- 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
- Boehringer Ingelheim (St. Joseph, MO)
- …of validation of biopharmaceutical processes, equipment, utilities, facilities, cleaning validation , and USDA and FDA /EU regulations. + * Excellence in ... comprehension/application of USDA and FDA /EU regulatory requirements for validation /qualification of equipment/process/cleaning of regulated biological articles.… 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
- PCI Pharma Services (Madison, WI)
- …SKILLS** * Knowledge of Industry guidelines (ISPE, PDA), US and international regulations ( FDA , ICH, ISO, EMA) for validation of GMP facilities. * Possess ... to pioneer and shape the future of PCI. The Validation Engineer I performs an array of well-defined ...Validation Engineer I performs an array of well-defined validation activities in support of cGMP pharmaceutical/medical device contract… 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
- 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
- Kelly Services (Anasco, PR)
- …7 years of Project Validation related experience + Experience in validation process at manufacturing FDA regulated environment is required (data gathering, ... job that works for you. How about this one?** We're seeking **Project Validation Specialist (multiple positions) ** to work with one of out top… 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
- GNC (Greenville, SC)
- …Application Security, Data Security, Infrastructure Security, Software Security Practices, Compliance to FDA 's Computer Systems Validation Code (21 CFR Part 11), ... external stakeholders. + Subject Matter Expert in Good Manufacturing Practice Regulations, FDA Labeling regulations, CPSC and USDA regulations as applied to Foods… more
- Actalent (North Billerica, MA)
- …Skills + Quality assurance + CAPA + Investigation + Deviation + Trackwise + Audit + Validation + LIMS + FDA + CMO Work Environment The Director of Quality ... industry + Radiopharmaceutical experience a plus + Proficiency and knowledge of cGMPs, FDA , EMA, and ICH regulatory standards + Experience working with CMOs Job… more
- Globus Medical, Inc. (Audubon, PA)
- …idea/concept through design, prototyping, development testing, design verification and validation , manufacturing, FDA approvals, product introduction and ... 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
- Fujifilm (College Station, TX)
- **Overview** The Senior Validation Engineer, with minimal supervision, is a non-supervisory role and will be responsible for drafting Validation Project Plans ... (VPPs), System Impact Assessment (SIAs) and drafting and executing validation protocols for Facilities, Utilities, Systems and Equipment (FUSE), as well as preparing… more
- Fujifilm (College Station, TX)
- **Overview** The Validation Manager will be responsible for management, scheduling and/or hands on drafting and executing of qualification/requalification of ... of the 4 Manufacturing Buildings (NCTM, TBF-100, FBF-200, FBF-300). The Validation Manager will be responsible for updating the corresponding manufacturing… more
- Catalent Pharma Solutions (Harmans, MD)
- **Computer Systems Validation Engineer** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose ... is hiring an Engineer, CSV who is responsible for participating in validation projects related to manufacturing equipment, critical computer systems and laboratory… more
- Sokol Materials & Services (Skillman, NJ)
- CSV Validation Engineer Mid-Level Apply Now (https://forms.monday.com/forms/3cdf5bfb73703e4a3aa29c55653510f4?r=use1) Job Location Job Type Workspace Skillman, NJ ... Validation Engineer On-site position (no remote or hybrid options)...field (required). + Minimum of 5 years in an FDA -regulated industry, with at least 3 years in Computerized… more
- Unither Pharmaceuticals (Rochester, NY)
- Validation Technician Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify ... Your role Reporting to the Quality Director, JOB SUMMARY: Assists validation efforts in many ways including the following: executes/supports equipment, cleaning,… more