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Remote or New York

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Today

Lead IT Validation Consultant Remote Notes : Prior experience in CROs, clinical research organizations, or pharmaceutical/biotech companies. Knowledge of laboratory processes such as PK, TK, and biomarker studies. Experience with integration of LIMS with other lab or enterprise systems (e.g., CDS, ELN, CTMS).Validation or QA certifications a plus. JD: We are seeking an experienced IT Validation Consultant to lead and support the validation of Laboratory Information Management System (LIMS) used

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Contract, Third Party

Sr Process Design Engineer/Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast)

Remote

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Today

Sr Process Design Engineer / Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast) This Jobot Job is hosted by: Tony Barhoum Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $115,000 - $150,000 per year A bit about us: We are a full-service engineering consulting firm providing services for a broad range of projects and clients within the private and public marketplaces. Our design engineers provide cost-conscious, reliable, HVAC, plumbing

Full-time

USD 115,000.00 - 150,000.00 per year

Sr Process Design Engineer/Technical Lead (Pharma/cGMP/FDA) - Remote (East Coast)

Remote

•

Today

Full-time

USD 115,000.00 - 150,000.00 per year

LIMS and QC Applications Consultant

Remote or Hybrid in Bridgewater, New Jersey

•

Today

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

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Full-time, Contract

BASED ON EXPERIENCE

Document Management Specialist | Remote | Contract

Remote

•

Yesterday

Document Management Specialist | Remote | Contract Walker Healthforce is seeking a Document Management Specialist with +4 years of experience. This is a contract opportunity. CORE REQUIREMENTS:An A.A. in Business or English (or related) with four (4) years of experience OR Bachelor of Arts degree.Strong writing skills with good grammar.Attention to detail.Able to work on multiple documents in parallel.Able to create simple forms and templates.Must be able to use MS Office tools and interact with

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Contract

Depends on Experience

Commissioning and Qualification Engineer

Raleigh, North Carolina

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Today

Responsibilities: Lead or support C&Q activities for pharmaceutical utilities and process equipment, ensuring compliance with industry standards and regulatory requirements. Execute FAT (Factory Acceptance Testing) to validate equipment functionality and performance. Support the qualification of Black and Clean utilities, such as water systems, clean steam, HVAC, and gas utilities. Perform process equipment qualification to meet GMP and production readiness standards. Develop and execute C&Q pro

Full-time

MES Automation Support Engineer

Raleigh, North Carolina

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Today

Job Title:- MES Automation Support Engineer Job Location:- Holy Springs NC (Onsite) Long Term Contract Position Overview: We are seeking a MES Automation Support Engineer to support the development and deployment of a DeltaV MES (Syncade) platform, enabling fully digital manufacturing with integrated ERP, MES, and DCS systems at a cutting-edge CDMO site. This role will involve collaborating closely with cross-functional teams to drive paperless operations and enforce validated workflows. Ke

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Third Party, Contract

$market rate

Sr. SAS Programmer

Durham, North Carolina

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Today

Responsibilities: The Sr. SAS Programmer will be responsible for statistical programming for the client's clinical studies. In this role, you will develop and validate SAS programs for data presentation, analyses, and provide programming support to project team members. Our Ideal candidate will have a strong work ethic capable of thriving in a high growth, fast paced and intellectual environment. Serves as lead programmer for assigned projects to provide statistical and programming support i

Full-time

CQV Engineer(Onsite) Location: Holly Springs, North Carolina

Holly Springs, North Carolina

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Today

CQV Engineer (Onsite) Location:Holly Springs, North Carolina Interview:Phone+Skype Job Description: Upstream/downstream process and CQV support (ex. autoclaves, parts washers, incubators, Isolators, HVAC) Managing and working collaboratively with clients' quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Includes ability to complete root cause analysis Supporting clients change management program includin

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Third Party, Contract

Sr Manufacturing Maintenance Tech - Night Shift

Durham, North Carolina

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Today

Benefits at bioMerieux: Low-cost medical, dental, and vision benefits starting day one 11 paid holidays 160 hours of paid time off Annual bonus 9.5% 401k company contribution with no vesting period Tuition reimbursement up to $10,000 per calendar year Onsite cafeteria with daily food stipend Position Summary & Responsibilities: The normal working hours for this role are anticipated to be 7:00pm - 7:30am working a 2-2-3 schedule. The Sr. Maintenance Technician is responsible for direct support

