Senior Validation Specialist I, BioAnalytics CSV & Compliance

Catalent Pharma Solutions•Kansas City, MO

36d•Onsite

About The Position

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. The Role: 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

Requirements

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

Responsibilities

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

Benefits

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
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work.