- Oberg Industries (Sarver, PA)
- …preferred. + Internal auditing/supplier auditing experience preferred. + Working knowledge of FDA 's Process Validation requirements and methods, (IQ, OQ, PQ) + ... Are you ready to take your validation engineering skills to the next level? Join...devices. This role ensures compliance with regulatory requirements (eg, FDA , ISO 13485, ISO 9001, and AS9100) and internal… more
- PCI Pharma Services (Philadelphia, PA)
- …sterilization process. This includes strong working knowledge of ISO 14937, ISO 11135, FDA Process Validation Guidance, and EMA Annex 15, Qualification, ... regulated industries. + Strong working knowledge of ISO 14937, ISO 11135, FDA Process Validation Guidance, and EMA Annex 15, Qualification and Validation … more
- Catalent Pharma Solutions (Bloomington, IN)
- …meet the quality standards and requirements of company policies and FDA regulations. **The Process Validation Manager's responsibilities include managing ... to our mission: to help people live better, healthier lives. The Validation strategy is to manage projects relating to biopharmaceutical manufacturing equipment,… more
- BioFire Diagnostics, LLC. (Hazelwood, MO)
- …large groups is highly preferred. + Must possess thorough understanding of cGMPs, FDA validation requirements, ISO and MDSAP standards and regulations. + ... quality systems and approaches. Lead team of quality engineers and validation engineers to provide guidance for investigations, recommend solutions using risk… more
- Bristol Myers Squibb (Devens, MA)
- …biologics / cell therapy manufacturing facility. + Highly knowledgeable of regulatory validation requirements including FDA , EMA and all other Worldwide ... their personal lives. Read more: careers.bms.com/working-with-us . The Manager, Sr. Validation Engineer I supports the successful implementation of manufacturing and… more
- Bristol Myers Squibb (Devens, MA)
- …to work and manage within a regulatory environment. + Knowledge of regulatory validation requirements including FDA , EMA and all other Worldwide Regulatory ... personal lives. Read more: careers.bms.com/working-with-us . **Position:** Manager, Cleaning Validation , Validation Engineering **Location** : Devens, MA… more
- Reynolds American (Winston Salem, NC)
- …deliver validation training + Provide metrics for business reporting + Serve as validation project SME during FDA inspections and Serve as the back-up ... validation SME to present validation framework during FDA inspections **What are we looking for?** + Bachelor of Science degree or validated experience +… more
- PCI Pharma Services (Bedford, NH)
- …SKILLS** * Knowledge of Industry guidelines (ISPE, PDA), US and international regulations ( FDA , ICH, ISO, EMA) for validation of GMP fill finish facilities. ... PCI. **JOB SUMMARY** Reporting to the Senior Manager process Validation , the Process Validation Engineer III/IV is accountable for guiding teams and performing… more
- Colgate-Palmolive (Piscataway, NJ)
- …from team into clear IT deliverables to build a successful system** + **Write FDA validation documentation ( Validation Plans, IQ, IQ, PQ protocols, write ... in conditions can affect outcomes** + **Expertise in system design, testing, implementation, FDA validation and GIT's 5 step methodology** + **Expertise in… more
- Verista (New Brunswick, NJ)
- …to align validation activities with construction schedules. + Ensure all validation documentation complies with regulatory standards ( FDA , cGMP). + ... + Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as… more
- Takeda Pharmaceuticals (Lexington, MA)
- …solutions (eg Syncade, Rockwell, ProPack Data, Werum PAS-X). + Knowledgeable in FDA validation requirements preferred, including: User Requirement and Design ... Process Engineering, Quality, Manufacturing Sciences and others. + Integrate the Validation and Quality department requirements into the daily routine. + Network… more
- West Pharmaceutical Services (Tempe, AZ)
- …approval of resolutions. + Keep current with all Industry standard practices and FDA requirements for validation , change control and complaint handling. + ... planet through our sustainability efforts. **Job Summary:** Provide support for the validation program for the plant or assigned functional area regarding equipment,… more
- Reynolds American (Winston Salem, NC)
- …Relationships:** + Business Controls & Processes group + Internal Audit group + FDA Validation group + Various Digital Business Solutions teams and departments ... as needed + Global Services Teams **Geographic Scope:** Local **Travel Required:** Less than 10%. **WHAT YOU WILL BE ACCOUNTABLE FOR** + Responsible for IT Logical Security processes for Joiners, Movers and Leavers (JML), SSO solutions, and SOX Processes… more
- Actalent (Miramar, FL)
- …training materials, and SOPs. Skills: process development, capex, equipment selection, validation , FDA , cGMP Qualifications: Process Development Capex Equipment ... criteria, safety standards, budgets, and timelines are met. + Develop validation master plans and protocols (IQ/OQ/PQ) for equipment, facilities, systems, cleaning,… more
- Kelly Services (Gurnee, IL)
- … validation documents and SOPs. **Skills:** + Strong understanding of GMP, FDA regulations, and method validation principles. + Excellent written and verbal ... DOE **Objective:** To draft necessary documentation and procedures supporting the validation process, perform method validation , and author validation… more
- Actalent (Torrington, CT)
- …in the absence of the QA Director. Hard Skills + IQ, OQ, PQ ( FDA Regulations)/ Validation + AS 9100 + Metrology Experience Preferred + Working knowledge ... of MS Office programs (Word, Excel, PowerPoint, Outlook) Soft Skills + Ability to work with minimal supervision + Strong problem-solving skills + Effective communication skills + Ability to work cooperatively with others in stressful situations. Work Site This… more
- System One (Easton, PA)
- …life science experience and understanding of regulatory requirements, specifically with FDA system validation . + Professional security management certification ... such as CISM, CISSP, or CISA is highly desired. + Strong understanding of cybersecurity principles, practices, technologies, and emerging trends. + Proven track record of developing and implementing effective cybersecurity strategies and programs. + Excellent… more
- Teleflex (Mansfield, MA)
- …files. * Experienced in Software as a Medical Device (SaMD) and software validation . * Working knowledge of US FDA quality system regulations, ISO ... * Ability to support 510(k) and other applications at CDRH/ FDA . * Ability to evaluate validation packages...applications at CDRH/ FDA . * Ability to evaluate validation packages for compliance to applicable regulations and standards.… more
- Kelly Services (Carlsbad, CA)
- …life science setting. + 3+ years of IT QA experience with regards to IT validation and FDA regulations + **Highly desirable skill includes IT QA experience ... Systems), SDLC (Software Development Lifecycle) and Regulated IT system/software validation , overseeing compliance and quality management for IT systems/software. +… more
- Globus Medical, Inc. (Audubon, PA)
- …idea/concept through design, prototyping, development testing, design verification and validation , manufacturing, FDA approvals, product introduction and post ... specifications for new product development + Creates and maintains project plans and FDA complaint Design history Files (DHF) for each project + Manages all aspects… more