Engineering Jobs in Raleigh Wake County Nc Flexible

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.

Job Role: Systems Engineer 5

Job Title: Systems Engineer 5 (Embedded Controls / Electronics)

Location: Clayton, NC (Onsite)

Duration: 24 Months

Travel: Up to 25% (Sanford, NC)

Interview Process: 2 rounds (Virtual/Phone, Panel)

Bill Rate Cap: up to $55-$60/hr. on C2C

Role Summary

We are seeking a senior-level Systems Engineer to support the design, development, integration, and verification of embedded electronic control systems used in clients Smart Work Tools for SSL/CTL machine applications. This role is highly hands-on and requires onsite support for lab and machine testing.

Key Responsibilities

• Support lab, bench, and on-machine verification testing of embedded software and electronics
• Provide onsite electronics and software support for development machines
• Coordinate and execute machine and system-level verification activities
• Assist with on-machine electronics testing and troubleshooting
• Develop and execute test plans and document results
• Support software feature development, configuration, and calibration integration
• Create and maintain electronic subsystem diagrams and documentation
• Identify, troubleshoot, and resolve software defects
• Support software releases, including documentation for field follow and customer updates
• Collaborate cross-functionally with engineering, product groups, and facilities teams

Required Skills & Experience

• 10+ years of experience in systems engineering, embedded controls, or electronics
• Bachelor's degree in Computer Engineering, Electrical Engineering, or related field
• Strong knowledge of embedded software development across multiple platforms
• Hands-on experience with CAN communications, specifically J1939-71
• Strong understanding of electrical system design and controls
• Advanced troubleshooting and problem-solving skills
• Ability to work independently and manage multiple priorities
• Strong written and verbal communication skills
• Experience supporting verification testing and technical documentation

Nice to Have

• Experience with heavy equipment, off-highway vehicles, or work tools
• Experience working in lab, test bench, and field environments
• Familiarity with system integration between machines and electronic work tools

Work Environment

• Onsite work at the Clayton Machine Development Center
• Combination of office work, lab testing, and field/machine testing
• Close collaboration with engineering team leaders and cross-functional partners

Our Electrical Superintendent provides overall direction on projects and develops and maintains strong working relationships with the owners and architects throughout the project lifecycle. This individual evaluates project performance, site conditions, safety and quality standards, compliance with scope, and effective management of trade partners. This individual is also responsible for ensuring that constructability reviews, logistics plans and baseline schedules achieve project turnover requirements. This is an onsite position. Must be willing to travel.

Responsibilities

• Oversee, manage, and document all day-to-day job site activities including OSHA safety compliance
• Direct field personnel according to the project plan
• Communicate issues, events, performance, and progress daily to the Project Manager
• Report any problems promptly to the Project Manager to facilitate the most cost-effective solutions
• Establish effective working relationships with Clients, BE&K team members and subcontractors
• Request advice and assistance from the General Superintendent or Project Executive on matters pertaining to materials, sequencing, scheduling, logistics, and personnel
• Perform other duties as assigned
• Project Start-Up/Turnover Meeting:Identify pre-mobilization activities in conjunction with the Project Executive, General Superintendent, and the Project Manager
• Develop start-up schedule with Project Manager and send it to the Project Executive and General Superintendent for review
• Scheduling: Assist in formulating and implementing construction schedules in the field
• Establish and implement the Project baseline schedule based on the project contracts and subcontractor input, considering any elements that might impact the schedule
• Maintain the schedule and ensure that work performed is consistent with the contract and will meet or exceed client expectations
• Update Project Schedule monthly
• Provide progress report with the six-week look ahead of schedule to the Project Manager and the field staff
• Safety:Ensure that all subcontractors participate in a safety pre-construction meeting prior to starting work on the project
• Ensure that all subcontractors have a full set of MSD sheets on the project, as well as their site-specific safety plan and current insurance certificate
• Review the project daily to ensure that all activities are being performed in accordance with all OSHA and governing requirements and the project site specific safety plan

