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Fda Project Jobs in Virginia (NOW HIRING)

Intellectt INC

Project Engineer

Richmond, VA · On-site

Project Engineer Location: Richmond, VA. Duration: Longterm Job Summary: Project Engineer role ... The role requires strong experience in pharma or FDA-regulated environments with GMP knowledge and ...

Kelly Services

Project Engineer II

Henrico, VA · On-site

The Project Engineer II is responsible for managing small to large-scale packaging engineering projects within a cGMP and FDA-regulated manufacturing environment. This role focuses on packaging ...

FAREVA

Project Engineer II

Henrico, VA

Ensure all projects comply with FDA, cGMP, EPA, safety, and internal standards. * Promote workplace safety and ensure safety requirements are integrated into all project scopes. * Resolve process and ...

Instant Systems Inc

Project Manager

Norfolk, VA

Ensure compliance with medical device regulations (e.g., FDA, ISO 13485, ISO 9001) throughout the project lifecycle Monitor and track project performance, proactively identifying risks and ...

Instant Systems Inc

Project Manager

Norfolk, VA

Ensure compliance with medical device regulations (e.g., FDA, ISO 13485, ISO 9001) throughout the project lifecycle. * Monitor and track project performance, proactively identifying risks and ...

Omnicom Health

Project Manager

Williamsburg, VA · On-site

Project Manager JOB SUMMARY : The Project Manager provides project management leadership across ... The promotional requirements for pharmaceuticals under the FDA and FTC and other applicable federal ...

Snow Companies

Project Manager

Williamsburg, VA · On-site

Project Manager JOB SUMMARY : The Project Manager provides project management leadership across ... The promotional requirements for pharmaceuticals under the FDA and FTC and other applicable federal ...

Snow Companies

Project Manager

Williamsburg, VA · On-site

Project Manager JOB SUMMARY : The Project Manager provides project management leadership across ... The promotional requirements for pharmaceuticals under the FDA and FTC and other applicable federal ...

Omnicom Health

Project Manager

Williamsburg, VA · On-site

Project Manager JOB SUMMARY : The Project Manager provides project management leadership across ... The promotional requirements for pharmaceuticals under the FDA and FTC and other applicable federal ...

Instant Systems Inc

Project Manager

Norfolk, VA · On-site

Ensure compliance with medical device regulations (e.g., FDA, ISO 13485, ISO 9001) throughout the project lifecycle. * Monitor and track project performance, proactively identifying risks and ...

Consertus, Inc.

Project Manager (GV)

Goochland, VA · On-site

Ensure all work complies with FDA, GMP, OSHA, and site-specific safety and documentation standards. Prepare and maintain project documentation: URS, design packages, commissioning plans, status ...

Consertus, Inc.

Project Manager (GV)

Goochland, VA · On-site

... with FDA, GMP, OSHA, and site-specific safety and documentation standards. • Prepare and maintain project documentation: URS, design packages, commissioning plans, status reports, and closeout ...

Lilly

Project Manager - Utilities - GFD

Richmond, VA

$500/wk

... FDA, ISPE Baseline Guides, ASME BPE, USP, NFPA, local AHJ). * Safety/Environment: Develop and maintain safety and environmental execution plans for projects. Ensure compliance with safety and ...

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Fda Project information

What are the key skills and qualifications needed to thrive as an FDA Project Manager, and why are they important?

To thrive as an FDA Project Manager, you need a strong background in regulatory affairs, project management, and a degree in life sciences or a related field. Familiarity with FDA submission requirements, electronic common technical document (eCTD) systems, and project management tools like MS Project or Asana is essential. Excellent communication, organization, and problem-solving abilities help manage cross-functional teams and ensure compliance. These skills ensure that projects meet regulatory standards, progress efficiently, and achieve timely FDA approvals.

What are some common challenges faced by professionals working on FDA project teams?

Professionals working on FDA project teams often encounter challenges related to regulatory compliance and shifting guidelines. Navigating complex documentation requirements, coordinating with cross-functional teams (such as clinical, regulatory, and quality assurance), and meeting strict submission deadlines are all common hurdles. Effective communication and adaptability are essential, as projects frequently involve collaboration across departments and ongoing updates based on regulatory feedback. Successfully managing these challenges helps ensure product approval and supports career advancement within regulatory affairs.

What is an FDA Project?

An FDA Project typically refers to a project that involves compliance with the U.S. Food and Drug Administration (FDA) regulations. These projects can include developing, testing, or bringing to market medical products such as drugs, medical devices, biologics, or food items. The goal of an FDA Project is to ensure that products meet safety, efficacy, and quality standards set by the FDA before they are approved for public use. Such projects often require extensive documentation, clinical trials, and regulatory submissions to obtain FDA approval.

What is the difference between Fda Project vs Fda Reviewer?

AspectFda ProjectFda Reviewer
Required CredentialsTypically requires a background in life sciences, engineering, or related fields; often includes project management certificationsRequires a degree in life sciences, pharmacy, or medicine; often needs FDA-specific training or experience
Work EnvironmentProject teams within pharmaceutical or biotech companies, regulatory agencies, or consulting firmsRegulatory agencies, pharmaceutical companies, or biotech firms reviewing submissions
Employer & Industry UsageUsed in project management contexts to oversee regulatory submissions and complianceUsed in regulatory review processes to evaluate drug, device, or food applications

In summary, Fda Project roles focus on managing regulatory initiatives and ensuring compliance within organizations, while Fda Reviewers are responsible for evaluating and approving submissions directly for regulatory approval.

What are popular job titles related to Fda Project jobs in Virginia? For Fda Project jobs in Virginia, the most frequently searched job titles are:
What job categories do people searching Fda Project jobs in Virginia look for? The top searched job categories for Fda Project jobs in Virginia are:
What cities in Virginia are hiring for Fda Project jobs? Cities in Virginia with the most Fda Project job openings:
Fda Project jobs near you
Project Engineer

Project Engineer

Intellectt INC

Richmond, VA • On-site

Contractor

Posted 8 days ago

Job description

Job Role: Project Engineer
Location: Richmond, VA.
Duration: Longterm
Job Summary:

Project Engineer role supporting a large API greenfield facility build in Virginia. The position will support one or more project nodes such as HVAC, utilities, distribution systems, logistics/warehouse, electrical, mechanical, or process piping. The role requires strong experience in pharma or FDA-regulated environments with GMP knowledge and full-time on-site availability preferred.

Key Responsibilities:

  • Support execution of assigned project node(s) within a large CAPEX build
  • Coordinate with engineering, construction, and CQV teams
  • Ensure design, installation, and operational readiness are aligned
  • Track project progress, identify risks, and help resolve issues
  • Coordinate system dependencies across different disciplines
  • Support system turnover, commissioning readiness, and handoff activities
  • Ensure compliance with GMP and FDA-regulated standards
  • Communicate with stakeholders to keep deliverables on schedule

Required Skills:

  • Pharma industry or FDA-regulated environment experience
  • GMP experience
  • Experience in at least one of the following areas:
    • HVAC
    • Utilities / clean utilities / dirty utilities
    • Distribution systems
    • Logistics and warehouse
    • Electrical systems
    • Mechanical systems
    • Process piping
  • Strong cross-functional coordination skills

Preferred Skills:

  • CAPEX project experience
  • Greenfield/site build experience
  • CQV, commissioning, or system turnover experience

For more information, please reach out at 732-719-4936 or share your updated resume with padma.priya@intellectt.com.