- 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
- 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
- Regeneron Pharmaceuticals (Troy, NY)
- …and sterilization processes in Regeneron's Rensselaer facility. You will participate and defend validation data in FDA and other regulatory inspections. In this ... validation budget, contracts, and schedules. + Presenting/defending validation data to FDA and other regulatory agencies. + Maintaining validation … more
- Colgate-Palmolive (Piscataway, NJ)
- …to end system testing to evaluate functionality and performance + Handle and author FDA validation documentation ( Validation Plans, IQ, IQ, PQ protocols, ... business process and end users + Expertise in system design, testing, implementation, FDA validation and IT agile/waterfall methodology + Expertise in developing… 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
- Insight Global (Indianapolis, IN)
- …This engineer will go through a series of CQV (Commission, Qualification, Validation ) within an FDA regulated environment for a pharmaceutical customer. ... Job Description Insight Global is looking for a Validation Engineer to support a large HVAC customer.… more
- Envista Holdings Corporation (Pomona, CA)
- …functions. + Knowledge of FDA Medical Device Regulations + Knowledge of FDA process validation guidelines + Knowledge of Current Good Manufacturing Practices ... requirements and corporate standards. This involves assuring quality standards ( FDA , ISO, CMDCAS, MDD, MDR, MDSAP and Canadian Medical...assigned, in addition to those identified below + Ensures FDA QSR (GMP), FDA OTC, ISO 13485,… 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
- West Pharmaceutical Services (Scottsdale, AZ)
- …approval of resolutions + Keep current with all Industry standard practices and FDA requirements for validation , change control and complaint handling + Monitor ... planet through our sustainability efforts. **Job Summary:** Provide support for the validation program for the plant or assigned functional area regarding equipment,… more
- Charles River Laboratories (Ashland, OH)
- …+ Ensure methods from the method development are fit-for-purpose, and ready for FDA /EMA validation guidelines (where appropriate). + Ensure on-time and quality ... processes + Significant depth of knowledge in regulatory compliance ( FDA /EMA/EPA) as relates to bioanalytical sciences **PHYSICAL DEMANDS:** +...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… more
- WuXi AppTec (Cranbury, NJ)
- …in job offered. Require skills and knowledge inLC-MS/MS, HPLC/UPLC, Method Validation , BMV FDA guidance, Analyst software, GLP, Bioanalytical sampleanalysis. ... Plainsboro, NJ 08536. **Responsibilities** Lead in Method Development, Method Validation of bioanalytical methods, Bioanalytical sample analysis, calibration and… 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
- 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
- Boehringer Ingelheim (Athens, GA)
- …reflect Boehringer Ingelheim's high regard for our employees. The Principal Specialist, Validation manages all phases of higher level, more complex validation ... project activities at the BIAH location from concept through process validation ensuring GxP regulatory compliance continues as outlines in BIAH's Validation … more
- Actalent (Irvine, CA)
- …designs meet industry regulations and codes such as FAA, C Codes, ISO, and FDA . + Perform verification and validation of designs. Essential Skills + Proficient ... + Knowledge of industry regulations and codes (eg, FAA, C Codes, ISO, FDA ). + 3-5 years of experience in mechanical engineering. + Verification and … more
- Fujifilm (College Station, TX)
- …hub of innovation, representing a source of pride for the area. The Validation Manager will be responsible for management, scheduling and/or hands on drafting and ... of the 4 Manufacturing Buildings (NCTM, TBF-100, FBF-200, FBF-300). The Validation Manager will be responsible for updating the corresponding manufacturing… more
- Eastman (Kingsport, TN)
- …visit www.eastman.com. Role Profile Under minimal supervision, the Global Quality Validation Representative based in Kingsport, TN, will take charge of managing ... across their lifecycle, ensuring adherence to regulatory standards, Computer Systems Validation (CSV), and Data Integrity requirements. They will oversee … more
- embecta (Holdrege, NE)
- …support the varying needs of our diverse and global employees. The Site Validation Engineer is responsible for execution and implementation of validation ... in support of product design activities and maintenance of the site validation process. Additional responsibilities include cross functional support for the Quality… more
- ThermoFisher Scientific (Greenville, NC)
- …understanding of validation principles, including equipment, process, and computer system validation . * Detailed knowledge of cGMP, FDA , EMA, ISO, and other ... Standards, Office **Job Description** **Job Summary:** The Senior Manager of QA Validation will provide oversight and manage the validation activities across… more
- Catalent Pharma Solutions (Harmans, MD)
- **Senior Engineer, Computer Systems Validation ** **Position Summary:** Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical ... a Senior Engineer, CSV who is responsible for participating in validation projects related to manufacturing equipment, critical computer systems and laboratory… more