2mo
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Project Engineer 3
Marlborough or Louisville
$98k-$153k/yr OnsiteFull Time
3+ YOEBachelor’s degree in Engineering; 3+ years project management; regulated medical device experience preferred; FDA/ISO knowledge; PMP preferred.
PMO tools, Gantt charts, risk registers, design history file (DHF) documentation
1d
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Senior Quality Control Specialist
Boulder, Colorado, United States
$128k-$155k/yr OnsiteFull Time
4+ YOE4+ years QC experience in biotech/pharma (GMP) with ability to perform analytical methods, interpret stability data, and follow FDA/ICH cGMP requirements.
IP-RP-UPLC, SAX-HPLC, GC, Mass Spec, FTIR, UV
3w
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Paramedic/EMT-P
Loveland, Colorado, United States
$28-$39/hr OnsiteFull Time
2+ YOEState EMT-Paramedic licensure, CPR/AED and IV therapy competence, FDA BioLife Medical Support Specialist training, and 2 years clinical/hospital experience.
1w
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Prin Regulatory Affairs Spec
North Haven or Mansfield or Mounds View or Boston or Lafayette
$120k-$180k/yr OnsiteFull Time
7+ YOEBachelor's degree and 7+ years regulatory experience (or advanced degree with 5+ years). Experience with 510(k), FDA interactions, international registrations, labeling and promotional material review.
1w
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Plant Manager
Denver or Clinton Township
OnsiteFull Time
10+ YOE10+ years leadership in injection molding or advanced manufacturing, expertise in scientific molding, Lean/Six Sigma, regulated environments (ISO 13485/FDA/ITAR), automation and financial management.
RJG, Lean Manufacturing, Six Sigma
3mo
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FSQA Manager
Denver, Colorado, United States
$86k-$142k/yr OnsiteFull Time
5+ YOE1+ Mgmt5+ years in food manufacturing/FSQA; Bachelor's in Food Science, Microbiology, Engineering, or related field; strong FDA/USDA, FSMA, HACCP knowledge; proven problem-solving and leadership.
3w
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Staff Software Engineer, Valence
Louisville, Colorado, United States
$130k-$145k/yr OnsiteFull Time
8+ YOE8+ years in surgical navigation or medical device software; proficiency in C++ on Linux, 3D geometry and imaging, image processing toolkits, experience in FDA-regulated environments, strong leadership and communication.
C++, Linux, Qt, DICOM, VTK, ITK, OpenCV, GIT, Azure DevOps
1mo
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QA Product Specialist
Boulder, Colorado, United States
$100k-$118k/yr OnsiteFull Time
5+ YOEBachelor's in science and 5 years pharmaceutical QA experience (or equivalent), strong cGMP/cGLP/FDA knowledge, validation and CAPA experience, audit support, technical review and quality leadership skills.
6d
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Validation Engineer
Frederick or Boulder
$82k-$129k/yr OnsiteFull Time
1+ YOEBachelor's in engineering or life sciences,1+ years relevant experience,knowledge of cGMP/FDA/ICH regulations,validation experience (IQ/OQ/PQ/SAT),CAPA and change control experience.
URS, Software Acceptance Testing (SAT), IQ, OQ, PQ, GAMP, 21 CFR, ICH, Eudralex Volume 4 Annex 15, CAPA, spreadsheets
1d
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Consultant II
Boston or San Diego or Boulder or India
RemoteFull Time
3+ YOEBachelor's in life sciences/regulatory required, 3–5 years pharma/biotech regulatory experience, promotional review expertise, strong FDA/Health Canada knowledge, project management and communication skills.
1mo
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Clinical Pharmacist
Fort Collins, Colorado, United States
$48-$57/hr OnsiteFull Time
2+ YOECurrent Colorado pharmacist license, BPharm or PharmD degree, Colorado driver's license and transportation, sterile compounding competency, adherence to USP/OSHA/FDA/board standards, ability to work independently and on-call.
1mo
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Production Worker
Greeley, Colorado, United States
$15-$19/hr OnsiteFull Time
Able to lift up to 50 lbs, stand for extended periods, perform repetitive packing and basic math, operate production machinery safely, follow OSHA/FDA guidelines, and work overtime/weekends as needed.
2mo
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Senior Architect - Life Sciences
Lenexa or Broomfield
$100k-$115k/yr OnsiteFull Time
Licensed architect preferred, NAAB education, deep cGMP life sciences experience, team leadership, BIM/Revit proficiency, knowledge of IBC/NFPA/ADA/FDA cGMP, strong communication and presentation skills.
Revit, Bluebeam Revu, Navisworks, AutoCAD, Microsoft Office Suite
2d
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FSQA Manager
Louisville, Colorado, United States
$80k-$105k/yr OnsiteFull Time
5+ YOE3+ MgmtAssociate degree in a related field, 5+ years related experience with 3+ years management, HACCP and PCQI training, knowledge of FDA FSMA and food manufacturing QA, strong communication and decision-making skills.
1w
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Associate Director, Clinical Operations
Waltham or Boulder
$185k-$215k/yr HybridFull Time
6+ YOE6+ years clinical development experience, BS/BA preferred, experience leading multi‑phase trials, CRO/vendor management, GCP/ICH/FDA knowledge, SOP development, and ability to travel ~25%.
3w
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Quality Management System Manager
Boulder, Colorado, United States
$115k-$135k/yr OnsiteFull Time
5+ YOEBS required; 5+ years in quality management in advanced manufacturing; strong knowledge of ISO standards and FDA QSR; experience with NPI, root cause analysis, CAPA, supplier quality; Six Sigma/Lean preferred.
Microsoft Office, SPC, Pareto Diagrams, Affinity Diagrams, Fault-Tree Analysis, Design of Experiments
3w
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Validation Engineer II
Windsor, Colorado, United States
$90k-$100k/yr OnsiteFull Time
2+ YOEBachelor's in engineering or life sciences, minimum 2 years validation experience in sterile pharma, cGMP/FDA/EU knowledge, Microsoft Office proficiency, strong technical writing, project management, and aseptic/cleanroom familiarity.
Microsoft Office
1mo
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Cylinder Filler - Denver, CO
Denver, Colorado, United States
$24-$26/hr OnsiteFull Time
1+ YOEHigh school diploma; 1+ years gas/welding or warehouse experience preferred; ability to operate forklift, lift 50+ lb, read MSDS, follow OSHA and FDA procedures, and complete production documentation accurately.
forklift
1mo
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Senior Manager, Nutrition & Scientific Affairs
Louisville or White Plains
$118k-$169k/yr HybridFull Time
6+ YOERegistered Dietitian with 6+ years in nutrition science or scientific affairs, advanced degree in nutrition or related field, experience with claim substantiation, familiarity with US regulatory frameworks (FDA, FTC), strong cross-functional leadership and communication.
5d
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Production Worker General Labor- 2nd Shift
Westminster, Colorado, United States
$18-$23/hr OnsiteFull Time
Follow GMP/food safety and USDA/FDA/FSMA standards, operate and change over machinery, lift up to 50 lbs, stand up to 12-hour shifts, perform repetitive production tasks with attention to detail.