- Merck (Rahway, NJ)
- …and post-market commercial manufacturing support. BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) including ... to internal and external manufacturing sites, manufacturing investigations, process validation , second generation process development and authoring of regulatory… more
- System One (Paulsboro, NJ)
- Job Title: Validation Engineer Location: West Deptford, NJ Type: Direct Hire (Full-Time) Overview A leading manufacturing organization specializing in regulated ... industries such as pharmaceuticals and biotech is hiring a Validation Engineer. This position offers the opportunity to lead critical validation projects and be… more
- System One (Piscataway, NJ)
- Job Title: Validation Engineer Location: Piscataway, NJ Hours / Schedule: Monday - Friday, 8 AM - 5 PM (some flexibility required) Type: Contract-to-Hire/ Direct ... field). + Minimum 4+ years of experience in facilities validation , commissioning, and qualification (CQV) in the pharmaceutical or...Deionized Water, a big plus + Strong knowledge of FDA , EU GMP, ICH Q7, ISPE Baseline Guides, and… more
- Mentor Technical Group (NJ)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... Germany, Canada, and South America. Responsibilities: Develop and execute validation protocols: Create and implement protocols for equipment, processes, cleaning,… more
- Sanofi Group (Bridgewater, NJ)
- …teams to ensure that all integration processes adhere to the required validation protocols for FDA -compliant systems. Provide documentation and support for ... strategies) systems are operating efficiently and in compliance with FDA regulations, while also enabling smooth data flows between...while adhering to regulatory compliance (21 CFR Part 11, FDA REMS guidelines). + Work closely with QA and… more
- Lilly (Branchburg, NJ)
- …documentation supporting the manufacturing automated systems; 4 years of experience with supporting validation according to FDA or EU regulations; 4 years of ... lead qualification and requalification activities for CSV (computerized systems validation ) for automated process control equipment and computerized systems.… more
- Terumo Medical Corporation (Somerset, NJ)
- …to SAP software Some familiarity with SOX and IRM compliance Some familiarity with FDA CFR Part 11 Software Validation processes Keen analytical skills Keen ... work with the Record to Report Team for Integration design from Financial Validation perspective. Work with other Process Track leaders to manage design efforts for… more
- J&J Family of Companies (Titusville, NJ)
- …working with subject matter experts within the department. + Understand CLIA-laboratory, FDA testing guidelines and assay validation requirements; keep current ... knowledge and understanding of design control process, analytical and clinical validation , manufacturing, GCP, GLP, and GMP requirements, Global IVD regulations and… more
- Terumo Medical Corporation (Somerset, NJ)
- …SAP software + Some familiarity with SOX and IRM compliance + Some familiarity with FDA CFR Part 11 Software Validation processes + Keen analytical skills + Keen ... baselines to ensure consistency of + Support SAP COE in testing and validation efforts related to Maintenance Patches, Version Upgrades and integration on New… more
- Terumo Medical Corporation (Somerset, NJ)
- …(KSA)** + Medical Device/Serialized product experience is required + Some familiarity with FDA CFR Part 11 Software Validation processes + Keen analytical skills ... + Keen sense of maturity, judgment and diligence required to: + Secure company's financial interests; and, + Avoid exposures to expensive delays and cost overruns. + Strong inter-personal and communication skills + Ability to cope with stress and continuously… more