Senior CSV Engineer Analyst - 3432BC

Verista’s 700 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. Whether it’s compliance, quality management, verification, validation, automation, IT infrastructure, data analysis, manufacturing, or packaging, we deliver solutions that are right the first time.

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

Verista is looking to hire Computer Systems Validation Leads to join our Quality & Compliance Solution Center in Fort Wayne, IN. Seeking recent graduates to learn from our team of Life Sciences industry-leading experts, regulatory specialists, and project managers. Selected candidates will gain an understanding of Computer Systems Validation (CSV) and Commissioning, Qualification & Validation (CQV) through rotational field assignments, with the goal of providing a foundation to grow your Quality & Compliance career.

Requirements

Responsibilities Include:

Produce quick deliverables and meet timelines
- Stick with the work plan – negotiate a date instead of just saying you can pull it off
- Lot of critical projects – some limping along is okay
- Onsite would be preferred
- Manufacturing experience
• Review/Approve Test Scripts
• Review Validation Summary Reports, Installation Qualification, Operational Qualification, Performance Qualification, and Trace Matrices, escalate issue to management
• Support the development of training content
Direct reports

This position will not have direct reports

• 5+ years relevant Quality Assurance experience in a pharma/biotech company, working within a regulated GMP environment.
• Prior experience with implementing software systems and/or continuous improvement initiatives focused on software systems
• Ability to partner cross functionally and integrate feedback during development and implementation of quality systems
• Ability to work independently to meet objectives and timelines
• Has an awareness of cGMP and ICH regulations/ guidelines and GAMP-5
• Prior experience with electronic test systems preferred (e.g. Valgenesis, Kneat)

#LI-RC1

Benefits

Why Verista?

• High growth potential and fast paced organization with a people-focused culture
• Competitive pay plus performance-based incentive programs
• Company paid medical premiums for Employee option.
• Company paid Life, Short-Term, and Long-Term Disability insurances
• Dental & Vision insurances
• Health Savings Account
• 401(k) Retirement Plan (Employer Matching benefit)
• Paid Time Off (Rollover Option) and Holidays
• Leadership development training, career planning, and tuition reimbursement
• Team Social Activities (We have fun!)
• Employee Recognition
• Employee Referral Program
• Paid Maternity, Parental Leave and Bereavement

Verista is a leading business, technology and compliance company that enables clients to improve health and improve lives. We help clients solve their most critical and complex challenges across the GxP lifecycle, from preclinical and clinical to commercialization, manufacturing, and distribution. This experience brings together decades of knowledge, the most advanced engagement platforms, as well as transformative technologies. This allows clients to benefit from the ease, efficiency, and trust that results from working with one partner who excels across specialties.

For more information about our company, please visit us at Verista.com or follow us on LinkedIn.

*Verista is an equal-opportunity employer.