CSV Engineer/Analyst - 5055

Posted on Sep 25, 2024 by Verista
Boston, MA
Admin & Secretarial
Immediate Start
Annual Salary
Full-Time
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.

Reference: 202387883

https://jobs.careeraddict.com/post/95563653

CSV Engineer/Analyst - 5055

Posted on Sep 25, 2024 by Verista

Boston, MA
Admin & Secretarial
Immediate Start
Annual Salary
Full-Time
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.

Reference: 202387883

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