21 CFR jobs in Remote

Billerica, Massachusetts

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9d ago

Process Engineer IIWe are seeking an experienced Process Engineer II to support radiopharmaceutical manufacturing operations. In this role, you will provide technical support to automated manufacturing lines, troubleshoot process and equipment issues, lead deviation investigations and CAPAs, and support process validation, equipment qualification, and continuous improvement initiatives. You will work closely with Manufacturing, Quality, Engineering, and Supply Chain teams to ensure safe, complia

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Contract

Depends on Experience

GxP Project Manager (Pharma)

Hybrid in San Francisco, California

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4d ago

Job Title: GxP Project Manager Location: Bay Area, CA Duration: 6+ months with possible of extension Required Qualifications Bachelor's degree in Engineering, Computer Science, Life Sciences, Pharmacy, Biotechnology, or related field.8+ years of Project Management experience within the Pharmaceutical or Biotechnology industry.5+ years managing GxP-regulated projects.Strong understanding of GMP, GxP, GAMP 5, FDA regulations, and 21 CFR Part 11.Experience managing Computer System Validation (CSV)

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Third Party, Contract

$80 - $90

CSV Validation Lead

Hybrid in Raritan, New Jersey

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3d ago

Role CSV Validation Lead Location -Raritan, NJ(Hybrid) Job Details: 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on experience in retro-validation activities and 21 CFR remediation projects with knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness. Experience in the Pharmaceutical, biotechnology, or medical device industry. Experience in FDA and/or Global regulated environment with good understanding of GxP standa

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Contract

Depends on Experience

Senior Test Method Validation (TMV) Subject Matter Expert (SME) / Lead

Delaware City, Delaware

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13d ago

Less of a LEAD and MORE of an SME Hands On Senior Level Subject Matter Expert ONSITE Title: TMV Engineer SME Daily duties of the contractor: TMV Engineer/specialist Key Requirement and experience: Develop and validate test methods for complex electromechanical medical device systems to verify essential clinical and system performance requirements. Demonstrate expertise in converting design and clinical requirements into repeatable, reproducible, and validation-ready test methods, including de

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Contract

$50 - $55

Auditor

Remote or Chicago, Illinois

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Yesterday

Job Title: Quality Auditor Locations: Remote (50 - 60% Travel is expected anywhere in US but that will be sponsored) Duration: 6 months Contract Pay Range: $40 - $43/hr. Must Have's 8+ years of Quality Assurance and Quality Auditing experience within the medical device or pharmaceutical industry Extensive experience leading supplier/vendor audits from planning through final reporting Expert knowledge of FDA regulations (21 CFR Parts 210, 211, and 803), ISO 13485, and Quality Management Systems

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Full-time

$40.0000 - $43.0000

Lab Support IT Administrator

Wilmington, Ohio

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3d ago

Employment Eligibility Statement: Due to specific project and client requirements, this position is open to U.S. Citizens and U.S. Lawful Permanent Residents (Green Card holders). Sponsorship is not available at this time. Danta Technologies evaluates all candidates in compliance with the Immigration and Nationality Act (INA) and EEOC guidelines. All hiring decisions are made without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, vete

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Contract

$28 - $30

OT Security Architect----Bedford, MA -- candidates can work for any Client office--Hybrid

Hybrid in Bedford, Massachusetts

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18d ago

OT Security Architect Bedford, MA -- candidates can work for any Client office Skills: OT--Hands on strong exp risk management pharmaceutical cyber Rockwell PL Ignition SCADA compliance with EU Cyber Resilience Act (CRA) IEC 62443/ISA99 ISA 95 GMP FDA 21 CFR Part 11 Certification--added advantage at least try for few IEC 62443 Cybersecurity Expert GICSP / CISSP Rockwell Automation Sirisha N Sr IT Analyst Humac Inc.

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Contract, Third Party

Depends on Experience

OCM Consultant - MDM

Hybrid in Fort Worth, Texas

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3d ago

Title: Organizational Change Management Consultant - MDM Location: Fort Worth, TX (Hybrid- 3days onsite in a week) Position Overview TheOCM Leadwill drive the people, process, and culture strategy for our globalMaster Data Management (MDM)transformation. In the highly regulated medical device industry, data integrity directly impacts product quality, regulatory compliance, and patient safety. This role focuses on accelerating the adoption of new data governance policies, standardized workflows,

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Contract, Third Party

Depends on Experience

CQV Validation Specialist

Bend, Oregon

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2d ago

CQV Validation Specialist/ CSV/CQV Specialist Location: Bend, OR (Onsite) Duration: 6-9 Month Contract Interview Process: Initial Teams interview followed by a panel interview (Teams or onsite; onsite may be required). Hiring Manager Notes Immediate need due to a significant CQV validation backlog.Strong preference for candidates with analytical laboratory experience.Must be comfortable balancing priorities between CQV and Instrumentation teams.Onsite presence in Bend is required to support in

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Contract, Third Party

Depends on Experience

COMPONENT ENGINEER 3

Sunnyvale, California

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2d ago

Description: Position Overview The Supplier Engineer is responsible for ensuring suppliers reliably support plant production by meeting Intuitive requirements for quality, delivery, capacity, cost, and service. This role is highly execution-focused and serves as the primary technical interface between the plant and suppliers to resolve line-impacting issues, improve supplier manufacturing processes, and maintain stable production operations across multiple product families. The Supplier