• Quality Management:Ensure that all pertinent benchmarks for the project are established and inserted into the baseline schedule
• Ensure that all 1st delivery inspections and Benchmark inspections occur per the baseline schedule so as not to impact the progression of the subsequent work
• Ensure that the inspections are approved, documented and communicated to the project team
• Subcontractor and Site Management:Manage site pre-construction including pre-construction survey, job site utilization and staging plans
• Mobilize the field office and maintains the job site to company standards
• Organize documentation of the job site for easy access and review
• Manage subcontractor performance to quality and ethical standards
• Work with PM to identify and resolve personnel issues and construction process revisions
• Manage all phases of the construction process including documenting and reporting site activities and progress, manage excavations and assist with Job Site Utilization Plan
• Meeting Management:Attend project turnover, mobilization, and project coordination meetings
• Attend/lead safety pre-construction meetings
• Attend/lead weekly foreman and safety meetings
• Attend/lead monthly schedule review meetings
• Attend/lead Pull Plan Meetings and 6 Week Make Ready Plan Meetings
• Attend/lead subcontractor meetings
• Attend closeout meetings
• Attend owner meetings
• Administrative Management:Complete and implement construction office checklists including emergency phone lists
• Complete daily reports and maintains logs of key activities, files and shop drawings
• Manage the quality and condition of all material deliveries
• Maintain required safety reporting and all other required files to BE&K standards
• Insure that as-built working drawings are maintained as well as the current drawing log and revision log, communicating this to the subcontractors
• Project Closeout:Manage subcontractor closeout, transfer of utilities, owner training, work list and punch list

Qualifications

• Bachelor's degree in Construction Management or Engineering (not required)
• 8 to 12 years of experience related construction projects within electrical focus
• Each project has specific characteristics regarding size, complexity, sector, etc. which dictate the precise years of experience and industry knowledge necessary for success, above and beyond generic construction knowledge and experience
• Excellent team development skills and leadership abilities
• Strong ability to partner with the Project Manager and staff
• Must possess effective communication skills
• Capable of dealing with ambiguity and tight work oversight
• Must possess business judgment to negotiate the critical balance between budget and construction processes
• Excellent problem-solving skills and the ability to take action confidently and decisively
• The ability to manage and embrace change. Respond and adapt to new processes and new ways of looking at old problems
• Candidate must possess BE&K Core Values: Integrity ~ Teamwork ~ Respect ~ Discipline ~ Accountability ~ Social Responsibility

Physical Requirements:

• Ability to perform physical activities such as climbing, lifting, balancing, walking, and handling materials.
• Must be able to work in various weather conditions, including extreme heat and cold.
• Capable of standing and walking for extended periods.
• Ability to lift and carry up to 50 pounds.

Equal Employment Opportunity Statement:

BE&K Building Group is an equal opportunity employer. We are committed to creating an inclusive environment for all employees and prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship.

Date Posted:

Country:

Location:

Position Role Type:

U.S. Citizen, U.S. Person, or Immigration Status Requirements:

Security Clearance Type:

Security Clearance Status:

At Raytheon, the foundation of everything we do is rooted in our values and a higher calling – to help our nation and allies defend freedoms and deter aggression. We bring the strength of more than 100 years of experience and renowned engineering expertise to meet the needs of today’s mission and stay ahead of tomorrow’s threat. Our team solves tough, meaningful problems that create a safer, more secure world. 

The Senior Data Manager identifies all data deliverables made part of a contract and subsequently builds a data track in a Product Data Management (PDM) system. The DM identifies, with help from the Program Office, the appropriate preparers, receive the data within PDM, reviews the data for compliance, solicits and secures appropriate programmatic approval and delivers the information to the customer on time, throughout the lifecycle of the contract.

In addition, DMs are responsible for reviewing sub-tier contractor requirements, building data tracks for supplier submissions, receiving data from various suppliers, and routing for approval and/or incorporation into prime contractor deliverables to the customer as well as securing non-deliverable program work products to be configuration controlled in the PDM system and other related tasking.

This position is in McKinney Texas

What You Will Do

• Reading contracts for understanding of the deliverables
• Working in a PDM system to capture, manage, and track data deliverables and/or receivables
• Coordinating with cross-functional teams to obtain requested data
• Proofreading data for compliance to the requirement(s)
• Managing the data deliverable schedule and providing the data to the customer on-time
• Learning and understanding contractually required markings applied to data
• Running forecast reports and providing them to the appropriate stakeholders
• Providing metrics related to on-time deliveries and outstanding dispositions upon request
• Reviewing and approving sub-tier supplier statements of work for data requirements
• Supporting program meetings and providing training to program personnel and customers and/or suppliers
• Handling and protection of Company Intellectual Property (IP) as well as U.S. government IP and classified information

Qualifications you must have

• Bachelor’s degree in Science, Technology, Engineering or Mathematics (STEM) and a minimum of 2 years prior relevant experience OR a related Associate’s degree and 4 years of relevant experience OR in absence of a degree, 6 years of relevant experience
• Minimum of 2 years’ experience related to data management and/or equivalent professional experience
• Minimum of 2 years’ experience in a customer support/service role 

Qualifications We Value

• Knowledge of U.S. government defense contracts
• Knowledge of U.S. government specifications and instructions such as the Federal Acquisition Regulation (FAR) and Defense Federal Acquisition Regulation Supplement (DFARS), Data Item Descriptions (DIDs), Department of Defense (DoD) Instruction 5230.24 Distribution Statements on Technical Documents, National Industrial Security Program Operating Manual (NISPOM) (DoD 5220.22-M)
• Collaborate in a team environment
• Self-motivated and detail oriented
• Proven excellent oral and written communication and presentation skills
• Excellent proofreading skills

What We Offer

• Our values drive our actions, behaviors, and performance with a vision for a safer, more connected world. At RTX we value: Safety, Trust, Respect, Accountability, Collaboration, and Innovation.
• Relocation Eligibility

Learn More & Apply Now!

