- Aequor (Swiftwater, MN)
- …the ability to defend rationale in validation documents. o Ability to develop cleaning cycle and lead the investigation or trouble shooting. o Ability to ... THIS IS A CLEANING VALIDATION POSITION. Duties Experience in cleaning validation in the biologics or vaccine industry to include the following: o… more
- Merck & Co. (Durham, NC)
- …Specialist, Quality Control participates in a team of analysts in the development, validation , and routine testing of the vaccine product. The position will focus on ... for commercial production.- The selected candidate will participate in equipment validation , process validation , and GMP laboratory readiness.- The Quality… more
- Novo Nordisk Inc. (Durham, NC)
- …support is on site as needed during production activities Coordinate all validation /transfer activities involving MDev support Lead team in successful execution ... applications of cGMP's is required Demonstrated knowledge of pharmaceutical industry validation requirements including a thorough understanding of cleaning ,… more
- Merck & Co. (Rahway, NJ)
- …forums.Under the guidance of more senior staff, may serve as the data management lead or perform a support role for filing programs. Participates in the development ... not limited to: 1. Develops detailed project plans for the collection, review, and cleaning of all clinical data for assigned trials within a specific drug / vaccine… more
- Catalent (San Diego, CA)
- …client QA counterparts. Site Recall/Quality alert program, Facility/equipment/process/analysis method/ cleaning validation and qualification program.Other duties ... direct experience and working knowledge of validation principles, including validation of processes, equipment, systems, analytical methods, cleaning , and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trials, clinical development, and regulatory submissions. The position will perform validation of the electronically transmitted external data by ensuring all ... Clinical Biomarkers, QCP, etc.) for establishing data collection, data standards and data cleaning needs for DS Programs / Studies.Serve as the subject matter expert… more
- Russell Tobin & Associates (Oceanside, CA)
- …orders, SOP changes,- Review Planned/Unplanned events and provide initial assessment for validation lead . Requirements:- 5 -7 years of relevant validation ... our Life Science client based out of Oceanside, CA 92056 Responsibilities:- Lead or support cleaning , equipment, utilities, sterilization and/or autoclave… more
- Catalent (San Diego, CA)
- …and small molecule API, intermediates, and drug products from scratch.Develop cleaning verification methodsPerform and train others on a variety of analytical ... externally through oral and written updates and formal reports as necessary. Lead discussions with clients on technical topics relating to their project. Supervisor… more
- bioMerieux (Efland, NC)
- …be 7:00am - 7:30pm working a 2-2-3 schedule The Line 4 Technical Lead position is responsible for front line troubleshooting, process improvement oversight / ... cGMP compliant manner. Primary Responsibilities: Production:As on shift Tech Lead , responsible for front line troubleshooting of high-speed equipmentIdentify,… more
- eXcell (Seattle, WA)
- …and advise on best practices for model identification in coordination with the Lead Data Scientist Collaborate with data stewards, system subject matter experts, and ... learning models including feature engineering and hyperparameter tuning Collaborate with Lead Data Scientist to ensure the model meets original objectives and… more
- Alpha Baking (Chicago, IL)
- …cross functional departmental meetings to review recommendation, findings, and progress. Lead in partnership with other Quality Managers the development and ... Oversee the sanitation departments to ensure master sanitation schedule, daily cleaning schedule, and chemical control programs are being followed. Perform food… more
- MannKind Corporation (Danbury, CT)
- …product, and stability samples, complaint samples, samples from process and cleaning validation activities Exercise judgment within defined procedures and ... action. Critically review data for anomalies or trends and approve data Lead and approve investigations of suspect or out of specification results. Ensures… more
- BeiGene (Hopewell, NJ)
- …SOP's, Comparability Reports, Aseptic Process Simulation Protocols and Reports, Cleaning Validation , Process Validation (PPQ). + Lead validation ... as a point of contact with different business areas, lead and handle validation projects, ensure the...aseptic processing knowledge required. + Knowledgeable in Computerized System Validation (CSV), Cleaning Validation , Process … more
- Lilly (Concord, NC)
- …and technical organization from the ground up. The Principal Scientist/Engineer - Cleaning Validation /Sterilization Validation - Technical Services / ... and implementation of validation strategies, including sterilization validation , cleaning validation , filter .... Provide technical guidance to the Process Team for cleaning and sterilization processes. . Lead or… more
- VTI Life Sciences (San Diego, CA)
- …We are looking to staff a Validation Engineer with strong experience in cleaning validation and temperature mapping for a 9+ month project with our ... assignments. + Provide swab, rinse and visual inspection for cleaning validation sampling + Perform temperature mapping...+ Review planned/unplanned events and provide initial assessment for validation lead . + Review of lifecycle documents… more
- Takeda Pharmaceuticals (Social Circle, GA)
- …automation qualification with Honeywell, Delta V, and PCL-based systems + Computerized systems validation + Cleaning validation + Sterilization validation ... platforms, such as DeltaV, Honeywell, Rockwell PLC, Siemens XFP. + Lead validation projects, coordinate contractors, and improve results. + Direct experience… more
- Takeda Pharmaceuticals (Boston, MA)
- …meet demands in the manufacturing facility by building partnerships across departments. + Lead and represent the respective validation elements to determine ... such as (21 CFR Parts 210, 211, 600, ISO 14644, EC-Annex1). + Plan, and schedule validation assignments and lead the validation team to prepare protocols and… more
- ICU Medical (Dublin, OH)
- …For Process and Cleaning : Technical Transfers of products . Execution of validation documents to support company goals . Development of validation procedures ... and validation gap analysis as required. . Plan and lead revalidation of existing plant equipment (including sterilization equipment), facilities, utilities,… more
- ThermoFisher Scientific (Middletown, VA)
- …prioritization changes in a fast-paced environment.** + **Strong understanding and proficiency in cleaning validation and cleaning process design.** + **Must ... is safe or helping find cures for cancer.** **The Validation Staff Engineer is responsible for leading / assisting...data in accordance with FDA and ISO requirements.** + ** Lead and/or assist in training of staff involved in… more
- ThermoFisher Scientific (Middletown, VA)
- …validation principles and regulatory requirements.** **Strong understanding and proficiency in cleaning validation and cleaning process design.** **Must ... or helping find cures for cancer.** **The** **Engineer III, Validation ** **is responsible for assisting the validation ...associated data in accordance with FDA and ISO requirements.** ** Lead and/or assist in training of staff involved in… more
