Job Title: Sycamore SCE Administrator (Statistical Computing Environment) Location: Hybrid at Boston, MA Job Type: C2C / Full time Overview: We are seeking an experienced Sycamore SCE Administrator to manage and maintain our Statistical Computing Environment (SCE) used for clinical and statistical analysis. The ideal candidate will have deep hands-on experience with the Sycamore platform and a strong background in statistical computing within regulated environments such as pharmaceuticals or lif

Hi Please sendin resume and ph# Business Quality Assurance (BQA) Location = Indianapolis, IN / remote Total Yrs. of Experience - 10-12 YEARS Relevant Yrs. of experience - 7 to 12 years Mandatory skills Strong knowledge in GMP, cGMP, regulatory standards (21 CFR Part 11, 21 CFR Part 210, 21 CFR Part 211, ICH Q7) Experience in facing FDA audits associated with pharma manufacturing units Hands-on experience with manufacturing processes, CAPAs, deviations etc. Lead Auditor or any other compliance c

Computer System Validation Engineer (CSV) SFO, CA Onsite Contract Client : Cellares Minimum 10+ Years experience required .5 year in Pharma domain Job Roles and Responsibilities: * Develop, execute, and document test protocols for system qualification, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). * Ensure that software is properly validated and compliant with internal and external standards, such as FDA 21 CFR Part 11, GxP, an

Location: Denver, CO Salary: $65.00 USD Hourly - $75.00 USD Hourly Description: About the job Join a global medical-device & cell-therapy organization as a Senior SDET / Data-Quality Engineer. You'll automate data-quality pipelines on our Azure/Databricks lakehouse to ensure regulatory-grade, analytics-ready datasets for upcoming post-market analytics releases. Responsibilities Design, develop, and maintain automated data-validation frameworks for batch & streaming pipelines in Databricks.

Our client, a leading pharmaceutical company, is hiring a MES Engineer, on a contract basis. Job ID #: 82365 Work Location: New Brunswick, NJ - 50% on site Summary: Seeking a Senior MES Engineer/Validation Lead to take ownership of computer system validation activities for Manufacturing Execution Systems (MES) supporting cell therapy manufacturing. This role is ideal for someone with a strong IT/Computer Science foundation and 3 years of hands-on experience in the pharma/biotech industry. Youll

Job Title: MES Engineer Job ID: 25-07988 Location: Summit, NJ Duration: 06 Month s Contract on W2 Candidates must be onsite 50% of the time at either Summit West, Giralda Farms, Princeton Pike, Lawrenceville, or New Brunswick. Must Have List4+ years of Computer System Validation (CSV) experience in regulated pharmaceutical and biotech environments, with strong knowledge of GAMP 5, 21 CFR Part 11, and Computer Software Assurance (CSA) principles.3+ years of hands on MES experience with Emerson S

Piper Companies is hiring a MES Engineer (Syncade) for a biomanufacturing hub locate din Holly Springs, NC. The MES Engineer (Syncade) will be supporting the integration and configuration of Emerson DeltaV MES for two manufacturing facilities, ensuring compliance with cGMP standards and paperless workflows. The MES Engineer (Syncade) is a long term contract opportunity and will require the candidate to work on site in Holly Springs, NC 4 days per week. Responsibilities of the MES Engineer (Sync

Computer System Validation (CSV) Engineer with strong knowledge of FDA and cGMP regulations and documentation practices and 21 CFR Part 11. needed! (**Full relocation provided**) This Jobot Job is hosted by: Ryan Sullivan Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $130,000 - $145,000 per year A bit about us: We are a fast-growing, Medical Device Manufacturer in Scottsdale, AZ, passionate about improving the lives of patients suffering

Primary Talent Partners has a 6 month contract opening for a MES Engineer to join a major pharma client for a position.Pay: $55.00-60.00/hr based on experience and academia W2 Contract: 6 months, extensions likely, conversion possible Type: W-2, cannot support C2C or provide visa sponsorship Location: Onsite - Summit, NJOverview: We re seeking a Senior MES Engineer/Validation Lead to take ownership of computer system validation activities for Manufacturing Execution Systems (MES) supporting cel

