6459 - Senior CQV Engineer / Senior Validation Engineer

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

Benefits offered by this job

Life Insurance

Disability Insurance

Tuition Reimbursement

Paid Time Off

Holidays

Health Savings Account

Team Social Activities

Employee Recognition

Employee Referral Program

Paid Parental Leave and Bereavement

Job summary

Verista, Inc. in Indianapolis is looking for an experienced CQV professional to lead qualification and validation activities for pharmaceutical manufacturing. You will mentor teammates, communicate with clients at multiple levels, and ensure GMP/GDP standards are followed in a fast-paced environment.

Requirements include a Bachelor's degree, 4–6 years of relevant experience, and strong proficiency with MS Word, Excel and PowerPoint. This is an onsite role with potential travel (10–50%).

Qualifications

• Bachelor’s Degree or equivalent required.
• 4 - 6 years of demonstrated role relevant experience.
• Demonstrated experience in leading CQV activities specific to pharmaceutical manufacturing requirements.
• Ability to mentor and guide less experienced team members.
• Ability to communicate effectively with clients at different levels.
• GMP and Good Documentation Practice experience.
• Proficiency using PC and Microsoft Office tools.

Skills

Mentoring

Client communication

Team collaboration

Problem solving

Organizational skills

Attention to detail

GMP knowledge

Communication with client levels

Education

Bachelor’s Degree or equivalent

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Indianapolis, IN

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 environment
• Proven attention to detail and organization in project work
• Capable of working on assigned tasks without mentorship

*Verista is an equal opportunity employer.

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.

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 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