6459 - Senior CQV Engineer

The role

The Senior CQV Engineer will design validation plans and conduct impact and risk assessments. They will author, edit, and execute technical commissioning, qualification, and validation documentation for equipment, systems, and software.

What you will do

• Designing validation plans
• Conducting and documenting impact and risk assessments
• Maintaining clear, detailed records of qualification and validation and change control activities
• Designing and executing engineering studies for critical process parameter definition and verification
• Authoring, editing, and executing technical commissioning, qualification and validation documentation
• Running test scripts and documenting results
• Adherence with project schedule for all assigned activities
• 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

Required qualifications

• Must be able/willing to work onsite in the Indianapolis metropolitan area
• Must be willing to meet potential future travel requirements (10-50%)
• Bachelor’s Degree or equivalent
• 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
• Obvious business maturity and interpersonal skills
• Experience and capability of effectively communicating requirements with rationale to different levels of the client’s organization
• 4 - 6 years of demonstrated role relevant experience
• Demonstrated experience in leading CQV activities specific to pharmaceutical manufacturing requirements
• Proficiency using PC and Microsoft Office tools
• Outgoing personality with strong ability to communicate effectively with peers

Benefits

• 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
• Employee Recognition

About the company

Verista's 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The company provides innovative solutions and services that empower informed decision-making.