Senior CSV Engineer/Analyst - Senior Validation Engineer 5392

Verista
US - New Jersey - Warren Grove
January 15, 2025

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 Responsibilities:

We are seeking a skilled Computer System Validation (CSV) Specialist to support the commissioning and qualification (C&Q) efforts for a cell therapy manufacturing project. This role ensures that computer systems meet regulatory compliance standards and are validated to facilitate product manufacturing.

Responsibilities Include:

Develop and execute CSV protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for manufacturing equipment

Collaborate closely with automation and validation teams to ensure systems meet project and regulatory compliance standards

Manage the document lifecycle, including creation, revision, and storage, in compliance with project documentation systems

Participate in weekly project meetings to coordinate with system owners and management for alignment on project needs and issue resolution

Conduct risk assessments and generate compliance reports, managing deviations and ensuring all required documentation meets quality and regulatory standards

Oversee vendor interactions, including reviewing and tracking vendor deliverables and system qualifications

Requirements

Bachelor's degree in a relevant field (e.g., Engineering, Computer Science, Life Sciences)

Minimum of 5 years of experience in Computer System Validation in a GMP-regulated environment, ideally within pharmaceuticals or biotechnology

Strong knowledge of regulatory compliance requirements (e.g., FDA regulations, cGMP standards) and quality systems

Experience with DeltaV control systems and document management systems

Excellent organizational, communication, and documentation skills

Ability to work effectively both independently and as part of an integrated project team

Must be available to work onsite at client site in Warren, NJ (On-site; some degree of remote work possible with approval)

Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate

Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client's organization

Demonstrated ability to generate CSV deliverables independently

Ability to work independently and as part of a team, with the ability to transition between the two

Capacity to make independent sound decisions and independently manage priorities

Advanced Microsoft WORD, EXCEL, and PowerPoint capabilities

5 years minimum of relevant experience

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.

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• Verista is an equal opportunity employer.

Read the full job description and apply online on the recuiter's web-site

Senior CSV Engineer/Analyst - Senior Validation Engineer 5392

Senior CSV Engineer/Analyst - Senior Validation Engineer 5392

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