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Senior CQV Engineer – 2632DB

Verista

This is a Full-time position in novato, CA posted January 3, 2023.

Description

Who are we:

Verista’s 700 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. Whether it’s compliance, quality management, verification, validation, automation, IT infrastructure, data analysis, manufacturing, or packaging, we deliver solutions that are right the first time.

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

Typical Project Accountabilities Include:

  • Provide technical CQV (commissioning, qualification, and verification) expertise on large capital projects involving new or modified equipment, facilities, and utilities ensuring CQV aspects are delivered consistently and efficiently. Includes authoring and executing documents such as URS, System boundary definition, Risk Assessment, Traceability matrices, Design Qualification, Start Up and Debug documentation, commissioning documents, including FAT and SAT, IQ/OQ/PQ, Turnover documentation.
  • Author and execute technical commissioning and qualification documentation for complex, automated equipment, and processes, in accordance with client’s quality standards, current Good Manufacturing Practices, (21 Code of Federal Regulations Part 210, 211 and 820 level standards which apply to the equipment and product being validated) and national/international standards.
  • Verify system drawings including ability to review and as-build P&IDs and I&C drawings as well as verifying electrical schematics with electrical engineering support.
  • Manage and work collaboratively with clients’ quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Maintain clear and detailed records of qualification and change control activities for future compliance audits.
  • Project assignments will vary by customer requirements for specific defined deliverables based on project needs and scope.

This role will support the generation, revision of IQ/OQ/PQ protocols for life science lab, computer system, manufacturing and packaging equipment and utilities. You will participate in issue identification and mitigation and generate reports.

Support Risk Assessment, Change Controls, CAPA and Engineering Documentation.

Provide technical guidance and leadership to junior staff.

Set team priorities.

Requirements

  • Candidates must live within a driveable distance to the client in Novato, CA.
  • A minimum of a bachelor’s degree in an Engineering or Scientific degree
  • 6-10 years’ experience in GMP regulated environment
  • Requires experience writing and executing GMP documentation and Validation protocols, such as IQ/OQ/PQ documents.
  • Understanding of GMP production facility utilities and their application, such as Water for Injection, Cleanrooms, HVAC, Clean Steam and process gasses
  • ASTM-E2500

Benefits

Why Verista?

  • High growth potential and fast paced organization with a people-focused culture
  • Competitive pay plus performance-based incentive programs
  • Company paid medical premiums for Employee option.
  • Company paid Life, Short-Term, and Long-Term Disability insurances
  • Dental & Vision insurances
  • Health Savings Account
  • 401(k) Retirement Plan (Employer Matching benefit)
  • Paid Time Off (Rollover Option) and Holidays
  • Leadership development training, career planning, and tuition reimbursement
  • Team Social Activities (We have fun!)
  • Employee Recognition
  • Employee Referral Program
  • Paid Maternity, Parental Leave and Bereavement

Verista is a leading business, technology and compliance company that enables clients to improve health and improve lives. We help clients solve their most critical and complex challenges across the GxP lifecycle, from preclinical and clinical to commercialization, manufacturing, and distribution. This experience brings together decades of knowledge, the most advanced engagement platforms, as well as transformative technologies. This allows clients to benefit from the ease, efficiency, and trust that results from working with one partner who excels across specialties.

For more information about our company, please visit us at Verista.com or follow us on LinkedIn.

  • Verista is an equal-opportunity employer.

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