citation series aircraft.
• Ensure accurate and timely information is conveyed using Avianis/CAMP and Corridor systems.
• Evaluate reported aircraft discrepancies and develop an appropriate recovery plan.
• Ensures all aircraft that are down for maintenance are repaired safely, per OEM and Regulatory Instruction and in a timely manner.
• Evaluate reported aircraft discrepancies and develop an appropriate recovery plan.

Skills and Abilities:

• Must be able to work in a fast paced, occasionally stressful environment
• Ability to work weekends/holidays/possibly on call if needed
• Ability to read wiring diagrams and troubleshoot electrical circuits.
• Being a self-starter who is highly motivated with strong initiative
• Interpersonal skills with an emphasis on strong communication skills in both oral and written forms
• Effective time management
• Attention to detail
• Focus on excellence
• Adaptability
• Accountability and having hard conversations

Competencies

• Microsoft Office Suites
• More than proficient in Excel
• CAMP
• Corridor

Work environment

• Typical office and computer lab environment with frequent interruptions.
• Exposure to loud noises including airplane machinery and jet engines.

Physical demands

• Ability to see and hear clearly
• Ability to read, comprehend, and speak English clearly
• Ability to climb, twist, bend, crouch, stoop, kneel, and crawl
• Ability to move in tight quarters
• Ability to sit, stand, and walk for extended periods
• Ability to work in all weather conditions as needed
• Ability to regularly push/pull up to 70 pounds
• Ability to regularly lift/move up to 50 pounds

Required education and experience

• 3-5 years aviation maintenance experience required. (Military or Commercial, Corporate preferred)
• Prior Experience with Maintenance Task Management
• Applicants must hold an FAA (Federal Aviation Administration) Airframe and Powerplant License
• Must be authorized to work lawfully in the United States, must provide two forms of Federal Identification.
• Candidates must successfully complete a comprehensive background check prior to employment. This includes verification of previous employment, education, criminal history, and any other relevant information necessary to determine the suitability for the position.
• This position is classified as a Safety-Sensitive role under Federal Aviation Administration (FAA) regulations and is subject to pre-employment and random drug and alcohol testing in accordance with FAA guidelines

EEO statement

flyExclusive does not discriminate based on race, color, religion, sex (including pregnancy, sex stereotyping, gender identity, gender expression or transgender status), national origin, sexual orientation, physical or mental disability, age, protected genetic information, status as a parent, marital status, political affiliation, or retaliation based on prior protected EEO activity.

Other duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Do you thrive in an outdoor work environment and want to be part of an exciting environmental industry? Dragonfly Pond Works is a fast-growing company offering year-round work and long-term career opportunities. Join our \"swarm\" today!

Location: Raleigh, NC 27603

Pay: $22-$26 an hour- Full-time

• Leadership: 1+ year as a crew leader, supervisor, or foreman in a related industry.
• Experience: 2+ years in lake/pond maintenance, landscaping, commercial mowing, turf management, or erosion control.
• Ability to work on slopes, near water, and in various weather conditions.
• Results-driven with strong attention to detail.
• Team-oriented and aligned with Dragonfly's values: Quality Focus, Takes Ownership, and Growth Oriented.

• Lead field operations, including repairs to ponds, lakes, and stormwater control measures (excavation, grading, dredging, erosion control, planting, etc.).
• Track labor hours and materials to stay within budget.
• Interpret and apply engineering and grading plans on-site.
• Shoot grades to ensure accurate site construction.
• Safely operate equipment such as mini-excavators, skid steers, and hydraulic dredges.
• Communicate with Regional Managers and stakeholders to clarify scope and prevent rework.
• Complete and submit thorough Project Completion Reports.
• Monitor site activities of technicians and lead by example to encourage maximum productivity and safe work practices.
• Attend and participate in safety meetings such as safe driving of company-owned vehicles trucks (with or without trailers) and other OSHA topics.

• Health, Dental, and Vision Insurance
• 401(k) matching
• Life Insurance
• Flexible Spending Accounts
• Paid Time Off
• Holiday Pay
• Employee Assistance Program
• Referral Bonus
• Protective Footwear Bonus

Dragonfly Pond Works is a leading environmental service company specializing in stormwater management. Since 2006, Dragonfly has provided routine maintenance and repairs on stormwater devices, lakes, ponds, wetlands, and underground facilities.

