Senior CSV Engineer/Analyst - Senior Validation Engineer 5245

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 Verista.com

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.

$70,491-115,000

*Verista is an equal opportunity employer.