- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Validation Specialist I as part of the Quality team based in Raritan, ... NJ. Role OverviewThe QA Validation Specialist role is an exempt level...and qualification activities for equipment, systems , computer systems , and processes within a cell therapy manufacturing… more
- Merck & Co. (Durham, NC)
- …Position Description: Durham-Technology consists of the Automation/MES, Deviation Management, Manufacturing Technical Operations, Validation , and New Product ... Job DescriptionOur Engineers support internal manufacturing operations to ensure they remain operational, and continuously improve and innovate. With our extensive… more
- Merck & Co. (Rahway, NJ)
- …Define and implement data standardization rules and practices across multiple source systems . Support the extraction, transformation, and validation of process ... Job Description Position Description: Digital Chemistry, Manufacturing , and Controls (dCMC) is a cross-divisional digital...to create a frictionless flow of data from source systems to regulatory documentation.- Under the guidance of dCMC… more
- AbbVie (North Chicago, IL)
- …Pharmaceutical experience strongly preferred. + 6+ years of overall experience in Manufacturing , Quality or Engineering including 4 major validation subjects (eg ... to plan, and complete tasks associated with commissioning, qualification and validation of new and modified equipment, facilities, utilities, product, processes… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that ... Functional and Design Specifications. If completed by an external company, the computer systems validation (CSV) specialist will be responsible for obtaining… more
- Catalent Pharma Solutions (Winchester, KY)
- …commercial manufacturing , and roots in industry-leading Glatt technology. The Validation Specialist provides support and oversite of Process/Cleaning ... ** Validation Specialist ** **Position Summary** Catalent, Inc....Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture,… more
- Catalent Pharma Solutions (Kansas City, MO)
- **Senior Validation Specialist I, BioAnalytics Computer System Validation (CSV) & Compliance** **Position Summary:** Catalent, Inc. is a leading global ... in Kansas City, MO (KCM) is hiring a Senior Validation Specialist I, BioAnalytics CSV & Compliance....- Electronic Records, Electronic Signatures, EudraLex, Volume 4, Good Manufacturing Practices, Annex 11 Computerized Systems ) +… more
- Reckitt (Wilson, NC)
- … Validation Specialist is responsible for executing and supporting validation activities across computerized systems , manufacturing processes, and ... Validation Specialist City: Wilson **We are...**Your responsibilities** + Support validation of GxP-regulated systems (LIMS, MES, ERP) and equipment ( manufacturing ,… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- **Senior Validation Specialist ** **Position Summary** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose ... Catalent network, we offer a broad range of integrated formulation. The **Senior Validation Specialist ** with guidance from the Validation Manager, defines… more
- United Therapeutics (Silver Spring, MD)
- …playing a key role in ensuring the compliance and performance of critical manufacturing systems -including QC lab equipment, and upstream, downstream, and aseptic ... your expertise in a dynamic biotech and pharmaceutical environment? As a Senior Validation Engineer or Specialist , Equipment, you'll be a subject matter expert… more
- Boehringer Ingelheim (Athens, GA)
- …programs reflect Boehringer Ingelheim's high regard for our employees. The Principal Specialist , Validation manages all phases of higher level, more complex ... and requirements and are suitable for their intended purposes. The Principal Specialist , Validation will lead project management efforts for validation… more
- Lotte Biologics USA LLC (Syracuse, NY)
- …to reliably deliver benefits for patients worldwide. Position Summary As a Senior Specialist , Validation Services, you will play a key role in supporting ... test plans, and regulatory guidelines. + Proficiency in troubleshooting equipment and systems during validation activities. + Ability to manage multiple… more
- Bausch + Lomb (Tampa, FL)
- …validation of the following validation elements: manufacturing / packaging equipment, facilities, utilities, computerized systems , temperature-controlled ... Validation experience. + Experience in any of following types of validation is desired: utilities, facilities, manufacturing equipment (compounding, filling,… more
- Astellas Pharma (Sanford, NC)
- ** Specialist , QA Validation ** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to ... on Astellas, please visit our website at **www.astellas.com** . **The Role** The Specialist , QA Validation will be primarily responsible for the implementation,… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …QA Validation team is hiring. As the Senior QA Validation Specialist , you will ensure equipment, systems , and processes meet regulatory standards while ... adhering to company manufacturing policies and procedures. This role will support our...the following years experience for each level: + QA Validation Specialist : 2+ years + Sr QA… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- We are seeking a highly skilled, self-motivated **Senior Validation Specialist - CSV** to ensure compliance of computerized systems with regulatory ... 11, GAMP 5, and Annex 11. **As a Senior Validation Specialist , a typical day might include:**...experience. Must have experience in a pharmaceutical or biopharmaceutical manufacturing facility; GMP experience is required. Experience with ERP,… more
- Biomat USA, Inc. (Research Triangle Park, NC)
- …Hybrid position based out of our RTP, NC Office.** Ensures current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems are adhered to throughout ... in the development of cGMP operating procedures that relate to process, computer systems , and equipment validation . + Assures compliance with SOPs upon… more
- Quality Consulting Group (Villalba, PR)
- …with 0 years of experience + Practical knowledge and demonstrated competence in validation and quality systems + Investigation and root cause analysis skills ... CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic… more
- Bristol Myers Squibb (Summit, NJ)
- …no better place than here at BMS with our Cell Therapy team. The MS&T Manufacturing Systems Engineering and Operations - Manufacturing Systems Engineer ... Teams. Works under the guidance of lead team members. Manufacturing Systems Engineers primarily work with local...minimum of 3 years of EMES system (or equivalent systems ) validation (backend validation , UAT,… more
- Mentor Technical Group (Caguas, PR)
- …Collaborate with cross-functional teams to integrate and optimize: + Material cleaning systems + Collaborative robots (eg, automated palletizers) + EFD lubrication ... systems + Cognex vision systems for inspection...related field. + 2+ years of experience in equipment validation or automation in a regulated industry. + Familiarity… more
