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Responsibilities:

• 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 system's 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 Company 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 Company's mRNA CoE owned equipment and
• systems.
• Help investigate and support management in all investigation (link removed)>
• Bachelor's (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.