We are proudly an Equal Opportunity Employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.

Project Manager

6 mo. contract to perm hire

Raleigh, NC

Required Skills & Experience

• 5–10 years Project Management experience (ideal)

• Strong technical understanding, ideally with AI / ML / GenAI exposure

• Ability to understand technical details and track progress with engineers & data scientists

• Strong stakeholder communication

• Self-driven, minimal hand-holding

• Experience running multi-team, cross-functional initiatives

Experience managing multiple projects concurrently

Nice to Have Skills & Experience

• Former developer or data scientist background before PM

• Hands-on experience with AI products, AI content pipelines, embeddings

• Experience in B2B environment

Experience in multi-year, large-scale data or ML programs

Job Description

• Manage multiple AI-related projects under the hiring manager's org

• Track progress across engineering + data science teams (~10 people)

• Manage long-term initiatives (multi-year)

• Coordinate embedding strategy project with 20–30+ cross-functional contributors

• Provide weekly updates and progress tracking

• No customer-facing work — only internal stakeholders

• Move projects forward proactively, ensure clarity, keep leadership informed

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to .

To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: .

Become part of an inclusive organization with over 40,000 teammates, whose mission is to improve the health and well-being of the unique communities we serve.

Summary Echo Cardiology department seeking a Cardiac Sonographer to perform high quality studies.

Studies to include transthoracic echo, transesophageal, Definity contrast, saline bubble study, and stress echo.

Analysis and evaluation of all studies prepared by Sonographer will be a preliminary report sent to interpreting Cardiologist.

We are a heart and vascular hospital with 5 ICUs.

One being Newborn ICU so proficiency in pediatrics is a plus.
*This position qualifies for a $15,000 commitment incentive which will be paid over a three (3) year work commitment.

Learn more about the incentive program here: Hours: Friday-Sunday Responsibilities: 1.

Demonstrates competence in delivering pre-procedure and post-procedure patient care including, but not limited to patient assessment pre- and post-procedure care and, emergency cardiac care (CPR is required).

Additionally, assistance with post-procedure transport may be required.

2.

Ensures equipment is calibrated and properly maintained on a daily basis.

Performs and records all equipment maintenance and quality assurance monitoring.

Troubleshoots and identifies any equipment problems and reports to appropriate supervisor or biomedical engineering.

3.

Generates ultrasound images of the heart and/or vascular related structures.

Performs advanced cardiac ultrasound studies in care of patients with complex conditions and regularly performs multiple study types with varied anatomical areas.

4.

Performs vascular studies and real time readings/reports in the operating room for invasive and non-invasive vascular procedures.

5.

Performs studies for inpatient neonatal/NICU and pediatric patients.

6.

May perform staff training and education.

Serves as a subject matter expert and resource to Cardiovascular Sonographers.

7.

Monitors and records patient information and maintains report storage and data systems.

Compiles and enters data necessary for charge entry and prepares reports.

Also responsible for retrieval of stored information and reports from the automated storage system.

8.

Prepares procedure room and equipment for daily use and is responsible for timely and efficient room preparation between procedures.

9.

Independently responds to on-call needs for emergent procedures.

Other Information Other information: Education Requirements: ● Associate's degree in Sonography, Radiology or a related field within 3 months of hire, OR Completion of a twelve (12) month ultrasound program within 3 months of hire.

Licensure/Certification Requirements: ● Registered by the American Registry of Diagnostic Medical Sonographers (ARDMS), Cardiovascular Credentialing International (CCI), or registry eligible and become registered within one (1) year from date of hire.

Must maintain registry status and continuing education requirements annually.

RDCS or RCS- Preferred Professional Experience Requirements: ● One year minimum experience in acute hospital setting.

Knowledge/Skills/and Abilities Requirements: ● Specific competencies required by entity.

Job Details Legal Employer: NCHEALTH Entity: UNC REX Healthcare Organization Unit: Rex HeartandVascular Diagnosti Work Type: Full Time Standard Hours Per Week: 36.00 Salary Range: $38.55
- $55.43 per hour (Hiring Range) Pay offers are determined by experience and internal equity Work Assignment Type: Onsite Work Schedule: Weekend Location of Job: US:NC:Raleigh Exempt From Overtime: Exempt: No This position is employed by NC Health (Rex Healthcare, Inc., d/b/a NC Health), a private, fully-owned subsidiary of UNC Heath Care System.

