6546- Senior CSV Engineer / Senior Validation Engineer

The Role

What You'll Do

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
• 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

Qualifications

• 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
• 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
• 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

Preferred Qualifications

• Experience with lab systems (LIMS, Empower/CDS, HPLC, GC) is a plus
• Digital Validation experience preferred

Responsibilities

• 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