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Fda Project Jobs in Crete, IL (NOW HIRING)

CAI

Data Center Commissioning Project Manager

Chicago, IL · On-site

$128K - $150K/yr

We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries. Are ...

Ferrara

Sr. Specialist, Regulatory

Chicago, IL · On-site

$80K - $112K/yr

Advanced knowledge of 21 CFR FDA food and DSHEA regulations and high level of comfort with regulatory interpretation. * Strong knowledge of Kosher, Non-GMO project Verified, Gluten-Free Certified ...

Tempus

Senior Scientist R&D

Chicago, IL · On-site

$94K - $135K/yr

Strong understanding of FDA, EUA, and other global regulatory requirements * Demonstrated technical and project leadership expertise * Good organization skills, detailed oriented mindset * Ability to ...

Tempus

Senior Scientist R&D

Chicago, IL · On-site

$94K - $135K/yr

Strong understanding of FDA, EUA, and other global regulatory requirements * Demonstrated technical and project leadership expertise * Good organization skills, detailed oriented mindset * Ability to ...

W3Global Inc.

Meat Scientist

Chicago, IL · On-site

$75K - $85K/yr

Knowledge of USDA and FDA regulations applicable to meat product manufacturing. * Proficiency with Microsoft Office applications. * Ability to independently manage multiple projects while maintaining ...

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Fda Project information

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 the key skills and qualifications needed to thrive as an FDA project manager?

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 cities near Crete, IL are hiring for Fda Project jobs?

Cities near Crete, IL with the most Fda Project job openings:

Fda Project jobs near you

Data Center Commissioning Project Manager

CAI

Chicago, IL • On-site

$128K - $150K/yr

Full-time

Medical, Life, PTO

Re-posted 20 days ago

Job description

*THIS IS NOT A DATA ENGINEERING RELATED POSITION*
 
Position Description:
Your responsibilities as a Data Center Cx PM will include:
Working with project teams at client sites to inspect, test, and troubleshoot data center/ building commissioning facilities and/ or equipment. This person is responsible for identifying and coordinating activities for commissioning and reporting. The Project Manager will be the POC with client (data center/ building commissioning companies) personnel and the Regional Manager. The Project Manager will execute the work as well as oversee it. Electrical and/or Mechanical commissioning experience is required.
 
Requirements include:
Position Requirements:
BS in an electrical, mechanical, engineering field or equivalent experience
5-10+ years or more of experience in commissioning and qualification in the Data Center industry, Leading large (minimum of 4 megawatts) projects/facilities. Comfort in the Construction industry (managing vendors, clients, subcontractors) is a plus.
Experience with commissioning plans/test scripts, schedules, budgets, change orders and summary reports is desired.
Experience managing multi-disciplinary teams with full commissioning responsibility is desired.
 
Other Requirements:
Excellent oral and written communication skills in English
Able to travel domestically and internationally as required 
Able to work (paid) overtime 
Able to work in the US without sponsorship now or any time in the future. 
 
About CAI
CAI is established in 1996, that has grown year over year to more than 800 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
 
Are You Ready?
Our approach is simple; we put the client's interests first, we do not stop until it is right, and we will do whatever it takes to get there.
We are committed to living our Foundational Principles, both professionally and personally:
We act with integrity
We serve each other
We serve society
We work for our future
 
Benefits
Our full-time positions offer competitive compensation and benefits which include: 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.
 
CAI Operations DCx Managers will be exposed to cutting edge technologies in the Hyperscale and other spaces. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing data technologies to market. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
#LI-MV1 #MISSIONCRITICAL
$128,300 - $150,800 a year
Average salary range, not including benefits or compensatory time and possible discretionary bonuses.
 
CAI Benefits:
Comprehensive Health Insurance coverage
24 days of Paid Time Off
Company paid Life Insurance
Company paid Long Term Disability
We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all - our employees, our customers, and the broader society.
 
This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO). 
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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