Senior CQV Validation Engineer 2 / Senior Validation Engineer 2

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
  
  

The CQV Validation Engineer family of roles execute commissioning, qualification and validation projects involving new or modified systems/equipment, processes, procedures, products, facilities, and utilities. In this role, validation engineers support the validation and change lifecycles for client’s systems in pharmaceutical and medical device manufacturing, and packaging operations to meet timeline, budget, quality, regulatory compliance, and client expectations.

Senior CQV Validation Engineer 2 Responsibilities

• Managing the responsibilities on multiple simultaneous projects and/or clients
• Driving the activities as client facing leader and responsible party
• Act as the defined point of escalation and issue management on client projects
• Fluent in working with equipment OEMs and installation vendors
• Designing validation plans
• Conducting and documenting impact and risk assessments with a full understanding of equipment/system/ software operation and ability to assess direct, indirect, and no impact systems and functions within complex processes
• Maintaining (and ensuring the team maintains) clear, detailed records of qualification and validation, and change control activities for future compliance audits
• Independently understanding client’s quality standards, cGMP’s, and regulatory standards to support team in compliance of validation effort
• Designing and executing engineering studies for critical process parameter definition and verification prior to validation
• Independent verification of testing against specifications
• Managing and working collaboratively with clients’ quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities
• Ability to complete root cause analysis
• Supporting clients change management program – including authoring proposed changes, executing impact assessments/ regression analysis, and supporting client documentation of change results and release
• Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader
• Running test scripts and documenting results
• Adherence with project schedule for all assigned activities
• Maintaining clear, detailed qualification and validation records
• Documenting impact and risk assessments as part of a team
• Completing user interface testing, software verification, and complete alarm testing on automated systems
• Developing, reviewing, and executing testing documentation
• Making recommendations for design or process modification based on test results when executing test scripts
• Reading technical schematics to identify, locate, and test photo sensors, verify part numbers, and complete I/O testing on automated manufacturing equipment
• General understanding of capital equipment implementation and process knowledge
• Understanding validation documents, URS, IQ, OQ, PQ
• Verifying system drawings including ability to review and as-built P&IDs (piping and instrumentation drawings) and I&C (instrumentation and controls) drawings as well as verifying electrical schematics with support of an electrical engineer
  
  

Requirements

• 6 - 10 years of role relevant experience
• Ability to take independent leadership role on project(s)
• Proven ability to identify areas of business expansion and initiate technical discussion on Verista solutions for business expansion
• Demonstrated project leadership capabilities
• Ability to architect validation programs and execute against complex project tasks
• Advanced Microsoft Project capabilities
• 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
• Ability to mentor and guide less experienced team members
• Ability to communicate effectively with clients
• Proven ability to identify areas of business expansion and report to management team for follow-up
• Experience in pharmaceutical cGxP setting with the ability to generate CQV deliverables independently
• Proven attention to detail and organization in project work
• Ability to work independently and as part of a team, with the ability to transition between the two
• Bachelor’s Degree or equivalent required
• Capacity to make independent sound decisions and independently manage priorities
• Advanced Microsoft WORD, EXCEL, and PowerPoint capabilities.
• Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms
• Ability to work as part of a team
• Strong problem-solving and critical thinking skills
• Excellent organizational and time management skills
• Strong attention to detail
• GMP and Good Documentation Practice training (may be completed at onboarding)
• Strong interpersonal skills and clear communication capabilities
• Experience with and tolerance for high levels of challenge and change
  
  

This is a 100% onsite role in Rocky Mount, NC.

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—$127,144 USD

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
  
  

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