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Contract, Third Party

$60 - $75

POMS Techno functional SME

Albany, New York

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25d ago

Role name: POMS Techno functional SME Work Location Albany, New York (On Site) Duration: 12+ Months Role Overview: Role POMS Techno functional SME Experience 8 to 12 Years Domain: Life Science/Pharma & MES Location: Albany, New York (onsite candidates preferred) Job Description: Experienced POMS MES Techno-Functional SME with strong expertise in Manufacturing Execution Systems (MES) within a GxP-regulated pharmaceutical environment. The candidate will act as a bridge between business stakeho

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Third Party, Contract

Depends on Experience

Pharma IT Testing & Validation Delivery Lead

Boston, Massachusetts

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28d ago

Must Have Technical/Functional Skills :8+ years in IT and Quality Assurance.5+ years supporting Pharma/Life Sciences customers.Experience leading global testing services delivery across US, UK, and India.Strong customer-facing and stakeholder management skills.Test Strategy & GovernanceFunctional, Integration, UAT, and Regression TestingData Testing & ValidationRoles & Responsibilities: Own end-to-end Testing & Validation service delivery across multiple Pharma projects Lead onsite/offshore QA t

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Full-time

110,000 - 130,000

QUALITY ENGINEER

Hybrid in Chicago, Illinois

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2d ago

MAJOR RESPONSIBILITIES: Provide Quality expertise in Product Development, QMS, Design Control activities, Design History Files, CAPA, Risk Management, and CE Technical Files. Direct and collaborate with supplier representatives on quality problems, ensure corrective action implementation (CAPA, SCAR), and contribute to supplier quality improvement programs. Lead supplier qualifications. Lead investigations of product and process non-conformances and out-of-specification results and develop ef

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Contract

Depends on Experience

Software Quality Assurance Engineer (Medical Device) - Only On W2

Lake Forest, Illinois

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4d ago

Position SummaryThe Software Quality Assurance Engineer will be responsible for ensuring regulatory compliance and quality assurance for healthcare software products. This role focuses on supporting quality system compliance activities, software validation efforts, risk management processes, and regulatory requirements within a highly regulated healthcare environment. The ideal candidate will work independently, partner with cross-functional teams across multiple geographic locations, and help

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Contract

35 - 40

Clinical Project Manager with RBQM, Veeva, CTMS, eTMF, EDC

Remote

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11d ago

Title: Clinical Project Manager with RBQM & Veeva Foster City, CA or Remote for people who can travel for meetings Experience Range: 10- max 22 years Writeup Skills PM with BA background and experience 6+ years of proven expertise in theclinical domain and operations, including hands-on experience with systems likeCTMS, eTMF, RBQM, and EDC. 8+ years of experience analyzing requirements, documenting findings, and ensuring effective communication and clarification with stakeholders. 6+ years of

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Full-time

Depends on Experience

Senior QC Technician

Oceanside, California

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2d ago

Description: What you will do Create automated laboratory workflows and support development of laboratory recipeswithin the Biovia software system. Collaborate with business stakeholders to gather feedback and propose new functionalities Report defects, test new software features, and support system improvements Design and enhance reporting functionalities and interfaces within laboratory systems Work with end users to design and optimize complex workflows and processes Prepare and maintai

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Contract, Third Party

$28 - $35

Regulatory Affairs Specialist 4

Sunnyvale, California

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2d ago

Primary Function of Position The Sr. Regulatory Affairs primary responsibilities include developing regulatory plans, reviewing design input/output documentation, identification of applicable standards and guidance documents, performing regulatory assessments to determine the impact of design/process changes, preparing regulatory submissions, maintaining regulatory filings and licenses. Essential Job Duties Provide regulatory guidance to product teams, develop regulatory plans, a

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Third Party, Contract

$60 - $60

Quality Management System Manager (Permanent) (On-Site)

Boulder, Colorado

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2d ago

Please note that this is a Permanent, On-Site position with benefits. Relocation package is available. JOB DESCRIPTION: Qualifications: Bachelor of Science degree required, BS in Electrical, Industrial, Mechanical Engineering, Quality Management, or related field. 5+ years of experience in Quality Management within Advanced Manufacturing, Bioscience, Semiconductor, Aerospace, or Defense Industry Environment Strong knowledge of quality standards and regulations (ISO 9001, ISO 13485, ISO 14971,

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Full-time

115,000 - 135,000

SAP QM Consultant (Life Sciences)

Hybrid in Jersey City, New Jersey

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27d ago

Required Skills: 14+ years of SAP QM experience Strong Life Sciences/Pharma/Biotech background SAP S/4HANA experience Expertise in Quality Inspection, Quality Notifications, Batch Management, and QM integration with MM/PP Knowledge of GxP, GMP, and FDA 21 CFR Part 11

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Full-time

Depends on Experience

CQV Engineer

Concord, North Carolina

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Today

Summary: Seeking a CQV Validation Engineer with 5+ years of experience in pharmaceutical, biotech, or life sciences. The ideal candidate will have hands-on experience with Commissioning, Qualification & Validation (CQV) for standalone manufacturing equipment in a GMP-regulated environment. Roles & Responsibilities: Perform CQV activities for standalone equipment. uthor and execute IQ/OQ/PQ protocols, validation plans, and reports. Support FAT, SAT, commissioning, qualification, and validat

Full-time