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Lead CSV Specialist

2 months ago

Indianapolis Indiana, United States Verista Full time

At Verista, our team of over 600 professionals collaborates with some of the most esteemed names in the life sciences sector to address their operational challenges.

Our mission is to foster growth and innovation within the scientific community, assisting researchers, organizations, and enterprises in tackling significant healthcare issues.

We offer cutting-edge solutions and services that facilitate informed decision-making, stemming from our substantial investment in our workforce and capabilities.


Our growth is propelled by exceptional individuals who excel in a collaborative environment and share our commitment to helping life sciences clients enhance lives.

Our dedicated and skilled professionals strive to make a meaningful impact every day.



Company Culture Principles & Values:
We empower and support our colleagues.

We are dedicated to client success at every opportunity.

We possess the courage to act ethically.

We promote an inclusive atmosphere where our team members feel valued, engaged, and challenged.

We continuously seek to acquire new skills and learn from our experiences to enhance our collective expertise.

Key Responsibilities of the Senior CSV Engineer:

  • Oversee the validation and documentation associated with intricate computer systems, extensive equipment upgrades, and significant product modifications.
  • Execute the responsibilities of a validation engineer, including drafting Validation Plans, Requirements, Test Cases, and Summary Reports.
  • Manage systems and processes for change control and coordinate the assessment of proposed changes to laboratory equipment.
  • Serve as the change management process owner for validation involving new or modified equipment, processes, procedures, and products. In this capacity, validation engineers design and execute validation for laboratory equipment and computer systems.
  • Identify and assign tasks within a team to ensure project completion.
  • Conduct impact assessments for validation and change management.
  • Coordinate teams to carry out validation testing activities.
  • Oversee comprehensive document management and approval through the client's processes.
  • Perform regulatory impact assessments and, when necessary, provide recommendations.
  • Act as the Subject Matter Expert on various laboratory equipment.
Requirements

  • A minimum of a Bachelor's degree in an Engineering or Scientific discipline, along with three to seven years of industry experience.
  • Willingness to work onsite.
  • Strong business acumen and interpersonal skills to effectively communicate and collaborate.
  • Proven ability to articulate requirements (both written and verbally) with rationale to various levels within the client's organization.
  • Demonstrated attention to detail and organizational skills in project work.
  • Ability to work independently on assigned tasks without supervision.

Preferred Qualifications:

  • 4+ years of experience in a GMP-regulated environment (internship or co-op experience may be considered).
  • Direct experience in authoring, editing, and executing validation documents for laboratory equipment (Categories A, B, & C).
Intermediate knowledge of FDA regulations, ISPE guidelines, and ISO standards, including:

Good Documentation Practices (GDP) in a pharmaceutical context.

21 CFR Part 11.

Benefits:

Why Choose Verista?

High growth potential within a dynamic organization that prioritizes its people.

Competitive compensation along with performance-based incentive programs.

Company-sponsored Life, Short-Term, and Long-Term Disability Insurance.

Medical, Dental, and Vision insurance options.

Flexible Spending Account (FSA), DCARE, and Commuter Benefits.

Supplemental Life, Hospital, Critical Illness, and Legal Insurance.

Health Savings Account.

401(k) Retirement Plan with Employer Matching.

Generous Paid Time Off (with rollover option) and Holidays.

As Needed Sick Time.

Tuition Reimbursement.

Team Social Activities (we believe in having fun).

Employee Recognition Programs.

Employee Referral Incentives.

Paid Parental Leave and Bereavement Support.

For more information about our company, please visit our website.