6546- Senior CSV 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

The Role

We're looking for a Senior Validation Engineer with deep CSV experience. You'll design and carry out validation activities on your own, in line with regulations and quality requirements. You'll give technical guidance to other team members, work directly with clients, and potentially support more than one project at a time.

What You'll Do

Design validation plans and strategies for GxP computerized systems, including enterprise, lab, and IT systems

Author, review, and execute CSV deliverables, including impact and risk assessments, requirements and specifications, test protocols, and summary reports

Run impact and risk assessments with a full understanding of how the system works, and classify systems and functions as direct, indirect, or no impact

Independently verify testing against specifications, and make recommendations for design or process changes based on test results

Work with the client's quality representatives on deviation investigations, root cause analysis, and resolution

Support the client's change management program by authoring proposed changes, running impact and regression assessments, and documenting change results and release

Evaluate system integrations: how they're designed and built, how data flows from source to target systems, and how to test them

Keep clear, detailed records of qualification, validation, and change control activities so they're ready for future audits, and make sure the team does the same

Mentor and guide less experienced team members

Communicate requirements, with the reasoning behind them, clearly in writing and in person to all levels of the client's organization

Spot opportunities to expand the business and pass them to management for follow-up

What You Bring

Bachelor's degree or equivalent

MINIMUM of 4–6 years of CSV specific validation experience in the pharmaceutical, biotech, or medical device industry

A track record of producing CSV deliverables independently in a cGxP-regulated environment

Strong knowledge of cGMPs, Good Documentation Practices, and regulatory expectations for computerized systems (such as 21 CFR Part 11, EU Annex 11, and GAMP 5)

Hands-on experience with system design and/or configuration, and familiarity with business processes in areas such as R&D, Clinical, Quality Systems, Supply Chain, or Commercialization

Experience with lab systems (LIMS, Empower/CDS, HPLC, GC) is a plus

Advanced Microsoft Word, Excel, and PowerPoint skills. Intermediate Microsoft Project skills

Professional maturity, strong interpersonal skills, and good judgment. You can set your own priorities and make sound decisions on your own

Strong problem-solving skills, attention to detail, and organization

Digital Validation experience preferred

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 — $110,000 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