6460 - Senior CQV Engineer / Senior Validation Engineer

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

Senior CQV Engineer Responsibilities:

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

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

Understanding validation documents, URS, IQ, OQ, PQ

Requirements:

Must be able/willing to work onsite in the Raleigh/Durham 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

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

$70,491 — $109,900 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