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Senior Validation Engineer 2916AE

Verista

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

Description

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.

Senior Validation Engineer Responsibilities:

  • Authoring and executing technical commissioning and qualification documentation for complex, automated equipment, and processes, which includes compliance with client’s quality standards, current Good Manufacturing Practices, (21 Code of Federal Regulations Part 2XX and 8XX level standards which apply to the equipment and product being validated) and national/international standards.
    • Completing commissioning and validation activities taking an engineering approach including identifying performance issues and solutions, recommending design or process modification, and verifying that our clients’ equipment maintains SISPQ.
  • Authoring, editing, and executing validation documents for equipment, facilities and/or utilities including but not limited to:
    • Life cycle document management
    • System requirements and description (URS)
    • System boundary definition
    • Traceability matrices
    • Design Qualification (DQ) including Functional Design and Software Design Specification Development
    • Start Up and Debug documentation
    • Commissioning document development and execution, including FAT and SAT
    • IQ/OQ/PQ
    • Turnover documentation
  • Designing and executing engineering studies for critical process parameter definition and verification prior to validation.
  • Conducting and documenting impact and risk assessments with a full understanding of equipment operation and ability to assess direct, indirect, and no impact systems and functions within complex, high speed automated process and packaging equipment
  • Verifying system drawings including ability to review and as-built P&IDs (piping and instrumentation drawings) and I&C (instrumentation and controls) drawings as well as verifying electrical schematics with support of an electrical engineer.
  • Reading technical schematics to identify, locate, and test photo sensors, verify part numbers, and complete I/O testing on automated manufacturing equipment.
  • Completing user interface testing, software verification, and complete alarm testing on automated manufacturing equipment (e.g., Rockwell RSView ME user interface and AB ControlLogix PLC).
  • Performing onsite validation Verista’s clients.
  • Developing, reviewing, and completing Installation Check (IC) documentation; including verification of engineering components, drawings and specifications utilizing technical engineering background and expertise.
  • Developing and conducting computer system validation.
  • Owning entire CQV process for and adherence with project schedule for all assigned equipment and components.
  • Maintaining clear, detailed records of qualification, and change control activities for future compliance audits.
  • Managing and working collaboratively with clients’ quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Includes ability to complete root cause analysis and address complex automated equipment issues to ensure successful validation and compliance.
  • Working with vendors to ensure equipment meets design intent/specifications (IQ/CQ).

Requirements

You will have:

  • This position requires a minimum of a Bachelor’s degree in an Engineering or Scientific degree.
  • Experience in GMP regulated environment commensurate with Job Level Differentiators defined below.
  • Technical understanding and experience with automated equipment for manufacturing, device assembly, and packaging (PLCs, HMIs, PC based controls).
  • Direct experience authoring/editing/executing validation documents for equipment/facilities/utilities including FAT, IQ, OQ, PQ and change controls
  • Intermediate knowledge of FDA regulations, ISPE guidelines and ISO standards including:
    • Good Documentation Practice (GDP) in pharmaceutical environment
    • ASTM-E2500
    • ISO 14971 – risk management for medical devices
    • ISPE Applied Risk Management for C&Q
    • ISPE Science and Risk Based Approach for the delivery of facilities, systems, and equipment
    • ICH 8, 9, 10 – Knowledge of Risk management and Risk Analysis Tools
    • 21 CFR Part 2XX and 8XX level regulations and interpretation as applied in the above standards.
  • Experience and knowledge of mechanical systems and clean utilities including ability to read electrical, mechanical, P&ID (piping and instrument) and facility drawings

Desired Skills:

  • Preferable experience includes process equipment, protocol execution, and summary report writing

If you are qualified, have leadership potential and a willingness to learn, Verista could be the right career choice for you!

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.