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Catalent · 2 days ago

Senior Validation Specialist I, BioAnalytics CSV & Compliance

Kansas City, MO

Full-time

Onsite

Mid, Senior Level

4+ years exp

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) dedicated to improving lives through innovative products. The Senior Validation Specialist I will lead and manage Computer System Validation (CSV) and Data Integrity Programs at the BioAnalytics site, ensuring compliance with regulatory guidelines and overseeing the development of technical documents.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

Responsibilities

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

Qualification

Computer System Validation (CSV)Data Integrity Programs (DI)Manufacturing Practices (GMP)Regulatory ComplianceQuality System RegulationProject ManagementCoaching SkillsMultitaskingTechnical WritingCritical Thinking

Required

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

Physical requirements: 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

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

Company

Catalent

Catalent - Blow-Fill-Seal Sterile CDMO Business is focusing on complex clinical to commercial stage formulation and manufacturing. It is a sub-organization of Catalent Pharma Solutions.

Founded in 2007

Somerset, New Jersey, USA

10001+ employees

https://www.catalent.com

H1B Sponsorship

Catalent has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2022 (1)