- Regeneron Pharmaceuticals (Cambridge, MA)
- …providing validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing, and approving ... You will be responsible for planning, executing, and documenting validation activities to meet FDA and potentially...role, you must have at least a** BS/BA in Computer Science, Engineering, Chemistry, or Life Sciences and 5+… more
- Bristol Myers Squibb (Devens, MA)
- …personal lives. Read more: careers.bms.com/working-with-us . **Position: Manager, Validation Engineer, Cell Therapy** **Location: Devens, MA** **Key ... Responsibilities** + Supports equipment qualification and validation activities by providing technical impact assessments and developing sound validation … more
- Sanofi Group (Cambridge, MA)
- …teams to ensure that all integration processes adhere to the required validation protocols for FDA -compliant systems. Provide documentation and support for ... and mitigation strategies) systems are operating efficiently and in compliance with FDA regulations, while also enabling smooth data flows between various systems… more
- AbbVie (Worcester, MA)
- …Historian systems. + Ensure all automation systems comply with regulatory requirements ( FDA , cGMP, etc.). + Mitigates risk within functions through sound design, ... of automation systems. + Maintain documentation including functional specification, validation protocols and change controls. + Experience in change control,… more
- Charles River Laboratories (Shrewsbury, MA)
- …responsibilities include serving as a Principal Investigator for the development and validation of biomarker, PK and ADA assays (eg: ligand binding assays, enzymatic ... would be responsible for the composition and execution of validation and sample analysis protocols/plan in accordance with company...required to talk, hear and work/ type at a computer . * Specific vision abilities required by this job… more
- Integra LifeSciences (Boston, MA)
- …Quality Control Analytical laboratory testing of in-process, finished goods, validation studies, and adherence to all applicable regulations, policies, and ... as needed. + Assist as needed in test method validation , investigation studies or other product development studies. +...(CAPAs). + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties… more
- Philips (Cambridge, MA)
- …+ Leads programs/projects focused on regulatory compliance with UDI requirements, Computer System Validation (CSV) and process improvement by applying/utilizing ... of 7+ years' experience in Regulatory Affairs within Global FDA regulated medical device/technology environments, and a minimum of...the product lifecycle, as well as desired experience in Computer System Validation (CSV) and knowledge in… more
- Teleflex (Mansfield, MA)
- …nonconformances using (NC) process * First article inspections and product/process validation activities * Perform creation and inspection of product identification ... * Support document control activities (Agile updates, work package validation & storage) * Perform IV lab tests *...the medical device industry preferred * Experience with cGMP, FDA regulations, and ISO Quality Systems, strongly desired *… more
- Medtronic (Danvers, MA)
- …of component manufacturing. This includes activities related to test method validation , process validation , inspection improvements, and process/quality change ... development experience in a regulated industry (medical device preferred) + Familiarity with FDA regulations (21 CFR Part 820), ISO 13485, and quality systems +… more
- Hologic (Marlborough, MA)
- …lifecycle, with a focus on software risk management. + Support validation , verification, and clinical preparation activities as required during product development ... and compliance standards. **Qualifications:** + **Education:** + Bachelor's Degree in Computer Science, Software Engineering or a related field (Master's or PhD… more