Job Title: NetSuite Analyst Job Location: Louisville, Colorado 80020 Onsite Requirements: Biotech / Pharmaceutical / Life Sciences industry experience. NetSuite, Coupa, and Veeva regulatory guidelines such as FDA 21 CFR Part 11 Job Description: POSITION SUMMARY We're looking for an information Technology (IT) analyst to support our Enterprise Systems. This role will report to the Director of IT Enterprise Systems and will provide technical support, maintenance and enhancement of solutions for F

Sr. Veeva QMS Support Analyst San Francisco, CA Type: Contract Length: 3 months, maybe extensions Job Summary: We are seeking a detail-oriented and technically skilled Veeva QMS Support Specialist to provide end-user support, configuration assistance, and continuous improvement for our Veeva Quality Management System (QMS). This role serves as a bridge between Quality, IT, and end users, ensuring smooth implementation and operation of Veeva QMS modules including Change COntrol, Deviations (QE)

Job Title: Computer System Validation (CSV) Specialist Duration: 08 Months + (Possible Extension) Location: Wilmington, DE 19803 (Remote) Schedule: M-F: 08 AM 05 PM Kindly Do not apply if you are not or Permanent Resident of USA. Qualifications: The official position title is Computer System Validation (CSV) specialist to support the Newark manufacturing facility with validation of new and existing computerized systems.This role will primarily support the Newark manufacturing facility but may r

Location: Remote Job Type: Full-Time / Contract Industry: Life Sciences / Pharmaceuticals / Manufacturing About the Role: We are seeking experienced MES (Manufacturing Execution System) Consultants with strong backgrounds in Electronic Batch Records (EBR) and Master Batch Record (MBR) design, along with hands-on recipe authoring experience. This is a remote position, ideal for professionals with a solid understanding of GMP-regulated environments, especially in pharmaceutical or biotech manufact

MES - Validation Engineer - Contract - Princeton, NJ - $59.44 - $59.44/hr. The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position. Applicants must be legally authorized to work in the United States. Sponsorship not available. Our client is seek

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

We are seeking a highly skilled LabVantage LIMS (Laboratory Information Management System) Architect to design, implement, and optimize LabVantage solutions that meet the complex needs of our organization. This role is critical for ensuring our laboratory operations run seamlessly, with robust systems that enable efficiency, compliance, and scalability. As the LabVantage LIMS Architect, you will collaborate with stakeholders, including laboratory personnel, IT teams, and vendors, to design custo

Work Location: St. Louis, Missouri Shift: No Department: LS-QR-DV Validation Management Recruiter: Kathy Lewison Hiring Manager: Anbukumar Marimuthu This information is for internals only. Please do not share outside of the organization. Your Role: In this role, you will be the Digital Platform Senior Validation Engineer. This position is responsible for the guidance and direction of validation projects covering all the Life Science digital products, applications, and computerized systems. Yo

Piper Companies is seeking a BioPharma Electrical/Automation Subject Matter Expert (SME) to manage the construction and communication of a new facility build for a CDMO out in Bloomington, IN. The role has an onsite expectation and slated through 2026 and potentially beyond. The SME will provide technical leadership and subject matter expertise throughout the design, construction, commissioning, and qualification of a new pharmaceutical manufacturing facility. This role will be responsible for e

Description We are seeking a highly skilled and proactive Application Support Manager to lead the support and maintenance of enterprise applications, with a strong focus on SAP BusinessObjects (SAP BO) and other general business systems. The ideal candidate will have deep expertise in SQL and a proven ability to manage cross-functional support initiatives. Prior experience in the pharmaceutical or biotechnology industry is highly desirable. Key Responsibilities: Lead the application support fun

Mandatory Skills - Computer System Validation, GxP Regulations, Validating GxP systems Job Details: 10 years' experience in Computer System Validation ERP/WMS, R&D systems A senior consultant with expert knowledge of GxP and Computer System Validation. Expertise in authoring and reviewing all CSV validation deliverables. Proficient in Compliance Plan, User Stories, Testing, Traceability Matrix and SDLC lifecycle activities. Knowledge in utilizing SDLC tools such as JIRA, AM, qTest, X-ray etc. K