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Fda Project Jobs (NOW HIRING)

Steuben Foods Inc

Senior Project Engineer

Elma, NY · On-site

$100K/yr

MBA a plus. * 7+ years of engineering experience within an FDA-regulated facility such as food and ... Capital project engineering experience leading $3-$10M projects, with demonstrated success in ...

Qualdoc

Mid-Level Project Engineer

Richmond, VA · On-site

$105K/yr

Mid-Level Project Engineer Location: Richmond, Virginia Job Type: Direct Hire | Full-Time Starting ... Ensure all activities comply with FDA cGMP and company policies * Support change control processes ...

Samprasoft

Technical Project Manager

Rancho Cordova, CA · Hybrid

The ideal candidate will bring deep experience in managing IT endpoint systems, compliance standards (e.g., HIPAA, HITECH, FDA), and have a proven track record of leading projects in regulated health ...

Qualdoc

Mid-Level Project Engineer

Richmond, VA

$105K/yr

Mid-Level Project Engineer Location: Richmond, Virginia Job Type: Direct Hire | Full-Time Starting ... Ensure all activities comply with FDA cGMP and company policies * Support change control processes ...

Albertsons

Process Engineer - Dairy

Boise, ID · On-site

Familiarity with dairy regulatory and quality frameworks, including FDA/PMO requirements, HACCP, and internal quality standards * Demonstrated experience optimizing production lines in a regulated or ...

Kaav Inc.

Technical Project Manager

Rancho Cordova, CA · Hybrid

The ideal candidate will bring deep experience in managing IT endpoint systems, compliance standards (e.g., HIPAA, HITECH, FDA), and have a proven track record of leading projects in regulated health ...

Globusmedical

PROJECT ENGINEER

Audubon, PA · On-site

Creating and maintaining project plans and FDA complaint Design history Files (DHF) for each project * Managing all aspects of assigned projects to ensure timely completion of tasks while remaining ...

Stereotaxis

Project Manager

Minneapolis, MN · On-site

... FDA, ISO 13485, and other relevant medical device industry regulations and standards. • Identify potential project risks and develop mitigation strategies. Conduct regular risk assessments and ...

Globus Medical

PROJECT ENGINEER

Audubon, PA · On-site

Creating and maintaining project plans and FDA complaint Design history Files (DHF) for each project * Managing all aspects of assigned projects to ensure timely completion of tasks while remaining ...

Cognito Therapeutics

Sr. Project Manager

Cambridge, MA · On-site

Sr. Project Manager, Cognito Therapeutics, Inc. Location: Boston, or Remote USA, Full-time Company ... We were awarded a Breakthrough designation by the FDA in December 2020 based upon our feasibility ...

Cognito Therapeutics

Sr. Project Manager

Cambridge, MA · On-site +1

Sr. Project Manager, Cognito Therapeutics, Inc. Location: Boston, or Remote USA, Full-time Company ... We were awarded a Breakthrough designation by the FDA in December 2020 based upon our feasibility ...

New

Medinext Global LLC

Project Leader

Skaneateles Falls, NY · On-site

$90 - $95/hr

Position Title - Project Leader Job Location - Skaneateles Falls, NY, USA Bill Rate Range - $90 to $95 Estimated Duration (In Months) - 8 Work Model - Onsite Must have Skills/Attributes - Clinical ...

Globus Medical

Project Engineer

Audubon, PA · On-site

Creates and maintains project plans and FDA complaint Design history Files (DHF) for each project * Manages all aspects of assigned projects to ensure timely completion of tasks while remaining in ...

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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.

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Fda Project jobs near you
Infographic showing various Fda Project job openings in the United States as of May 2026, with employment types broken down into 94% Full Time, 1% Part Time, and 5% Contract. Highlights an 100% Physical job distribution.
Senior Project Engineer

Senior Project Engineer

Steuben Foods Inc

Elma, NY • On-site

$100K/yr

Full-time

Posted 21 days ago

Steuben Foods rating

5.3

Company rating: 5.3 out of 10

Based on 5 frontline employees who took The Breakroom Quiz

332nd of 379 rated food and drinks producers

Job description

This is an exciting technical engineering leadership opportunity within the US's largest low acid aseptic beverage co-manufacturing operation. This position will lead engineering functions, technical excellence, and capital projects within a state-of-the-art manufacturing operation serving leading global food & beverage companies, producing products including almond milk, smoothies, RTD protein shakes, and coffee creamers. Responsibilities will include:
  • Leading complex, strategic cross-functional engineering projects for new product launches, process scale-up, and packaging systems optimization within a low acid aseptic beverage manufacturing operation.
  • Applying process engineering expertise in low acid aseptic beverage manufacturing, including thermal processing, CIP, ESL, and filling technologies for TetraPak, Combi, Bottling, and Pouch lines.
  • Overseeing $3-$10M capital projects including new construction, equipment upgrades, equipment installations, and full manufacturing line installations for beverage manufacturing processes, thermal processing, CIP, ESL, TetraPak, Combi, Bottling, and Pouch filling lines.
  • Managing capital project planning and execution, ensuring on-time and on-budget delivery of high-impact initiatives supporting business growth.
  • Leading and designing project budgets, schedules, construction, commissioning, and project takeover activities.
  • Overseeing capital projects for packaging systems including robotics and automation systems for palletizers.
  • Leading and managing engineers, contractors, and external vendors.
  • Partnering with Manufacturing, Maintenance, Quality, and R&D to implement best-in-class engineering solutions aligned with cGMP, HACCP, FDA, and OSHA standards.
  • Providing cGMP documentation, writing SOPs, and developing PFDs and P&IDs, equipment and piping layouts, and process and equipment specifications for bids.
  • Managing budgets, forecasts, and long-term engineering master plans while ensuring compliance with food safety and regulatory requirements.
  • Developing, mentoring, and coaching engineering talent to build a world-class technical organization.

Desired Skills & Experience
  • BS or MS in Mechanical Engineering, Electrical Engineering, Chemical Engineering, or a related engineering field. MBA a plus.
  • 7+ years of engineering experience within an FDA-regulated facility such as food and beverage, dairy, nutritional products, infant formula, or pharmaceutical manufacturing.
  • Process engineering experience in low acid aseptic beverage manufacturing, including products such as smoothies, protein drinks, and almond milk, is strongly preferred.
  • Capital project engineering experience leading $3-$10M projects, with demonstrated success in facility, utility, processing, filling, and packaging line installations including TetraPak, Combi, Bottling, and Pouch lines.
  • Demonstrated expertise in aseptic processing, thermal processing, and packaging technologies including TetraPak, Combi, and ESL systems.
  • Food safety experience working within FDA, GMP, and HACCP compliance frameworks.

Salary Range: $100,000
Steuben Foods is committed to equal employment opportunity. We recruit, employ, train, compensate, and promote without regard to race, religion, color, national origin, age, sex, disability, protected veteran status, or any other basis protected by applicable federal, state, or local law.

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