Senior CSV Engineer/ Lead Validation Engineer

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 CQV Engineer Responsibilities:

• Responsible for supporting the validation activities for local and global systems
• Coordinate with technical evaluation with site subject matter experts (SMEs) of new and existing systems from a DI and CSV perspective
• Perform data integrity gap assessment and develop remediation plan for computerized systems.
• Responsible for creating CAPA’s/Deviations and Change Requests in ServiceNow and Trackwise
• Responsible for coordinating with cross-functional teams to ensure the alignment of the validation activities
• Manage the validation and documentation related to complex computer systems, multiple pieces of equipment/large upgrades/extensive product updates
• Perform functions of validation engineer – draft Validation Plans, Requirements, Test Cases, Summary Reports
• Change management process owner for validation involving new or modified equipment, processes, procedures, and products. In this role, validation engineers design and perform validation around lab equipment and computer systems.
• Determine and delegate tasks amongst a team to complete assignment
• Conduct impact analysis for validation and change management
• Coordinate teams to complete validation testing activities
• Manage complete document management and approval through client’s process
• Conducts regulatory impact analysis/assessment and, where warranted, makes recommendations
• Act as the Subject Matter Expert for project deliverables

Requirements

• Experience in developing and maintaining validation documentation including validation plans, test protocols, test scripts, and summary reports to align with company SOP and regulatory standards
• Experience using HPALM for authoring and executing the Test scripts
• Experience in performing/supporting computer validations associated with SDLC deliverables
• A minimum of a Bachelor’s degree in an Engineering or Scientific degree and 7-10+ industry experience
• Must be willing to work onsite in Concord, NC
• 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
• Proven attention to detail and organization in project work
• Capable of working on assigned tasks without mentorship

Preferred:

• 10+ years’ experience in GMP regulated environment (with Internship or co-op work experience considered as part of that experience)
• Direct experience authoring/editing/executing validation documents for laboratory equipment (Cat. A, B &C)
• Expert knowledge of FDA regulations, ISPE guidelines and ISO standards including: Good Documentation Practice (GDP) in pharmaceutical environment and 21 CFR Part 11

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.

$87,780-145,405

*Verista is an equal opportunity employer.