Senior Validation Specialist I, BioAnalytics CSV & Compliance

Catalent-posted 10 days ago
Full-time • Mid Level
Onsite • Kansas City, MO
5,001-10,000 employees
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Senior Validation Specialist I, BioAnalytics Computer System Validation (CSV) & Compliance Position Summary: Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent’s Kansas City facility is home to our Clinical Delivery Services and Biologics Analytical Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects. Catalent Pharma Solutions in Kansas City, MO (KCM) is hiring a Senior Validation Specialist I, BioAnalytics CSV & Compliance. The Senior Validation Specialist is primarily responsible for leading, implementing and managing Computer System Validation (CSV) and Data Integrity Programs (DI), projects and all associated expectations and activities at the BioAnalytics site. This person is also responsible for drafting, reviewing, and approving technical documents such as Standard Operating Procedures (SOPs), validation protocols, risk assessments, Change Controls and Deviations in a Good Manufacturing Practices (GMP) environment. This is a full-time on-site salaried position: Monday – Friday on 1st shift. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

  • Will lead all aspects of CSV program including ownership of project Objectives, Timelines, Resources, Cost and Quality from small to large site-level technology program rollouts for the site
  • Work with external technology vendors, internal support groups (local IT, global-corporate IT, Validation, QA) and internal Business Units (Manufacturing, Pharmaceutics, Analytics, Quality Control) to successfully manage all assigned CSV program deliverables
  • Successful application of solid Project Management skills in procurement, integration, and implementation of new and upgrades of laboratory software, instruments, applications, and information systems
  • Author, review and approve CSV, DI and Validation related documents and provide input and guidance to Site Leadership as KCM’s CSV & DI Subject Matter Expert (SME). Ensure all CSV deliverables driven by System, Software, User Functionality and Safety Requirements are developed, executed, and documented per KCM SOPs, Corporate Policies and Regulatory guidelines
  • Represent KCM BioAnalytics as the CSV and DI SME in Regulatory, Client and Internal Catalent audits. Follow cGMP requirements for legible, accurate and thorough documentation to meet regulatory compliance.
  • Mentor junior colleagues in good documentation practices (GDP)
  • Research and write general Periodic Reviews/Data Integrity Reviews for all qualified items including equipment, instruments, and software systems, as applicable. Perform support compliance activities such as risk assessments, data integrity effects, etc.
  • Author deviations as a lead investigator for the analytical department and drive them to completion.
  • Support Validation Management in ensure all CSV activities meet Scope, Schedule, Budget, and Quality requirements; including participation in budget reviews and other financial programs, as directed
  • Participate, support, and drive Continuous Improvement initiatives. Assist in Change Management, CAPA, and Deviations.
  • Perform and co-ordinate peer review of validation protocols, and risk assessments
  • All other duties as assigned
  • Requires a Bachelor’s Degree minimum in a Scientific field with at least six years of relevant experience. We will also accept a Master’s Degree with four years of experience OR a PhD with at least three years of relevant experience
  • Must demonstrate knowledge of CSV, Validation, Quality, IT and Regulatory Compliance. Familiarity with cGMPs, ISPE GAMP5, fundamental validation practices and the following FDA and European Commission Regulations (such as: 21CFR 211 Current Good Manufacturing Practice for Finished Pharmaceuticals, 21CFR820, Quality System Regulation, 21CFR11 - Electronic Records, Electronic Signatures, EudraLex, Volume 4, Good Manufacturing Practices, Annex 11 Computerized Systems)
  • Solid understanding and application towards regulatory compliance, vendor/client/regulatory audits, SxP development, Change Management, CAPA, Deviations, and Quality System Regulation disciplines
  • Based on broad technical skills and drug development experience, anticipates, and identifies unmet customer needs. Able to evaluate and assess impact of proposed changes to GMP documents and/or project scope
  • Ability to work effectively under pressure to meet deadlines and exhibit critical thinking and offer solutions. Able to prioritize and suggest alternatives or contingencies to achieve the correct technical solutions with most efficient resource utilization
  • Well organized with ability to multitask and execute multiple tasks within a given timeframe efficiently. Coaching skills are expected to train junior scientists
  • On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 pounds. Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently
  • Defined career path and annual performance review and feedback process
  • Diverse, inclusive culture
  • Positive working environment focusing on continually improving processes to remain innovative
  • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
  • 152 Hours + 8 paid holidays
  • Several Employee Resource Groups focusing on D&I
  • Dynamic, fast-paced work environment
  • Community engagement and green initiatives
  • Generous 401K match
  • Company match on donations to organizations
  • Medical, dental and vision benefits effective day one of employment
  • Tuition Reimbursement – Let us help you finish your degree or start a new degree!
  • WellHub program to promote overall physical wellness
  • Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories
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