Experience in medical device manufacturing, Bio/pharma is also good. Develop and implement processes to support the production of Orthopedic implants. Experience with metal finishing processes preferred. Experience with Change Control Validation in a regulated environment (medical device). IQ/OQ/PQ Experience. Equipment Validation/Machine Validation Experience. Experience in technical writing. Experience with Data and statistical analysis. Writin...
Position Summary. Responsible for all aspects of the validation process, including: documenting commissioning activities. establishing the process and equipment acceptance criteria. and developing and performing qualification studies to document evidence which provides a high degree of assurance that equipment and processes (including cleaning processes) will consistently produce a product meeting its predetermined specifications and quality attr...
Job Details. Required Citizenship / Work Permit / Visa Status*: /H1B Transfer/Canadian Citizens (TN VISA)/OPT EAD. Position Summary. Responsible for all aspects of the validation process, including: documenting commissioning activities. establishing the process and equipment acceptance criteria. and developing and performing qualification studies to document evidence which provides a high degree of assurance that equipment and processes (includin...
Validation Engineer. Only candidate with minimum of 3 years pharmaceutical industry. Reports To: Work Location: Decatur, Illinois, USA. Employer is able to sponsor TN visa for Canadian candidate willing to move to US. Position Summary. Responsible for all aspects of the validation process, including: documenting commissioning activities. establishing the process and equipment acceptance criteria. and developing and performing qualification studie...
Position: Validation Engineer. Location: Raynham MA. Rate: 30-35$ Per Hr. Job Description / Requirements. A minimum of a Bachelor's degree in Engineering is required, manager likes candidates with Biomedical Engineering Degrees. Minimum of 0-2 years experience in medical device manufacturing, Bio/pharma is also good. Develop and implement processes to support the production of Orthopedic implants. Experience With Metal Finishing Processes Preferr...
Schedules and executes equipment requalifications per Standard Operating Procedures (SOPs). Coordinates and communicates all testing with affected functional groups and evaluates test results. Analyzes data, composes a final report and circulates for approval. Executes equipment validation studies to include protocol preparation, scheduling, protocol execution, and final report preparation. Participates in presentation of results to Regulatory Ag...
Hybrid Role. Support timely review of all GMP documents (batch records/analytical specifications, data, validation protocols/reports, COAs, deviations, change controls, etc.) and ensure alignment with quality and regulatory expectations prior to release and/or approval. Maintain organization of project deliverables for external partner project using applicable tools. Identify and communicate quality risks in a pro-active and collaborative manner ...
Roles & Responsibilities. Bachelor's/ master's degree or equivalent in a scientific or health care field. 8-10 years of experience as a Senior Validation Analyst/ Lead preferably in the pharmaceutical /Life sciences industry preferred. Support life cycle documents and execution. Management and support of change controls necessary for the projects and its lifecycle through process Compliance and interface with Quality Assurance change control area...
Join a Market Leader. Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market. . Our people are the main asset for our...
Configuration Manager III. Fort Meade, MD. . We’re seeking a Configuration Manager to support our U.S. Government program(s). The Configuration Manager will be responsible for. configuration management (CM) of developmental and operational systems. . . Works on developmental and operational teams to create and maintain configuration baselines (development, test, production, etc.) supporting developmental and operational systems. . Uses or recomme...
Responsibilities: Provide FDA validation experience and guidance during equipment design, software design, build, debug, and qualification phases of a project. Write overall project quality (validation scope) plans. Organize, guide, and write requirement specifications as necessary. Review qualification/requalification packages for completeness and accuracy, sound rationale, compliance with validation policies. Interface with internal and client ...
. ABOUT SANISURE. SaniSure is a multinational manufacturer of single-use bioprocessing solutions (SUT) used in the production of biological drugs, including monoclonal antibodies, cell therapies, gene therapies, and vaccines. With operations in the U.S. and in Europe, SaniSure operates a leading platform of vertically integrated critical fluid management technologies and integrated solutions. Its single-use products and system solutions are sold ...