This is not a State employed position.

Qualified applicants will be considered without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

UNC Health makes reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as applicants and employees with disabilities.

All interested applicants are invited to apply for career opportunities.

Please email if you need a reasonable accommodation to search and/or to apply for a career opportunity.

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At Guerbet, our mission is to equip healthcare professionals with essential contrast media, medical devices, and innovative solutions for diagnostic and interventional imaging, ultimately enhancing patient prognosis and quality of life.

With over 100 years of experience, we have established ourselves as a global leader and pioneer in medical imaging. We have advanced contrast agents such as Lipiodol® and Dotarem®, while also expanding into digital and AI-driven imaging technologies that support radiologists and clinicians around the world.

Our dedicated teams play a crucial role in improving diagnosis for cancer, cardiovascular, inflammatory, and neurodegenerative diseases.

We’re seeking a skilled Utilities & Facilities Engineer to support the reliable operation of clean utilities, plant utilities, HVAC systems, and cleanroom infrastructure in a regulated pharmaceutical manufacturing environment. This role ensures systems are designed, maintained, and operated in full compliance with GMP, safety, and regulatory expectations.

You’ll partner closely with Maintenance, Quality, EHS, Production, and vendors to support daily operations, troubleshoot issues, drive system improvements, and lead utilities/facilities projects across the site.

YOUR ROLE

Utilities & Facilities Support

• Provide technical guidance to maintenance technicians and utility operators.
• Support daily operation and maintenance of clean utilities (WFI, PW, RO, clean steam, compressed gases) and plant utilities (HVAC, boilers, chilled water, compressed air, vacuum).
• Serve as engineering SME during deviations, alarms, and operational challenges.
• Develop and approve maintenance strategies, PM optimization, and reliability improvements.
• Support lifecycle planning and spare parts strategy for utility assets.

HVAC & Cleanroom Engineering

• Act as engineering owner for cleanroom HVAC systems, including temperature, humidity, pressure cascades, and airflow control.
• Oversee HEPA certification, airflow testing, and environmental compliance.
• Support investigations and corrective actions for HVAC or environmental excursions.

Project Engineering

• Lead utilities and facilities projects (system upgrades, capacity expansions, remediation).
• Coordinate contractors, vendors, and internal teams to ensure safe, compliant execution.
• Participate in design reviews, risk assessments, commissioning, and qualification.

Quality & Compliance

• Manage deviations, change controls, and CAPAs related to utilities and facilities.
• Ensure documentation aligns with ALCOA+ data integrity principles.
• Support internal audits, regulatory inspections, and site quality reviews.
• Provide training to utility operators and maintenance staff.

Additional Responsibilities

• Serve as engineering owner for the site’s pest control program.
• Support emergency response related to utility or facility issues.
• Participate in cross-functional investigations and site-wide initiatives.
• Other duties as assigned.

YOUR BACKGROUND

Education And Experience

• Bachelor’s degree in Mechanical, Electrical, Industrial, or related Engineering field
• 8+ years of utilities/facilities engineering in pharmaceutical, biotech, or other regulated manufacturing.
• Expertise in clean utilities, HVAC systems, and GMP operations.
• Strong experience with CAPA, change control, and compliance documentation.
• Knowledge of GMP, FDA, and ISO requirements.
• Excellent analytical, organizational, and communication skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Proficiency in Microsoft Office and Quality Management Systems.

Physical & Cognitive Requirements

• Ability to walk/stand in manufacturing and mechanical areas for extended periods.
• Frequent access to utility rooms, rooftops, mechanical spaces, and cleanrooms (PPE required).
• Ability to climb ladders and lift up to 30 lbs.
• Strong analytical thinking, problem solving, and decision-making skills.
• Ability to interpret engineering drawings, P&IDs, specifications, and validation documents.
• Commitment to data integrity and high-quality documentation.

Working Conditions

• On-site role within a pharmaceutical manufacturing environment.
• Mix of office, production floor, and mechanical space work.
• May require occasional off-shift or weekend support for operations or projects.
• Occasional participation in audits or emergency response outside normal hours.

