CSV Engineer Analyst Lab SME- 3297BC

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 currently seeking Validation Engineers with experience in facilities, equipment and process validation within a pharmaceutical or biotechnology manufacturing environment to support CQV (Commissioning, Qualification & Validation) activities.

Typical Responsibilities Include:

CSV Lab Validation SME requiring onsite support of a Validation Team
Role requires someone with 7+ years of lab experience
Previous lab validation experience
Managing/leading a team a plus

Designing and executing validation including support of computer system validation protocols to ensure consistency of data production and compliance with client’s quality standards (including client procedures, and 21 Code of Federal Regulations Part 2XX and 8XX level standards which apply to the equipment and product being validated).

• Developing technical documents utilizing a simple non-technical general description. This requires understanding of lab equipment.

• Running test scripts and making recommendations for process modification based on test results.

• Owning validation process (or portion thereof) not only from an SME standpoint but also from a client and team relationship standpoint.

• Developing and writing technical change controls.

• Documenting the planning and design required to support the changes, approvals, and testing.

• Managing the overall documentation development and approval process including explanation and justification of document testing, content, and strategy from a quality and regulatory standpoint to facilitate acceptance and approval of the document by required signatories QA.

Requirements

• Life Sciences industry experience including prior experience implementing systems within a GxP environment.
• Strong experience working with SDLCs.
• Strong written and oral communication skills.
• Strong interpersonal skills.
• Experience at working both independently and in a team-oriented, collaborative environment is essential.
• Flexible during times of change.
• Can conform and swiftly adjusts to shifting priorities, demands and timelines through analytical and problem-solving capabilities.
• Manages complex issues and risks and troubleshoots them as they arise. This role will regularly interface with all levels of the organization and with external vendor

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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.
• 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 v