PREREQUISITES BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience, Sterile Injectable experience preferred. Responsibilities will include, but are not limited to, the following: 1. Participate in the development of the CMC regulatory strategy for post-approval small molecule product submissions, including global supplements/variations and responses to health authority queries. 2. Prep

SAP Plant Maintenance (SAP PM) 12 months Remote with travel to onsite (Chicago IL) Must have food & beverage manufacturing or consumer packaged goods industry experience Solid/Strong comm skills compliance with food industry standards (e.g., FDA, GMP, HACCP) Regards Stephen DJA stephen at itresonance dot com

Solution Architecture and Design: Lead the design and development of LabVantage LIMS solutions tailored to business and laboratory needs. Develop system workflows, configurations, and integrations with other enterprise systems (e.g., S4 Hana ERP, MES, ELN, SDMS). Define data models, interface designs, and system configurations. Implementation and Deployment: Oversee installation, configuration, and validation of LabVantage LIMS applications. Develop and execute project plans, ensuring timely an

Job Description: Must-Haves: 1. Configuration Management Expertise: Proven understanding and application of configuration management principles and best practices within a complex product development environment. 2. Medical Device Experience: Experience working within the medical device industry or other regulated sectors with knowledge of FDA regulations and ISO standards. 3. Jama Connect Proficiency: Hands-on experience using Jama Connect tool to manage requirements management and traceability

Description: *Remote role* Our F500 Pharma Client is seeking a consultant with strong technical XRPD expertise in solid oral dosage tablet for NDA readiness. We can facilitate w2 and corp-to-corp consultants. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance. Rate: $190 - $200 / hr. w2 Experience Requirements: Pharmaceutical Drug Development Experience Solid Oral Dosage Experience Str

Job Description: *Please note: This is onsite in Chicago, IL 60642 (with 25% local travel within Chicago) This role is a potential temp to hire International Travel: 1 trip to Rotterdam (2 weeks) at the start of the project for training * Employment Type: W-2 Overview: Support a product improvement initiative for company s product. Focus on developing and improving thermal processes to enhance product taste and quality. Key Responsibilities: The role will be the bridge between the pilot plant an

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join us as an AI Engineer to implement innovative AI and ML methods for our GxP Quality Management System. Key Responsibilities: Build AI Solutions: Develop predictive models, anomaly detection systems, and LLMs to optimize QMS performance.Improve GenAI and LLMs: Apply Generative AI techniques and LLMs to automate and improve tasks like quality events analysis, document reviews, and complaint management.Work wit

Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTub

Senior Validation Engineer: Pharmaceutical experience, ideally with cleaning validation expertise. From the manager . For the validation role, I would love to get someone with cleaning validation experience to help me change the way we do cleaning. Currently, we do a quick validation on every solution and piece of equipment. I would like to move to a risk-based approach where we evaluate new products and equipment against the current worst-case to determine what needs to be done. It s a big c

Full-time Job opportunity in the Chicago area with an innovative healthcare technology company building cutting-edge medical device software that improves heart care through data science and advanced technology. As a Platform Security Engineer, you'll be working with cloud infrastructure (primarily Google Cloud Platform), security automation tools, and compliance frameworks to protect critical healthcare applications and patient data. This is your chance to make a meaningful impact in healthcare

Stefanini Group is hiring! Stefanini is looking for Reliability Performance Engineer in Deerfield, IL (Hybrid) For quick Apply, please reach out to Kamal Rawat - call: / email: Work Hours: M-F (40 hours) Work Location: Deerfield, IL (Hybrid) Shift: 1st Shift Reliability Performance Engineer develop and execute testing documentation and scripts that validate and verify both physical and digital medical products. This role will be responsible for designing, implementing, and managing test protoco

Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Laboratory Setting, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. At Thermo Fisher Scientific, each one of our 100,000 plus extraordinary minds has a unique sto

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. The Opportunity This position works out of our Des Plaines, IL location in Abbott Molecular Diagnostics. Abbott Molecular Diagnostics is a leader in m

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Sr. Manager, Third Party Manufacturing Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your famil

Job Summary The Senior Packaging Engineer will lead the design, development, and implementation of packaging solutions for our medical devices. This role requires a deep understanding of packaging materials, regulatory requirements, and industry standards. The ideal candidate will have a strong background in packaging engineering, project management, and cross-functional collaboration, preferably within the medical device industry. Job Description Responsibilities: Lead the design and develop

Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTub

KFORCE URGENT REQUIREMENT Looking for candidates regarding the following: POSITION Sr Full Stack Engineer LOCATION Remote DURATION 6+ months INTERVIEW TYPE Video VISA RESTRICTIONS None REQUIRED SKILLS 5+ years of experience working in a SaaS-based product development environment or FDA-regulated medical device environmentExperience with programming languages Java, JavaScript, and SQLMust have SaFE Agile framework experienceSpring BootAngular

Hi, Here is an Remote Contract Job opportunity for below position. Role: SAP Plant Maintenance (PM) Consultant Location: IL, Remote + (Occasional Travel) Contract Duration: 12+ Months Experience: 10 + Year skills compliance with food industry standards (e.g., FDA, GMP, HACCP) Regards, Nirmal Kumar Phone:- Email:-

Piper Companies is Senior Manager for Regulatory Affairs Labeling Strategy to join the team a global biopharmaceutical company focused in neurology and immunology. In this role, you will lead labeling strategies, ensuring compliance with regulatory requirements while supporting product development and commercialization. This preferred candidate will be located in the Atlanta, GA or Raleigh, NC regions, however candidates outside of these regions will be considered as well. Responsibilities of

Position: Sr. Full Stack Engineer Location: Remote Duration: 6+ Months (Contract) Job Overview: We are seeking a Sr. Full Stack Engineer to join our growing team and contribute to the development of cutting-edge SaaS solutions. This is a fully remote role ideal for experienced engineers with a strong background in Java, JavaScript, and SQL, and who are comfortable working in fast-paced, Agile-driven environments. Candidates with experience in FDA-regulated medical device development or SaaS prod