Engineering Structures Scimago Jobs in Garner, NC

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.

Reporting to the VP of Estimating, the Schedule Development Manager oversees the development of detailed project schedules for all Faulconer Construction areas. The Schedule Development Manager will provide high-quality project schedules that exceed industry standards. This position will be responsible for guiding scheduling construction sequencing, developing, and delivering training, and supervising critical path analysis. The Schedule Development Manager will coordinate between Operations, Field Leadership, the Shop, and others to support the scheduling needs. The Schedule Development Manager will always maintain Faulconer Core Values.

Primary Job Responsibilities:

• Lead the development of detailed project schedules along with the project teams’ input for all work in progress
• Collect progress information for updating and reporting project status
• Performing impact analysis for potential delays and changes
• Utilizing schedule baselining to maintain “as-built” project schedules
• Develop bid proposal schedules
• Ensure scheduling consistency between all Faulconer area offices
• Oversee and provide training to enhance company scheduling capabilities in P6- desktop and mobile, as well as 4-week look ahead schedules
• Participate in the following Project Meetings: Preconstruction Handoff, Kickoff, Exit Strategy, Post Project Review, and Bi-Weekly PM Meetings
• Work to improve project revenue forecasting through P6
• Learn and implement relevant lean construction principles
• Participate in the reporting of Company Equipment Backlog via P6

Travel Expectations: Up to 25% of time outside the home office, traveling to other area offices and project locations.

Qualifications:

• 3+ years of direct work experience in a construction management capacity, including all aspects of project execution.
• Experience with P6 (or equivalent scheduling software) and Microsoft Office Suite.
• Experience in working both independently and in a team-oriented, collaborative environment.
• Excellent verbal, written, and interpersonal communication skills.
• Can conform to shifting priorities, demands, and timelines through analytical and problem-solving capabilities.
• Ability to elicit cooperation from a wide variety of sources, including upper management, other departments, and vendors.
• Must be able to learn, understand, and apply new technologies.
• Ability to effectively prioritize and execute tasks in a high-pressure environment.
• Competent and proficient with the full Microsoft Office Suite.
• Bachelor's or Master’s degree in engineering, construction management, business, technology, or related field of study.

Work Authorization / Security Clearance

• Employee must be eligible to work in the United States.
• Drug screens are required after an offer is accepted and continued employment is based on initial drug screen and any future/random drug screens administered.
• A background check will be required.
• A confidentiality agreement may be required.
• Driving records may be required.
• Further clearance may be required by clients (i.e. government or military site access).

Faulconer Team Attributes:

• Positive, team oriented attitude
• Open to personal and professional training and development

EOE:

It is the policy of Faulconer Construction Company, Inc. to assure that applicants and employees are treated without regard to their race, religion, sex, color, national origin, age, or disability. Such actions shall include employment, upgrading, promotion, or transfer; recruitment or recruitment advertising; layoff or termination; rates of pay or other forms of compensation; and selection for training, including apprenticeship and on-the-job training. Comments or complaints regarding matters described in the preceding paragraph should be directed to Human Resources. Correspondence directed to HR should be sent to 2496 Old Ivy Road, Charlottesville, VA 22903.

Overview/Responsibilities

As a Project Manager based out of our Raleigh office, you will act as an Owner’s Representative to oversee the design and construction of a variety of project types including light manufacturing, lab/office and multi-family residential. The projects will be in various stages, including entitlements, design and construction, all ranging in various complexities with total project costs of $10 Million to $500+ Million.

The successful candidate will demonstrate ability to lead multi-disciplinary teams; be responsible for leading the successful design and construction performance, development and management of the project budget and the project schedule while mitigating risk to implementing strategic and tactical schedule and budget initiatives; ensure compliance to quality and regulatory requirements; direct all consultants, including but not limited to architects, engineers, furniture, major equipment, and IT from design through construction to move-in. The Project Manager will be required to communicate and collaborate with client executive leadership and designated client staff in the decision-making processes regarding entitlements, design and construction as well as mentor all team members and staff to foster a highly collaborative and high performing team environment.

