As part of an overall cross-functional Commissioning, Qualification and Validation (CQV) approach to equipment, cleaning and shipping validation, the Sr. Validation Specialist will be involved in all aspects of CQV within a US and EU GxP regulated environment.
Under the general guidance of the Validation Lead, the Sr Validation Specialist will independently manage the overall development and maintenance of GxP equipment and implementation and system lifecycle documentation. This includes: Validation Plans, User Requirements Specifications, Design Qualifications, Testing Protocols (IQ/OQ/PQ/DQ), Validation Summary Reports, Revalidation & Periodic Reviews, SOPs, Change Control Documentation and Risk assessments
• Lead planning, development, and implementation of manufacturing and lab equipment CQV documentation.
• Review/approve and execute the validation documentation for facilities, laboratory and support equipment, shipping, utility systems and process equipment including cleaning validation.
• Authors and interprets validation reports that reflect the validations performed with and without contractor support.
• Represent validation during the creation of Validation Strategy Documents and other project related documentation
• Initiate and participate as appropriate in associated change control requests, deviations, CAPAs and equipment acquisition documentation
• Responsible for all projects assigned. May act as an advisor to team members to meet schedules or resolve technical or operational problems. Directly participates in establishing and administering many centralized functional projects. Is cognizant of budgets, schedules, and performance standards in how they relate to work assigned.
• Works under consultative direction to perform corrective actions to address validation discrepancies and identified measurement problems. Work checked through consultation and agreement with others rather than by formal review of superior. Champion continuous improvements by developing best and proven practices in the department based upon current industry, US and EU guidelines.
• Oversight and co-management of Validation/CQV Service Providers
• Ensures schedules, and performance requirements are met
• Leads the development and maintenance of validation related Master Plans, SOPs, work instructions, and forms.
• Will represent function on specific projects, conduct briefings and technical meetings for internal and external representatives, as needed
Education and Experience Requirements
• BS degree in engineering or a life sciences field is required
• A preference of 7+ years of experience in validation within a GxP regulated environment (FDA, EU, MHRA)
• Experience working in a GMP environment is preferred.
• Experience developing full validation documentation and testing protocols (IQ/OQ/PQ/DQ) for manufacturing and laboratory equipment, Cleaning Validation for manufacturing equipment and cold chain shipping validation.
• Demonstrated working knowledge of Good Engineering Practices as they relate to equipment qualification
• Strong working knowledge of GxP compliance as well as USP, EP, ICH and FDA guidelines
• Six Sigma green belt or equivalent experience is highly desirable
Key Skills, Abilities, and Competencies
• Direct exposure and experience in a GxP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and how they relate to US and EU regulatory requirements and expectations
• Possess the ability to multitask and work independently or in a team environment with minimal supervision
• Possess good interpersonal and strong written/verbal communication skills
• Well developed skills in prioritizing, organization and time management
• Highly motivated and detail oriented with good organizational skills
• Ability to work in a dynamic, fast paced environment with shifting priorities
• “Hands-On” problem solving.
Complexity and Problem Solving
● Works on complex problems where analysis of situations or data requires evaluation of various factors including application of basic statistics. Exercises judgement within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Ensures budgets, schedules, and performance requirements are met.
● Builds productive relationships internally and externally.
● Frequent contacts with peers and vendors concerning projects, operational decisions, scheduling requirements, or contractual clarifications. Conducts briefings and technical meetings for internal and external representatives, as needed.
Internal and External Contacts
● Equipment end-users (owners) including Technical Operations/Manufacturing, R&D as well as corporate functions such as Corporate Facilities/IT, Finance, etc.
● Frequent external contacts, such as service providers, vendors and supplier representatives.
● Occasional contact with auditors and/or regulatory bodies
Other Job Requirements
● Limited travel requirements between Spark sites, as well as vendor/contractor visits, conferences/seminars, etc.
● Requirement to work some weekends and off-hours, depending on project schedules.
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
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