CSV Engineer/Analyst

Company:  Verista
Location: Boston
Closing Date: 02/11/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description

Verista’s 600 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.Company Culture Guidelines & Values:We empower and support our colleaguesWe commit to client success at every turnWe have the courage to do the right thingWe encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.We constantly acquire new skills and learn from our experiences to enhance our collective expertiseSenior CSV Engineer/Analyst Responsibilities:Provide IT CSV support to implement and validate electronic systems in accordance with corporate policies and proceduresCollaborate to gather business needs and utilize appropriate tool for tracking of the work allocatedProvide regular reporting of project timelines, issues/escalations and other metrics/KPIsWork directly with the business, validation team and other stakeholder groups for implementation, operational and development changes for the given systemsAssist in the review of change controls and associated tasks. Effectively assist to project manage projects to completionReview and provide feedback/approval on risk assessments, Validation Plans, Specifications, Test scripts, Installations Qualification Protocols, Operational Qualification Protocols, Performance Qualifications Protocols, Trace Matrices and Summary Reports associated with validated computer systemsEngage in Quality process improvement initiatives, as applicableReview and approval of defined life cycle deliverables in compliance with the governing regulations and procedures.Perform supporting quality related activities associated with computerized systems including review of change controls and test runs when applicableProvide guidance to project teams on compliance requirements for the given project as it relates to activities within scopePerform all assigned and required trainings to maintain 100% complianceRequirementsMust be willing to work onsite in Boston, MADemonstrated experience in leading CSV activities specific to Process EquipmentProficiency using PC and Microsoft Office toolsOutgoing personality with strong ability to communicate effectively with peers in clear, concise termsAbility to work as part of a teamStrong problem-solving and critical thinking skillsStrong CSV experience Veeva, ALM, GMP, etcExcellent organizational and time management skillsStrong attention to detailGMP and Good Documentation PracticeIntermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)Basic skills with EXCEL and PowerPointStrong interpersonal skills and clear communication capabilitiesExperience with and tolerance for high levels of challenge and changeExperience in GMP regulated environmentProven attention to detail and organization in project workCapable of working on assigned tasks without mentorshipBenefitsWhy Choose Verista?High growth potential and fast-paced organization with a people-focused cultureCompetitive pay plus performance-based incentive programsCompany-paid Life, Short-Term, and Long-Term Disability Insurance.Medical, Dental & Vision insurancesFSA, DCARE, Commuter BenefitsSupplemental Life, Hospital, Critical Illness and Legal InsuranceHealth Savings Account401(k) Retirement Plan (Employer Matching benefit)Paid Time Off (Rollover Option) and HolidaysAs Needed Sick TimeTuition ReimbursementTeam Social Activities (We have fun!)Employee RecognitionEmployee Referral ProgramPaid Parental Leave and BereavementFor more information about our company, please visit us at Verista.com ( US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.$85,000 - $129,826*Verista is an equal opportunity employer.

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