| Hiring for Validation Specialist - Waltham, MA at Waltham, Massachusetts, USA |
| Email: [email protected] |
| From: Arvind kumar, Sibitalent.com [email protected] Reply to: [email protected] Hi Hope you are doing well, I came across your profile from Job portal/Employer and wanted to reach out regarding a unique opportunity. I work for Sibitalent Corp and were looking to hire a Validation Specialist. I think your experience in Field/Skill is a great fit for this role. Please find the Job details below kindly revert if youre interested in learning more about this job. Tax term C2C/W2 Title : Validation Specialist Location : Waltham, MA Duration : 6+ Month Experience : 3+ The position has the possibility for conversion Free Parking at this site The manager is open to candidates willing to relocate at their own expense. Role will: provide quality/ QAV services, review and approve protocols, pre-execution review, post-execution reviews. Quality is a must-have in this role, there is no separate quality team in this department 60% review and approval protocols 40% support on the execution activities Must Have: Min 1-year min QAV (Quality Validation) Experience Qualification activities Strong Experience with Documentation &SOPs Previous experience reviewing and approving protocols Previous QAV role, pre-execution review and post-execution review Experience qualifying equipment categories, Laboratory equipment, computer systems validation equipment, CMMS Nice to Have: 3 years of Quality Validation Experience Experience working with Vendors Support Sanofis mRNA CoE Validation department. Field support of the FTE and consultant activities in the Commissioning, Validation and Maintenance phases of the Validation Lifecycle of the relevant Facilities, Utilities, Systems and Equipment. Author the necessary Validation Protocols and Project Plans, and support all field activities performed in support of their execution. Help drive on time deliverables in a compliant manner, while serving as the Validation Subject Matter Expert and interacting with customers on their needs. Serve as liaison and cross-functional lead with Engineering, Manufacturing and Quality Assurance to provide an overall compliant program with industry standards and GMP regulations. Help review proposed changes to validated systems and identify the validation requirements necessary to maintain the systems validation status after execution of the change. Help enforce compliance to senior leadership strategy and direction, as it pertains to the areas of cleaning validation, equipment validation, computer systems validation and routine maintenance of validated systems. Support the phase appropriate strategy to the validation deliverables for new and existing facilities and labs. Support the site-wide calibration and maintenance program for all Sanofi mRNA CoE owned GxP equipment and systems. Support the planning, scheduling and completion of all Metrology work performed to ensure timely maintenance and calibration activities on Sanofis mRNA CoE owned equipment and systems. Help investigate and support management in all investigation Bachelors (or post-graduate degree) in a relevant field to the biotech or pharmaceutical industry. Must have 3+ years of experience within a Validation organization in the pharmaceutical, biologics or medical device industries. Must have 3+ years of experience in working with facility start-ups, factory/ site acceptance testing, commissioning/Qualification activities and all associated supporting documentation generated during the course of these activities. Experience with continuous improvement of Validation operations in response to business needs and customer audits/regulatory inspections. Experience in execution of field activities associated with validation protocols, project plans, data analysis, a compilation of data into final reports and project summary/close out. Experience in asset management and in NIST traceability to standards. Demonstrated experience in working in compliance with US, EU and ICH GMP requirements. Preferable experience in early-phase clinical efforts, which are not under the stringent requirements of a commercial facility. Preferable experience in supporting a Phase I/II company up through commercialization. Excellent oral and written communication skills. Strong interpersonal skills to effectively manage teams, communicate with peers, management and external contacts. Thanks & Regards Arvind Kumar Technical Recruiter LinkedIn || Direct : +19368737096 E-Mail: [email protected] Website: www.sibitalent.com Office : 118 Carolynn Lane Murphy, TX 75094 Keywords: information technology wtwo Massachusetts Texas |
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| Sun Jun 25 02:57:00 UTC 2023 |