Qualifications and Skills

• 5+ years minimum similar experience
• Bachelor’s degree in building construction, engineering, architecture, facilities management or similar
• Exceptional technical and project management skills
• Ability to ensure that all project objectives are achieved
• Capability to manage competing demands on multiple client projects simultaneously
• Ability to prioritize and handle challenges on an independent basis

Compensation

The salary range for this position is $125,000 - $145,000. Actual compensation within the range will be dependent upon the individual's skills, experience, qualifications and location, and applicable employment laws. In addition to base pay, you may be eligible to participate in our performance-based incentive compensation bonus plan.

Redgate provides competitive compensation and an attractive benefits package that includes a performance bonus based on individual and organizational success, health care coverage, dental, vision, and a 401(k) plan with an employer matching contribution policy.

Redgate is an inclusive, Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, marital status, national origin, political affiliation, disability, genetic information, age, membership in an employee organization, parental status (including pregnancy), military service, any other legally protected class, or other non-merit factors.

Project Manager (Mechanical Construction) at BMWC Constructors

Driven by Vision|Powered by Passion

Location: Raleigh, NC

Company Overview: Working for global leaders in the aerospace, chemical, steel, pharmaceutical, oil & gas, power generation, and semiconductor industries, BMWC builds facilities that deliver critical products to consumers across the globe. BMWC is a dynamic and forward-thinking construction company. We pride ourselves on being among the most progressive and innovative companies in our field. Our work is fast-paced, diverse and involves projects within rapidly evolving industries. BMWC executes some of the most complex and critical projects in the construction industry. We are passionate about what we do, and we’re looking for a skilled Project Manager to join our team. If you share our passion for executing large, complex, and fast-paced construction projects for customers within rapidly expanding industries, BMWC has an opportunity for you.

Position Summary: As a Project Manager, you’ll play a crucial role in leading and executing construction projects. You will be responsible for managing the development and execution of complex mechanical construction projects ranging from $5M to $30M in direct-hire construction. Leading a team of experienced professionals, you will be responsible for delivering safe projects on time and within budget. If you thrive in a challenging environment and are ready to contribute to our success, we want to hear from you!

Responsibilities:

Project Planning and Execution:

• Develop and manage project plans, set milestones, and allocate resources effectively.
• BMWC is a self-perform contractor; you will work directly with craft supervision throughout the project lifecycle.
• Monitor project progress, identify risks, and implement corrective actions.
• Execute company safety standards, incentives, and compliance programs.
• Strategic contract management, including commercial terms and craft labor agreements.

Budget and Cost Management:

• Prepare, manage, and forecast project costs, budget, and overall profitability.
• Monitor and analyze expenses and costs, including labor, material, and equipment.
• Prepare project status reports for BMWC’s leadership team and clients.

Stakeholder Communication:

• Provide updates for all project phases with necessary stakeholders, including due dates, impacts, and adjustments during the life of the project.
• Liaison and collaborate with clients, subcontractors, and internal teams, proactively following up on requests or issues as needed.

Client Management:

• Participate in activities/events that promote strong client relationship building.
• Work with the Marketing and Sales Department to pursue new client opportunities, develop proposals, and win new work.

Team Leadership:

• Lead project teams, motivate team members, and foster a positive work environment.
• Mentor younger employees and prepare them for the next steps in their careers, aligning with BMWC’s core value of “People”.
• Resolve conflicts and facilitate effective communication.

Qualifications and Experience

• Bachelor’s degree in Construction Management, Engineering, or related field.
• Minimum of 8 years of experience managing industrial construction project teams.
• Proficiency in project management software (e.g., Primavera, Procore, Microsoft Project).
• Strong leadership, communication, and problem-solving skills.
• Demonstrated proficiency in leading and managing cross-functional team members responsible for project controls, estimation, purchasing, safety, quality, and virtual design.

Benefits: We offer one of the best and most comprehensive benefits packages in the industry, as our commitment to employee well-being is critical to our company’s success. Our benefits include day 1 medical coverage and 100% 401K vesting with company match, annual bonuses and profit sharing, and MUCH MORE!

As one of the premier specialty construction companies in the country, our employees enjoy a focus on growth and development, work/life balance, and one of the best safety records in the industry. We are 100% management-owned, making our employees' development and advancement paramount to our success.

Join BMWC Constructors and be part of a team that’s shaping the future of construction!

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