Full-time

Validation Engineer

Durham, North Carolina

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Today

Job Description: Reporting directly to the division Sterilization Quality Engineer Lead, this position involves support for the sterilization operations and product sterility assurance program. This position provides quality guidance for product and process sterility, product resolution decisions, and statistical problem-solving techniques to manufacturing operations and project teams for new product introduction, process improvements, continuous improvements, and validation activities. This

Full-time

Systems Engineer I/II - Server Admin (QC Support)

Clayton, North Carolina

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Today

About the Department You will be joining Fill & Finish Expansions (FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20,000 of Novo Nordisk's 50,000 employees. FFEx is a newly established and growing area with the responsibility to design, plan, and build

Full-time

Manufacturing Engineer

Raleigh, North Carolina

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Today

Flowserve is a world-leading manufacturer and aftermarket service provider of comprehensive flow control systems. Join a company whose people are committed to building a more sustainable future to make the world better for everyone. With 16,000+ employees in 50+ countries, we combine our global reach with local presence. Our team challenges themselves to approach each situation with ingenuity and creativity to help provide our customers with the most innovative flow control products and services

Full-time

SAP GTS Business Function Implementation Lead (Remote Work)

Remote

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8d ago

We are seeking an experienced SAP GTS Consultant with expertise in Global Trade Services (GTS), including full lifecycle implementations and hands-on configuration in SAP GTS E4H. The ideal candidate will have deep functional knowledge of compliance management, customs processes (exports/imports), and GTS master data, particularly in trade between the Dominican Republic (DR) and the US.This is a client-facing, lead role requiring strong project leadership, ability to drive results, and hands-on

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Contract, Third Party

$75 - $80

IT Validation Consultant

Remote

•

Today

Title: IT Validation Consultant with experience in Clinical Research Organisation/ Pharmaceutical/Biotech companies Duration: Contract Work Location: Remote Notes: Prior experience in CROs, clinical research organisations, or pharmaceutical/biotech companies. Knowledge of laboratory processes such as PK, TK, and biomarker studies. Experience with integration of LIMS with other lab or enterprise systems (e.g., CDS, ELN, CTMS).Validation or QA certifications a plus. We are seeking an experienced I

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Contract, Third Party

$40 - $50

Senior Biostatistician: Pharma experience / Remote

Remote

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Today

Biogensys is currently hiring Senior Biostatistician with Pharma experience for 6 to 12 months contract on w2. This is a remote position, no corp to corp, or 1099. No sponsorship is available. Senior Biostatistician: Pharma experience / Remote- At least 9-10 years of experienceLead statistical aspects of clinical studies from design to final reportingReview and approve programming deliverables (ADaM datasets, tables, listings, and figures)Proven expertise in SAS and/or R for statistical analysis

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Contract

Depends on Experience

Principal Regulatory Consultant Dietary Supplements

Remote or New Jersey

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8d ago

Job Description: Job Title: Principal Regulatory Consultant Dietary Supplements (U.S.-Based) Position Type: Contract / Consulting Location: Jersey City, NJ Department: Regulatory Affairs / Corporate Development Position Summary: We are seeking a highly experienced and credentialed Regulatory Consultant to support strategic M&A due diligence initiatives within the dietary supplement industry. This role demands deep understanding of the U.S. regulatory landscape, including DSHEA, FDA cGMPs (21 CFR

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Third Party, Contract

Document Management Specilist (W2 Only - 100% Remote)

Remote or Hybrid in Rochester, Minnesota

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Today

Learn Division of Engineering tools and expectations.Document controls system (SolidWorks PDM) structure, navigation, and use.Engineering change order process.Document templates.Assist with document revisions from annual review. For each document:Accept redlines from document owner (facilitate review?).Review documents and suggest further incremental improvements.Verify reference documents section.Documents referenced in text are included in reference section.Documents in reference section exist

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Contract

$40 - $45

Computer System Validation (CSV) Engineer

Remote or Massachusetts

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Today

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. Author and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's

Full-time

CQV Engineer

Remote or New Jersey

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Today

Job Description: We are seeking a highly motivated and experienced CQV Engineer to join PharmEng Technology, a leading global provider of engineering and consulting services to the pharmaceutical and biotechnology industries. The CQV Engineer will lead commissioning, qualification, and validation activities for new and existing pharmaceutical facilities and equipment. Responsibilities: Develop and execute commissioning, qualification, and validation protocols for new and existing pharmaceutical

Full-time

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