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Fda Project Jobs in Crete, IL (NOW HIRING)

Senior Project Engineer

Chicago, IL · On-site

$102K - $132K/yr

Senior Project Engineer Location: Illinois Duration: Long-Term Job Overview The Senior Project ... Working knowledge of FDA cGMP, OSHA, environmental, building, and fire code requirements. * Strong ...

Effectively communicate project-related information including the planning and execution of ... Thorough knowledge of ICH-GCP, Food and Drug Administration (FDA), and European regulations

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 ...

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 ...

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 ...

New

Experience5+ years? experience working on capital expenditure projects as project manager,Food Industry requiredDairy process preferredMinimum of 3 years of USDA or FDA regulated plant experience ...

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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:

Consultant, Project Engineer - CAPEX - Manufacturing

Integrated Project Management

Chicago, IL

Full-time

Medical, Retirement

Posted 23 days ago


Job description

For more than three decades, premier organizations have trusted IPM to help ensure the successful execution of their strategic portfolios and critically important initiatives. With 90 percent repeat business and a Net Promoter Score in the world-class category, IPM has a reputation that is second to none.

Headquartered in Chicago with offices in Boston, Parsippany, Minneapolis, St. Louis, Los Angeles and San Francisco, IPM has led more than 5,000 projects for over 500 clients in the United States and across continents. Our clientele ranges from Fortune 100 companies to startups.

Our Consultants are our full-time employees. They are our most important asset and the competitive advantage that sets us apart from the rest.

We are seeking a Project Engineer with CAPEX experience in manufacturing including experience in capacity or technology improvements (vertical start-up, operational readiness, consolidation, relocation. The Project Engineer will support client transformations where capital investment, operational excellence, and business transformation intersect. This role is ideal for someone who can lead capital projects while embedding OpEx principles, including improving safety, quality, cost, and delivery.

JOB DESCRIPTION

In this role your focus will be:

  • Ensuring successful delivery outcomes and value realization across end-to-end or phase-driven projects, from initiation and scoping through scale-up and commissioning
  • Management of projects within established scope, schedule, andbudget while meeting and exceeding IPM project management standards
  • Acting as a trusted advisor to client leaders regarding delivery, translating business strategy into executable capital roadmaps, facilitating steering committees, core teams, and managing vendor relationships, and diagnosing capital and project management pain points and designing practical, scalable solutions
  • Leading or supporting end-to-end capital project lifecycle activities including opportunity identification and business case justification, Front-End Planning (FEL), scope definition, and design readiness, and realization across execution, commissioning, and startup
  • Embedding Lean, OpEx, and Continuous Improvement principles into capital planning and execution while aligning capital projects to manufacturing excellence
  • Leading capital initiatives in GMPregulated environments and partner with Quality, Validation, and Regulatory teams to ensure compliant, rightfirsttime delivery
  • Integrating capital projects into site OpEx and quality maturity models
  • Supporting growth, automation, sustainability, and productivity investments and ensure capital solutions support plant throughput, labor efficiency, and operational stability while minimizing downtime and disruption to ongoing operations
  • Proactively identifying execution risks and leading mitigation planning
  • Driving capability building throughcoaching client project managers, engineers, and operators, developing capital playbooks, standards, templates, and OpExaligned delivery frameworks, and supporting organizational readiness for new assets, systems, and processes
  • Creating and presenting both executive-level and detailed updates throughout an engagement and within a final project readout deck

DESIRED SKILLS AND EXPERIENCE

The successful candidate for this position should have the following skills and experience:

  • A bachelor's degree with a preference in Engineering, Construction Management, Operations Management, Project Management or similar (e.g., Industrial Engineering, Supply Chain Management)
  • At least 6 years of professional experience delivering successful capital projects within consulting or matrixed enterprise environments includingcapacity or technology improvements (vertical start-up, operational readiness, consolidation, relocation)
  • Have a strong foundation in capital project management best practices and be well versed in operational excellence methodologies
  • Demonstrated experience across Life Sciences, Consumer, and/or Industrial sectors
  • Experience working directly with senior stakeholders, acting as the owner's representative and trusted advisor
  • Be dedicated to delivering high-quality outcomes focused on scope, budget, and schedule (Project Management Professional, Lean Manufacturing, Six Sigma, Professional Engineer, and APICS certifications are a plus)
  • Have familiarity with GMP, FDA, OSHA, ISO, and environmental requirements
  • Willingness to travel based on client needs

If you think you can work with high-caliber colleagues on complex and high-profile projects, we'd like to hear from you. In return, we'll provide you with the opportunities, support, and training to develop your career to the fullest of your capabilities; it's not just what you've done that's interesting to us - it's what you are capable of achieving.

WhyIPM

  • Diverse projects: we take on a wide variety of project work, ensuring significant exposure to a variety of clients and a broad range of opportunities to grow your professionalexperience
  • Collaborative work environment: we have a well-structured system to bring support from managers, internal teams, and our Centers of Excellence (CoE),which serve as resources and SME's for specificservices and industry knowledge, tools, and best practices
  • Family with engaging culture: we believe in protecting our greatest asset, our people, with a culture that nurtures a caring environment with a transparent communication approach, culture-building andteam-buildingevents, both regional and companywide
  • Professional development: we're committed to your training and development. You'll get a thorough onboarding to ensure you're prepared while creating the bandwidth you need to further your career at IPM. You are IPM's future; we only promote from within
  • High visibility and direct client impact: you'll have the opportunity to shape how your clients achieve their network strategies through well planned and executed capital projects.
  • Comprehensive compensation and benefits program: including 100% employer-paid health, 401(k) matching, business development incentives, and performance bonus amongst many other elements. Salary Range: $120,000 - $150,000
  • Passion for the greater good: we are steadfast in our devotion to the communities we serve and in actively promoting employee involvement in community improvement projects. We've createdProject Mercyto channel and maximize our philanthropic efforts every quarter.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

Disclaimer: Where a specific pay range is noted, it is a good faith estimate at the time of this posting. The actual salary offered will be based on experience, skills, qualifications, and market/business considerations.

IPM is an equal opportunity employer. We are committed to providing equal employment opportunities to all employees and applicants for employment.

IPM's hybrid work environment requires a minimum of three days in the office. The specific days are flexible and may vary depending on project schedules and meetings. On-site locations may also vary. In addition, we follow our clients' guidance on on-site requirements, so the minimum number of days in the office may increase depending on the client and project assignment.