Job Title: Project Manager (Construction)

Looking for: Assistant Project Managers

Job Summary:

We are seeking a driven Project Manager to oversee the successful delivery of construction projects from pre-construction through to completion. This role is ideal for Assistant Project Managers ready to step up into a Project Manager position, taking greater responsibility for site coordination, programme delivery, and stakeholder management across construction projects.

Key Responsibilities:

• Manage construction projects from planning through to handover, ensuring delivery on time, within budget, and to required quality standards.
• Coordinate with site teams, subcontractors, consultants, and clients to ensure smooth project delivery.
• Develop and manage project programmes, budgets, and resource plans.
• Monitor site progress and proactively manage risks, issues, and variations.
• Ensure compliance with health & safety regulations, building standards, and company procedures.
• Lead project meetings and provide regular progress updates to stakeholders and senior management.
• Support procurement activities and subcontractor management.

Requirements:

• Experience working as an Assistant Project Manager, Site Manager, or Project Coordinator within construction.
• Strong understanding of construction project lifecycles and site operations.
• Good knowledge of health & safety and construction compliance requirements.
• Strong organisational, communication, and stakeholder management skills.
• Relevant qualification in Construction Management, Engineering, or a related discipline is preferred.
• Familiarity with project management methodologies or construction planning tools is beneficial.

What We’re Looking For:

• An ambitious construction professional ready to progress from supporting projects to leading them, with the ability to coordinate teams, manage site activity, and deliver high-quality projects.

Senior Project Manager Industrial / Manufacturing

A growing industrial equipment company is seeking an experienced Senior Project Manager to lead complex projects from kickoff through installation and final closeout. If you excel at coordination, communication, and keeping technical teams aligned, this role is for you.

Key Responsibilities

• Manage full project lifecycles: planning, scheduling, budgeting, and progress tracking.
• Lead meetings, document updates, and keep internal teams and customers aligned.
• Review and negotiate contracts; oversee progress billing and pay applications.
• Coordinate with engineering, manufacturing, purchasing, and installation teams.
• Serve as the primary customer contact throughout the project.
• Identify risks, maintain quality standards, and support continuous improvement.
• Assist in mentoring junior project managers as the team grows.

What You Bring

• 5+ years of project management experience in manufacturing, construction, industrial machinery, or similar environments.
• Technical aptitudemechanical, electrical, or industrial background preferred.
• Experience working with or managing field/service technicians.
• Strong communication, organization, and problem-solving skills.
• Proficiency with MS Project, Smartsheet, Asana, or similar tools.
• Ability to travel occasionally to job sites.
• Ability to meet background and drug screen requirements.

Work Environment

A combination of office and industrial settings. May occasionally work around heights, noise, or heavy equipment; PPE is provided.

EEOC Statement

We welcome applicants of all backgrounds. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Ready to Apply?

If you're a detail-driven leader who thrives in a fast-paced, technical environment, we'd love to hear from you. Apply today to be considered for this senior-level opportunity.

WHAT'S ON OFFER

• Base salary depending on experience level.
• Annual and project-based bonuses
• Company vehicle or vehicle allowance (depending on candidate preference), along with inclusive benefits package
• Very strong project pipeline and family-oriented culture – clear progression potential.

Areas of expertise include: cold storage, tilt-wall, food & beverage, and/or mission critical

The Project Manager will lead the project team and have overall responsibility for the success of assigned project(s) with a focus on budgeting, planning, scheduling, quality, and relationship with owners and subcontractors

Select Responsibilities:

• Work with project team to ensure timely completion and accuracy of project information and targets
• Organize and participate in project meetings with staff, owners, architects, and trade partners
• Prepare contracts and change orders in a timely fashion
• Prepare and communicate monthly variance cost/budget reports to the management team
• Provide oversight for all phases of construction, including safety, staffing, and ensuring contract documents are being followed and work is on schedule and within budget
• Foster strong partnership with owner to help the firm continue building on their 80% repeat business with current clients
• Produce and assist in close-out documentation

CANDIDATE QUALIFICATIONS

• Bachelor’s degree in civil engineering, construction management or other relevant discipline
• Minimum of three years’ experience in the multifamily and commercial construction industries
• Successfully managed multiple projects to completion with values ranging from $10M-$60M
• Ability to organize, analyze, and problem solve challenges when they occur on assigned projects
• Effective communication and ability to build/foster strong relationships with all internal and external stakeholders