- Actalent (Shawnee, KS)
- …the microbiology QC laboratory, focusing on method feasibility, development, and validation of all compendial microbiology-related methods for new product transfers ... subject matter expert. Responsibilities + Perform method feasibility, development, and validation for new product transfers. + Develop and validate compendial-based… more
- Sokol Materials & Services (Skillman, NJ)
- …Minimum of 3 years of experience in CQV and/or CSV within the pharmaceutical , biotechnology, cell therapy or medical device industries. + Experience with Cell ... bioreactors, etc.) qualification is a plus. + Strong understanding of validation principles and methodologies, including risk-based validation approaches. +… more
- Merck (Rahway, NJ)
- …transfers across the network inclusive of aligning the control and validation strategies. **Minimum Education Requirements and Experience:** + Bachelor of Science ... (BS) in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with fifteen (15) years relevant experience … more
- Fujifilm (Holly Springs, NC)
- …Biological Science, or related fields, with 3 years of direct Computer System Validation experience in a cGMP pharmaceutical facility working with FDA ... Expert (SME) and leads tasks associated with Computer System Validation (CSV). This role provides input and determine action...5 years of direct CSV experience in a cGMP pharmaceutical facility working with FDA regulations + Experience in… more
- Sokol Materials & Services (Skillman, NJ)
- …degree is preferred. + Minimum of 7 years of CQV experience in pharmaceutical , biotechnology, cell therapy, or medical device industries, with at least 5 years ... focused on utilities and facility qualification. + Strong understanding of validation principles, methodologies, and regulatory requirements, including FDA, EMA, and… more
- J&J Family of Companies (Wilson, NC)
- …Wilson, North Carolina. We are responsible for Process, Thermal & Cleaning Validation , Standardization of Equipment for New Product Introduction, and Life Cycle ... for an MSAT Engineer- Thermal to join our MSAT Validation team ; located in Wilson, NC! **Position Summary:**...**Required:** + A minimum 3+ years experience in a pharmaceutical manufacturing industry or highly regulated industry + Proven… more
- J&J Family of Companies (Horsham, PA)
- …solutions for J&J. EQ is the Subject Matter Expert (SME) for validation /qualification of both applications and infrastructure in accordance with J&J's Systems ... Development Life Cycle (SDLC) and Computer System Validation (CSV) Framework, assuring compliance across the enterprise with applicable global regulations, advising… more
- J&J Family of Companies (Horsham, PA)
- …solutions for J&J. TQ&C is the Subject Matter Expert (SME) for validation /qualification of both applications and infrastructure in accordance with J&J's Systems ... Development Life Cycle (SDLC) and Computer System Validation (CSV) Framework, assuring compliance across the enterprise with applicable global regulations, advising… more
- ThermoFisher Scientific (Greenville, NC)
- …meticulous QA Engineer III to join our Quality Assurance team as a Quality Validation Specialist. The ideal candidate will have a strong background in quality ... validation processes, excellent analytical skills, and a dedication to...5-7 years of experience in quality assurance in a pharmaceutical or similar GMP environment, with at least 3… more
- ThermoFisher Scientific (Greenville, NC)
- …Description** The Staff QA Engineer will lead the quality oversight of validation activities with a strategic focus on continuous improvement and regulatory ... senior-level position involves leadership, mentorship, and high-level coordination of validation processes across multiple sites. **Typical work hours are Monday… more