5392- CSV Engineer / Senior Validation Engineer 2

Tbwa Chiat/Day Inc; New Jersey; On-site; USD 80,000 - 116,000; Full time

Job summary

An established industry player is seeking a skilled Computer System Validation Specialist to join their dynamic team. This role is crucial for ensuring that computer systems meet regulatory compliance standards and are validated for product manufacturing in the life sciences sector. You will collaborate with automation and validation teams, manage documentation, and conduct risk assessments while working on exciting projects that impact healthcare. With a focus on growth and innovation, this organization offers a supportive culture where your contributions will help drive success in the scientific community. If you're passionate about making a difference in life sciences, this opportunity is perfect for you.

Benefits

Competitive pay plus performance-based incentives

Company-paid Life Insurance

Short-Term and Long-Term Disability Insurance

Health Savings Account

Paid Time Off (Rollover Option)

Tuition Reimbursement

Employee Recognition

Paid Parental Leave

Team Social Activities

Paid Sick Time

Qualifications

• 5+ years of experience in Computer System Validation in a GMP-regulated environment.
• Strong knowledge of FDA regulations and cGMP standards.

Responsibilities

• Develop and execute CSV protocols for manufacturing equipment.
• Collaborate with teams to ensure compliance with project standards.

Skills

Computer System Validation

Regulatory Compliance

Documentation Skills

Communication Skills

Risk Assessment

Organizational Skills

Analytical Skills

Education

Bachelor’s degree in Engineering

Bachelor’s degree in Computer Science

Bachelor’s degree in Life Sciences

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Warren, NJ

Description

Verista’s 500 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

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
• Candidate proficient with validation of stand-alone computer systems, such as benchtop analytical instruments and lab equipment controlled by software.
• 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

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.

*Verista is an equal opportunity employer.

National (US) Range

$80,465 - $116,000 USD

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.
• Supplemental Life, Hospital, Critical Illness and Legal Insurance
• Health Savings Account
• 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

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For more information about our company, please visit us at Verista.com