URS Jobs in Pennsylvania

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CQV Engineers Needed - Spring House, PA_Onsite job

Stellent IT LLC

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Spring House, Pennsylvania, USA

Third Party, Contract

Hiring for - TITLE - CQV Engineers - Spring House, PA_Onsite job They are going to need 25-30 CQV Engineers to assist on this project. Initial 6 12-month project. The areas of focus will be on Cell Therapy and Temperature mapping Need - LINEKDIN match with updated resume, no FAKE people Multiple CQV Engineers needed to support a project in Spring House, PA. The scope includes thermal mapping and qualification of various GMP equipment, with a strong focus on controlled temperature units and lab
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Posted 6 days ago | Updated 8 hours ago

Compliance Lead

Adva IT Services, Inc..

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Remote

Contract

Key Responsibilities Lead the design and execution of the company s compliance framework, covering GxP areas (GMP, Google Cloud Platform, GLP) and validated system lifecycle activities. Ensure compliance with SDLC processes for GxP-relevant computerized systems, including documentation, validation, change control, and audit readiness. Develop and maintain SOPs and training programs related to software/system validation and data integrity (e.g., per 21 CFR Part 11 and Annex 11). Provide complianc
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Posted 6 days ago | Updated 1 day ago

CQV Engineer

Katalyst Healthcares and Lifesciences

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Pittsburgh, Pennsylvania, USA

Full-time

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
Posted 20 days ago | Updated 6 hours ago

CQV Engineer

Katalyst Healthcares and Lifesciences

•

Pennsylvania, USA

Full-time

Responsibilities: The areas of focus will be on Cell Therapy and Temperature mapping. Preparation and execution of Qualification Protocols and Reports. Design Qualification (DQ). Installation Qualification (IQ). Operational Qualification (OQ). Performance Qualification (PQ). Review and/or authoring of supporting validation documentation. User Requirements Specifications (URS). Risk Assessments (e.g., SIA). Commissioning Test Report. Thermal mapping strategy definition and execution. Execution of
Posted 2 days ago | Updated 6 hours ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

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Remote or Massachusetts, USA

Full-time

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
Posted 27 days ago | Updated 6 hours ago

Commissioning & Qualification (C&Q) Engineer

Katalyst Healthcares and Lifesciences

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Harrisburg, Pennsylvania, USA

Full-time

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
Posted 60+ days ago | Updated 6 hours ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

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
Posted 60+ days ago | Updated 6 hours ago

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

Stellent IT LLC

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Harrisburg, Pennsylvania, USA

Contract, Third Party

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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Posted 60+ days ago | Updated 8 hours ago

Pharmacovigilance Business Analyst

Cygnus Professionals

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Remote

Full-time

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