- Bristol Myers Squibb (Summit, NJ)
- …technical SME network. + Serve as global consultant for update and revision of exiting site validation master plans. + Develop and guide process validation , ... the Global Technical SME for Drug Product and Vector Validation . The lead will develop global technical... will develop global technical standards for cell therapy validation and deploy the standards to site … more
- Teva Pharmaceuticals (West Chester, PA)
- …improvements, and the revalidation program. + Responsible for the preparation of site validation documentation (ie qualification protocols, validation master ... standards and procedures, and implementing industry best practices. The Validation Engineer III will lead , organize, and...Plans, Cleaning Validation Plans, and Computer Systems Validation Plans. 100% ON- SITE IN WEST CHESTER,… more
- ThermoFisher Scientific (Middletown, VA)
- …**is responsible for assisting the validation team in supporting all site validation activities. This includes automation equipment, product transfers, new ... **Assist the validation team in maintaining the Site Validation Master Plan.** **Support development projects,...associated data in accordance with FDA and ISO requirements.** ** Lead and/or assist in training of staff involved in… more
- ThermoFisher Scientific (Middletown, VA)
- …for leading / assisting the validation team in supporting all site validation activities. This includes automation equipment, product transfers, new product ... **Assist the validation team in maintaining the Site Validation Master Plan.** + **Support development...data in accordance with FDA and ISO requirements.** + ** Lead and/or assist in training of staff involved in… more
- Kelly Services (Middletown, VA)
- …for leading / assisting the validation team in supporting all site validation activities. This includes automation equipment, product transfers, new product ... Assist the validation team in maintaining the Site Validation Master Plan. * Support development...data in accordance with FDA and ISO requirements. * Lead and/or assist in training of staff involved in… more
- CGI Technologies and Solutions, Inc. (Plymouth Meeting, PA)
- …and labs teams from management downstream to hyper care support teams * Manage and lead all site validation activities along with the calibration and ... **Lab Equipment Validation SME** **Category:** Testing/Quality Assurance **Main location:** United...with system configuration and changes as directed by Client Lead and document results/procedure to configure * Demonstrates facility… more
- Amazon (Westborough, MA)
- …commissioning and validation activities. * Availability to travel up to 75% for on- site validation and commissioning tasks. A day in the life Amazon offers a ... of a technical team, with the following responsibilities: Key job responsibilities * Lead Commissioning and Validation (C&V) initiatives for new robotic systems… more
- Bristol Myers Squibb (Bothell, WA)
- …system as part of the Agile methodology. + Support GMSAT including our R&D site to execute validation related projects and make standardization across the sites. ... Read more: careers.bms.com/working-with-us . **Position Summary** The Senior Manager, Validation , Engineering and Technology is responsible for supporting the… more
- ThermoFisher Scientific (Lebanon, TN)
- …Performance Qualification (PQ). **Responsibilities Include:** + Development and maintenance of Master Validation Master Plan for site + Participate in technical ... discrepancy management, and project close-out. This role will also lead CAPA investigations for internal quality issues and customer...aspects of equipment and software validation at the site , including Equipment Qualifications… more
- Takeda Pharmaceuticals (Social Circle, GA)
- …of automation platforms, such as DeltaV, Honeywell, Rockwell PLC, Siemens XFP. + Lead validation projects, coordinate contractors, and improve results. + Direct ... is true to the best of my knowledge. **Job Description** You will support site projects, technical transfers, and ongoing validation maintenance on- site at… more
- CSL Behring (Kankakee, IL)
- …CSL Enterprise global manufacturing sites. + Provide strategic leadership to the site engineering, validation , operations, and quality functions related to ... and evaluate the divisional objectives. + Together with regional lead , site head and site ...the required standards and regulatory requirements with respect to validation activities affecting sterile manufacturing (Fill / Finish area… more
- Gilead Sciences, Inc. (Frederick, MD)
- …+ Support the change control process for validated systems. + Support the site validation team. + Support the cross-functional system owners with strategic ... **Responsibilities:** + Provide Quality Engineering oversight for Commissioning, Qualification, and Validation (CQV) related activities. + Represent site in… more
- Unither Pharmaceuticals (Rochester, NY)
- …finished product test methods and specifications etc. Provides Quality oversight to the validation maintenance of the site , including review and approval of ... Quality Specialist - Development & Validation Who we are? We are a French...of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on… more
- Unither Pharmaceuticals (Rochester, NY)
- …processing, and packaging equipment and facilities supporting these operations. Ensures appropriate validation activities are included in site or team project ... Validation Specialist Who we are? We are a French...of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4… more
- Takeda Pharmaceuticals (Boston, MA)
- …requalification of GxP manufacturing equipment used for commercial production, including developing validation strategy to the site and global projects. You will ... the manufacturing facility by building partnerships across departments. + Lead and represent the respective validation elements...departments. + Lead and represent the respective validation elements to determine validation strategy and… more
- Takeda Pharmaceuticals (Social Circle, GA)
- …of automation platforms, such as DeltaV, Honeywell, Rockwell PLC, Siemens XFP. + Lead validation projects, coordinate contractors, and increase results. + Direct ... of my knowledge. **Job Description** **About the role:** You will support site projects, technical transfers, and ongoing validation maintenance. Responsible for… more
- Merck (West Point, PA)
- …reviewing various sending (control strategy, comparability strategy etc.), and receiving site documents ( validation protocols, Batch Reports, campaign summary ... highly motivated individual for the role of Associate Director, Tech Transfer Leader in Large Molecule Technology Transfer within Technical Product Leadership. This… more
- Lilly (Lebanon, IN)
- …with corporate standards; consultation and interpretation on applying and right-sizing validation requirements; maintaining corporate and site computer systems ... and paper), the application of data management/integrity principles in the site 's processes, and validation /maintenance requirements to support regulatory… more
- Endo International (Rochester, MI)
- …quality, engineering, and manufacturing operations functions ensure all quality aspects of validation and qualification activities at the site including process ... and manufacturing operations functions to ensure the quality aspects of validation and qualification activities, performing various types of analysis and generating… more
- Surgery Care Affiliates (New Albany, IN)
- …use of personal protective equipment. + Complying with Universal Protocol and facility site validation and time-out policy + Communicating the patient's current ... support growth and transition to value-based care. + We lead the industry in value-based payment solutions through our...aseptic technique. + Complying with Universal Protocol and facility site validation and time-out policy. + Maintain… more