• Please consider the following role type definition as you apply for this role.
  • Onsite : Employees who are working in Onsite roles will work primarily onsite. This includes all production and maintenance employees, as they are essential to the development of our products.

As part of our commitment to maintaining a secure hiring process, candidates may be asked to attend select steps of the interview process in-person at one of our office locations, regardless of whether the role is designated as on-site, hybrid or remote.

RTX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans’ Readjustment Assistance Act.

Privacy Policy and Terms:

Click on this link to read the Policy and Terms

Date Posted:

Country:

Location:

Position Role Type:

U.S. Citizen, U.S. Person, or Immigration Status Requirements:

Security Clearance Type:

Security Clearance Status:

At Raytheon, the foundation of everything we do is rooted in our values and a higher calling – to help our nation and allies defend freedoms and deter aggression. We bring the strength of more than 100 years of experience and renowned engineering expertise to meet the needs of today’s mission and stay ahead of tomorrow’s threat. Our team solves tough, meaningful problems that create a safer, more secure world. 

The Senior Data Manager identifies all data deliverables made part of a contract and subsequently builds a data track in a Product Data Management (PDM) system. The DM identifies, with help from the Program Office, the appropriate preparers, receive the data within PDM, reviews the data for compliance, solicits and secures appropriate programmatic approval and delivers the information to the customer on time, throughout the lifecycle of the contract.

In addition, DMs are responsible for reviewing sub-tier contractor requirements, building data tracks for supplier submissions, receiving data from various suppliers, and routing for approval and/or incorporation into prime contractor deliverables to the customer as well as securing non-deliverable program work products to be configuration controlled in the PDM system and other related tasking.

This position is in McKinney Texas

What You Will Do

• Reading contracts for understanding of the deliverables
• Working in a PDM system to capture, manage, and track data deliverables and/or receivables
• Coordinating with cross-functional teams to obtain requested data
• Proofreading data for compliance to the requirement(s)
• Managing the data deliverable schedule and providing the data to the customer on-time
• Learning and understanding contractually required markings applied to data
• Running forecast reports and providing them to the appropriate stakeholders
• Providing metrics related to on-time deliveries and outstanding dispositions upon request
• Reviewing and approving sub-tier supplier statements of work for data requirements
• Supporting program meetings and providing training to program personnel and customers and/or suppliers
• Handling and protection of Company Intellectual Property (IP) as well as U.S. government IP and classified information

Qualifications you must have

• Bachelor’s degree in Science, Technology, Engineering or Mathematics (STEM) and a minimum of 2 years prior relevant experience OR a related Associate’s degree and 4 years of relevant experience OR in absence of a degree, 6 years of relevant experience
• Minimum of 2 years’ experience related to data management and/or equivalent professional experience
• Minimum of 2 years’ experience in a customer support/service role 

Qualifications We Value

• Knowledge of U.S. government defense contracts
• Knowledge of U.S. government specifications and instructions such as the Federal Acquisition Regulation (FAR) and Defense Federal Acquisition Regulation Supplement (DFARS), Data Item Descriptions (DIDs), Department of Defense (DoD) Instruction 5230.24 Distribution Statements on Technical Documents, National Industrial Security Program Operating Manual (NISPOM) (DoD 5220.22-M)
• Collaborate in a team environment
• Self-motivated and detail oriented
• Proven excellent oral and written communication and presentation skills
• Excellent proofreading skills

What We Offer

• Our values drive our actions, behaviors, and performance with a vision for a safer, more connected world. At RTX we value: Safety, Trust, Respect, Accountability, Collaboration, and Innovation.
• Relocation Eligibility

Learn More & Apply Now!

• Please consider the following role type definition as you apply for this role.
  • Onsite : Employees who are working in Onsite roles will work primarily onsite. This includes all production and maintenance employees, as they are essential to the development of our products.

As part of our commitment to maintaining a secure hiring process, candidates may be asked to attend select steps of the interview process in-person at one of our office locations, regardless of whether the role is designated as on-site, hybrid or remote.

RTX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans’ Readjustment Assistance Act.

Privacy Policy and Terms:

Click on this link to read the Policy and Terms