6461 - Senior CQV Engineer / Senior Validation Engineer

Verista, Inc.; Columbus (OH); On-site; USD 70,491 - 109,900; Full time

Benefits offered by this job

Competitive pay

Health savings account

Paid time off

Tuition reimbursement

Disability insurance

Job summary

Verista, Inc. in Columbus, OH, is seeking CQV professionals to support pharmaceutical manufacturing projects. The team delivers validation and commissioning services, ensuring compliant, validated facilities and systems.

Candidates should have strong communication, teamwork, and problem-solving skills, with experience in GMP environments and CQV activities. Onsite work in the Indianapolis metropolitan area may be required, with travel up to 50% anticipated.

Qualifications

• Bachelor’s Degree or equivalent required.
• 4 - 6 years of demonstrated role relevant experience.
• Experience leading CQV activities specific to pharmaceutical manufacturing requirements.
• Proficiency using PC and Microsoft Office tools.

Responsibilities

• Complete user interface testing, software verification, and alarm testing on automated systems.
• Develop, review, and execute testing documentation.
• Make recommendations for design or process modification based on test results.

Skills

Effective communication

Team mentoring

Problem solving

Interpersonal skills

Client liaison

GMP awareness

Education

Bachelor's degree or equivalent

Tools

Microsoft Office

Word

Excel

PowerPoint

Job description

Columbus, OH

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
• 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
• Designing and executing engineering studies for critical process parameter definition and verification prior to validation
• 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 records qualification and validation
• 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
• General understanding of capital equipment implementation and process knowledge

Requirements:

• 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 required
• 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
• 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
• 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 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
• Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
• Basic skills with EXCEL and PowerPoint
• Strong interpersonal skills and clear communication capabilities
• Experience with and tolerance for high levels of challenge and change
• Experience in GMP regulated environmentProven attention to detail and organization in project work
• Capable of working on assigned tasks without mentorship

National (US) Range

$70,491 - $109,900 USD

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.
• Supplemental Life, Hospital, Critical Illness and Legal Insurance
• Health Savings Account
• 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

Verista is an equal opportunity employer.

Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.

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

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