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Pittsburgh, Pennsylvania

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Today

Job Description: Our client is currently building (started in 2024) a 125,000 sq ft greenfield manufacturing facility outside of Pittsburgh, PA. Expected to be operational by 2027 Q1. The electricity gets turned on in this facility in the end of Jan 2026. The facility will be state of the art and will be in partnership with U of Pitt. It will be focused on Gene Editing, iPSC tech, and cell, vector and protein engineering capabilities. Our client is looking to add an Owner's Rep CQV Engineer to h

Full-time

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

Commissioning & Qualification (C&Q) Engineer

Harrisburg, Pennsylvania

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Today

Responsibilities: Develop and execute commissioning protocols (FAT, SAT, IQ, OQ and PQ) for equipment, systems, and facilities. Perform system startup, debugging, and initial testing of process and utility systems. Ensure that systems are installed and operating according to design specifications. Collaborate with engineering, manufacturing, and quality teams during equipment installation and commissioning. Review and verify system documentation, such as P&IDs, wiring diagrams, and datashee

Full-time

Systems Administrator

Remote or Salt Lake City, Utah

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Today

Announcement Details Open Date 06/13/2025 Requisition Number PRN42189B Job Title Systems Administrator Working Title Marketing Automation Specialist Job Grade F FLSA Code Computer Employee Patient Sensitive Job Code? No Standard Hours per Week 40 Hours Full Time or Part Time? Full Time Shift Day Work Schedule Summary This is a remote position VP Area Academic Affairs Department 02218 - Data and Software Solutions Location Other City Salt Lake City, UT Type of Recruitment Externa

Full-time

USD 70,000.00 - 82,500.00 per year

Computer System Validation Analyst - R Studio & Clinical Systems

Remote or New Jersey

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Today

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana

Full-time

C&Q Engineer - (Commissioning & Qualification) || Harrisburg, PA (Onsite)

Harrisburg, Pennsylvania

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Today

Position: C&Q Engineer Location: Harrisburg, PA (Onsite) Duration: 12+ month contract Multiple Openings - Standard C&Q profile ideally with 7+ years' experience. More experience the better Job Description :- We are looking for a highly skilled Senior Commissioning & Qualification (C&Q) Engineer to support our Life Sciences projects. The ideal candidate will have extensive experience in qualification and validation activities, ensuring compliance with industry regulations and best practices.

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Contract, Third Party

Pharmacovigilance Business Analyst

Remote

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12d ago

Position Title: Pharmacovigilance Business AnalystLocation: Remote Duration: 12 plus months contract or Fulltime Requirements: Bachelor's degree in Statistics, Mathematics, Computer Science, Life Sciences or a related field.Minimum 10+ years of Business Analyst experience is required.Clinical Trial domain expertise, including Study Execution, Site Monitoring, Data Management, and Patient Safety.Exposure to Pharmacovigilance, and Quality and Compliance processes preferred.Experience with SQL and

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Full-time

Depends on Experience

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