CSV Engineer/Analyst - 5055

Posted 2 Days Ago
Be an Early Applicant
Boston, MA
85K-130K Annually
Mid level
Pharmaceutical
The Role
As a Senior CSV Engineer/Analyst at Verista, you will provide IT CSV support for implementing and validating electronic systems, collaborate with stakeholders on project tracking, review documentation for compliance, and engage in quality improvement initiatives. You’ll also manage project timelines and assist in change controls for computer systems.
Summary Generated by Built In

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 colleagues
  • We commit to client success at every turn
  • We have the courage to do the right thing
  • We 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 expertise

Senior CSV Engineer/Analyst Responsibilities:

  • Provide IT CSV support to implement and validate electronic systems in accordance with corporate policies and procedures
  • Collaborate to gather business needs and utilize appropriate tool for tracking of the work allocated
  • Provide regular reporting of project timelines, issues/escalations and other metrics/KPIs
  • Work directly with the business, validation team and other stakeholder groups for implementation, operational and development changes for the given systems
  • Assist in the review of change controls and associated tasks. Effectively assist to project manage projects to completion
  • Review 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 systems
  • Engage in Quality process improvement initiatives, as applicable
  • Review 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 applicable
  • Provide guidance to project teams on compliance requirements for the given project as it relates to activities within scope
  • Perform all assigned and required trainings to maintain 100% compliance
Requirements
  • Must be willing to work onsite in Boston, MA
  • Demonstrated experience in leading CSV activities specific to Process Equipment
  • Proficiency using PC and Microsoft Office tools
  • Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms
  • Ability to work as part of a team
  • Strong problem-solving and critical thinking skills
  • Strong CSV experience Veeva, ALM, GMP, etc
  • Excellent organizational and time management skills
  • Strong attention to detail
  • GMP and Good Documentation Practice
  • Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
  • Basic skills with EXCEL and PowerPoint
  • Strong interpersonal skills and clear communication capabilities
  • Experience with and tolerance for high levels of challenge and change
  • Experience in GMP regulated environment
  • Proven attention to detail and organization in project work
  • Capable of working on assigned tasks without mentorship
Benefits

Why Choose Verista?

  • High growth potential and fast-paced organization with a people-focused culture
  • Competitive pay plus performance-based incentive programs
  • Company-paid Life, Short-Term, and Long-Term Disability Insurance.
  • Medical, Dental & Vision insurances
  • FSA, DCARE, Commuter Benefits
  • Supplemental Life, Hospital, Critical Illness and Legal Insurance
  • Health Savings Account
  • 401(k) Retirement Plan (Employer Matching benefit)
  • Paid Time Off (Rollover Option) and Holidays
  • As Needed Sick Time
  • Tuition Reimbursement
  • Team Social Activities (We have fun!)
  • Employee Recognition
  • Employee Referral Program
  • Paid Parental Leave and Bereavement

For more information about our company, please visit us at 

For 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.

Top Skills

Csv
The Company
HQ: Fishers, IN
402 Employees
On-site Workplace
Year Founded: 2020

What We Do

Verista is a leading business and technology consultancy firm that provides systems, compliance, validation and quality solutions to life science companies - enabling them to improve health and improve lives. We help clients solve their most critical and complex challenges across the GxP lifecycle, from preclinical and clinical to commercialization, manufacturing and distribution – bringing together decades of knowledge, the most advanced engagement platforms and transformative technologies. This allows clients to benefit from the ease, efficiency and trust that results from working with one partner who excels across specialties. Verista’s clients trust the company’s 650+ experts to deliver consistent, safe, and high-quality results across the product development lifecycle. Verista is based in Fishers, Indiana, Wayne, Pennsylvania, Westford, Massachusetts, and San Mateo, California. For more information, visit www.verista.com

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